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Rapid Responses: Rapid Responses published:
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Conversion to Open Surgery during Laparoscopic Procedures
- Simon W Atkinson (16 January 2004)
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Consider Minilaparotomy Hysterectomy also as an option
- Jai B Sharma MD, MRCOG, Prof Suneeta Mittal MD, FAMS (18 January 2004)
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Level of pain cannot be commented on
- Stephen M F Saunders (19 January 2004)
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Conversion to abdominal hysterectomy is not a complication
- David J R Hutchon (28 January 2004)
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The bright future of laparoscopic hysterectomy
- Michel J Canis, Michel Canis, Arnaud Wattiez, Gérard Mage (2 February 2004)
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Could a high rate of complications be explained?
- Jacques DONNEZ, Jean Squifflet, Pascale Jadoul, Mireille Smets (4 February 2004)
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Laparoscopic vs. Abdominal Hysterectomy
- Larry R Glazerman (11 February 2004)
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Subtotal hysterectomy-a forgotten operation
- Makarand K Oak (13 February 2004)
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More on the comparison of laparoscopic hysterectomy with conventional hysterectomy
- Thulasimani Munisamy, Ramaswamy Subramanian,Department of Pharmacology,Aarupadai Veedu Medical College,Kirumampakkam,Pondicherry-607 421, India (25 February 2004)
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Evaluating eVALuate!
- Ashwini K Trehan, WF13 4HS (5 March 2004)
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How and when to operate laparoscopically
- Ivo A. Brosens (18 March 2004)
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Laparoscopic hysterectomy versus abdominal/vaginal hysterectomies: the need to consider adhesions risk
- Adrian Lower, Robert Hawthorn (8 April 2004)
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Time to re-evaluate eVALuate.
- Roger A. McMaster-Fay (13 January 2006)
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Simon W Atkinson, Consultant Upper GI Surgeon Guy's & St Thomas' NHS Trust, SE1 7EH
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Sir Although this paper does well to look closely at outcomes for different surgical techniques, I have serious concerns about the criteria used to classify major complications. It is routine practice, at least in laparoscopic cholecystectomy, to consent patients for conversion to an open procedure. This is recognised as prudent surgery if persisting with the laparoscopic approach would add risk. To classify, therefore, a strategy that encourages caution as a major complication, runs the risk of dissuading surgeons from converting appropriately and in a timely manner. In addition it presumably opens the way for complaints and possibly litigation should a laparotomy be required. It is widely accepted in laparoscopic gastrointestinal surgery that although conversion rates should be kept as low as possible and audited appropriately, conversion to an open procedure per se is not a major complication. The particular problem encountered may arise from the disease process itself or, indeed, from an iatrogenic injury. The cause of conversion, not the conversion itself, may be the major complication. I note that none of the authors are gastrointestinal surgeons and I feel they were badly advised during their trial discussions. Competing interests: None declared |
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Jai B Sharma MD, MRCOG, Assistant Professor in Obst & Gynaecology All India Institute of Medical Sciences, New Delhi 110029, Prof Suneeta Mittal MD, FAMS
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The two parallel randomised trials comparing laparoscopic hysterectomy with abdominal hysterectomy and the other comparing laparoscopic with vaginal hysterectomy by Gary et al is a welcome study but the results are hardly surprising and are quite expected. But a higher major complication rate with laparoscopic route is very worrying. The complications are bound to be higher in centres performing laparoscopic hysterectomies less often.Also we must not forget the prohibitingly high costs of laparoscopic setup especially in developing countries. Unfortunately laparoscopic surgery is latest fashion amongst doctors and patients alike. Some gynaecologists who are not competent to perform laparoscopic surgery tend to suffer from an inferiority complex and tend to perform laparoscopic surgery at any cost which can be dangerous. This tendency must be avoided. As is clear from this biggest ever randomised trial, laparoscopic route has no advantage over abdominal route and can be dangerous. The other trial comparing laparoscopic route with vaginal also confirms already known fact that vaginal hysterectomy is superior to laparoscopic assisted vaginal hysterectomy in less time taken, less need of expensive equipments and lesser training required. Infact vaginal hysterectomy can be performed for most uteruses upto 12 weeks size using some modifications including a recently reported ' Purohit's technique from India' in which right angle forceps, electrocautery and 10 mm telescope are used to perform nondescent vaginal hysterectomy (1). We have reported good results with minimum hospital stay and minimum post operative complications and early recovery with minilaparotomy hysterectomy, a technique which can easily be learnt and does not require expensive equipments(2,3). We have developed Sharma's uterine holding clamps to hold the uterus outside the abdominal cavity which makes the technique very easy.We routinely perform minilaparotomy for hysterectomy, ectopic pregnancy and tubal surgeries ( recanalisation and tuboplasty) wherever possible and are satisfied with our results(2-5). We feel the gynaecologists should master vaginal route of hysterectomy which is a natural route and can be learnt with good training. Minilaparotomy technique deserves a place too in many gynaecological surgeries like hysterectomy, tuboplasty and ectopic pregnancies. References 1. Purohit RK. Purohit technique of vaginal hysterectomy: a new approach. Br J Obstet Gynaecol 2003; 110: 1115-1119. 2.Sharma JB. Minilaparotomy abdominal hysterectomy- A new surgical technique. Obs Gyn Commun 1999; 1: 36-41. 3. Sharma JB, Wadhwa L, Malhotra M, Arora R. Minilap versus conventional laparotomy for abdominal hysterectomy: a comparative study. Ind J Med Sci ( In press). 4.Sharma JB, Gupta S, Malhotra M, Arora R. A randomized controlled comparison of minilaparotomy and laparotomy in ectopic pregnancy cases. Ind J Med Sci 2003; 57: 493-500. 5. Sharma JB, Malhotra M, Arora R. Minilaparotomy recanalisation and tuboplasty. J Obstet Gynaecol India ( In press). Competing interests: None declared |
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Stephen M F Saunders, SpR General Surgery Royal London Hospital
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Sir I read with anticipation the article by Garry et al. (BMJ 2004; 328: 129- 133), which promised to be one of the first randomised clinical trial of laparoscopic, abdominal and vaginal hysterectomy. We feel the authors failed to draw the correct conclusions because of their poor study design. The patients were randomised into either the abdominal or vaginal trial at the start. Both groups underwent hysterectomy under general anaesthetic although there was no mention of which anaesthetic agents were used or that every patient had undergone the same anaesthetic as different anaesthetics do have different analgesic properties. There was also no record of the names of the post operative parenteral analgesic which were administered. These can significantly affect the post operative pain scores. The authors did not state how the patients were told to record their pain scores. The paper just comments on perceived pain, but does not say how often scores were taken, whether this was the maximum pain experienced or whether this was the pain post defecation. Therefore the conclusions drawn were inaccurate if not misleading. Competing interests: None declared |
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David J R Hutchon, Consultant Obstetrician and Gynaecologist Memoiral Hospital, Darlington. DL3 8QZ
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Abdominal hysterectomy is the commonest method of carrying out hysterectomy. Other methods are used but the back stop is always an abdominal incision. The abdominal hysterectomy/ laparoscopic hysterectomy arm of this study was intended to determine whether an abdominal incision was a routine requirement for safe hysterectomy or whether it could (sometimes or always) be avoided using a laparoscopic technique. Consider a study to investigate whether or not routine antibiotics are necessary in Cesarean section or whether the antibiotic can be prescribed only if there are indications of infection. The prescription of an antibiotic was not in itself a measure of morbidity in the outcome.(1) In the same way a laparotomy incision is prudent treatment when a continued laparoscopic approach is found to be inappropriate at any stage of the operation. In itself it is not a complication but, as has already been pointed out, a prudent action in the same way that prescribing an antibiotic for a suspected infection is a prudent action. However if the reason for moving to a laparotomy is major haemorrhage, ureteric injury or bowel injury then these are the major complications which need to be included in the analysis. When a laparotomy is undertaken because the nature of the surgery cannot be undertaken safely laparoscopically, the patient is no worse than if they had embarked on abdominal hysterectomy from the start. I decided against taking part in this study because I was unhappy about the design. I think a case match study using the surgeons own selected technique would have been preferable and would have reflected current practice. My own feeling is that laparoscopic surgery should be used to facilitate a vaginal hysterectomy rather than replace vaginal hysterectomy. I would have found it ethically difficult to treat a patient randomised to the laparoscopic arm if I had already considered a vaginal hysterctomy was feasable. This study appears to confirm my view. Ref. 1.Smaill F, Hofmeyr GJ. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev 2001: Issue 3. Competing interests: I believe that laparoscopic assisted vaginal hysterectomy is a valuable surgical treatment. |
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Michel J Canis, Professore OBS GYN Polyclinique CHU Bd Leon Malfreyt 63000 Clermont Ferrand France, Michel Canis, Arnaud Wattiez, Gérard Mage
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We read with interest the article by Garry et al. (1) They " demonstrated " that laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. Surely to arrive at such an important conclusion, the comparison between the techniques should be fair. Was it really possible to compare two techniques when one had been used and taught for 100 years and the other for only a few months ? Reporting a large series of 1647 cases, we demonstrated that the learning curve for laparoscopic hysterectomy is much greater than 25 cases.(2) In a team involved in laparoscopic surgery for more than 10 years before its first laparoscopic hysterectomy(3), a 6-year period and more than 600 cases were necessary to complete the learning curve. Comparing patients operated on between 1989 and 1995 to those operated on between 1996 and 1999, we found interesting differences. The incidence of conversion to laparotomy decreased from 4.7% (33 cases out of 695) to 1.4% (13 cases out of 952) and the incidence of major complications from 5.6% to 1.3%, while the mean uterine weight increased from 179g (22 -904) to 292g (40-980). Similarly, the percentage of laparoscopic hysterectomy among non-vaginal hysterectomies increased from 68% to 94.4%, the operating time decreased from 115 min to 90 min and the number of surgeons involved in the study increased from 9 to 18. As we pioneered the technique, our learning curve was probably longer, but a learning curve of 25 cases is insufficient, particularly when studying major complications which are, fortunately, not frequent and when unplanned laparotomy is included as a major complication. This is borne out by the much higher major complication rate observed when pedicles were sutured. Laparoscopic suturing is difficult to master and requires extensive training. We therefore suggest that - it was probably too early to design such an ambitious trial. - the increased major complication rate would be valid if the study were repeated today by teams who have been using a laparoscopic approach for more than 5 years. - the main conclusion of the study cannot be accepted and should not be used to determine that laparotomy is required when a vaginal approach appears impossible. In contrast, this trial confirmed all the well known advantages of the laparoscopic approach over abdominal hysterectomy : decreased pain, improved quality of life, shorter recovery.…… It also demonstrated that the accuracy of the surgical diagnosis is much better by laparoscopy than by the abdominal or vaginal approach. This advantage is crucial, as every surgeon knows that an accurate diagnosis is the key to optimal treatment of any medical condition. As we are entirely convinced, based on our own experience, that the major complication rate decreases significantly when the learning curve has been completed with the most recent technique obtaining the best postoperative results despite a higher incidence of complications, we suggest that this study is actually the first to demonstrate the bright future of laparoscopic hysterectomy. Developing this technique took a long time and the initial results were sometimes disappointing. We are happy to see that data from evidence-based medicine has confirmed our initial hypothesis. 1 - Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J, Clayton R, Abbott J, Phillips G, Whittaker M, Lilford R, Bridgman S. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ. 2004 Jan 17;328(7432):129. 2 - Wattiez A, Soriano D, Cohen SB, Nervo P, Canis M, Botchorishvili R, Mage G, Pouly JL, Mille P, Bruhat MA. The learning curve of total laparoscopic hysterectomy: comparative analysis of 1647 cases. J Am Assoc Gynecol Laparosc. 2002 Aug;9(3):339-45. 3 - Bruhat MA, Manhes H, Mage G, Pouly JL. Treatment of ectopic pregnancy by means of laparoscopy. Fertil Steril. 1980 Apr;33(4):411-4. Competing interests: None declared |
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Jacques DONNEZ, Catholic University of Louvain, Cliniques Universitaires Saint-Luc Dept. of Gynecology,B-1200 Brussels, Belgium, Jean Squifflet, Pascale Jadoul, Mireille Smets
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We read with interest the paper by Garry et al (1). The aim of their prospective study was to evaluate the effects of laparoscopic hysterectomy versus abdominal hysterectomy in the abdominal trial and laparoscopic hysterectomy versus vaginal hysterectomy in the vaginal trial. We would like to congratulate the authors on having conducted two parallel randomized studies. Nevertheless, we disagree with their methodology. Indeed, there is major bias which unfortunately led the authors to the wrong conclusion. The primary endpoint of the trials was the occurrence of at least one major complication. In the study comparing abdominal hysterectomy and laparoscopic hysterectomy, the rate of major complications was as high as 11.1%. This rate is totally unacceptable and, in this context, I understand the authors' conclusion: "Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy". As previously mentioned, major bias could explain the differences encountered in complication rates: 1) First, 43 gynecologists from 30 different centres were enrolled in the study. The mean number of laparoscopic hysterectomies (n=584) per gynecologist was thus 13 over a period of four years. 2) The experience of the 43 gynecologists most certainly differed from centre to centre. This is not mentioned in the study. 3) To minimize potential effects due to the learning curve, each surgeon had to have performed each procedure at least 25 times. However, it is well known that the learning curve greatly exceeds 25 cases (2). In our department, an evaluation of major complications was made only after 1000 laparoscopic subtotal hysterectomies (Table I). The rate of major complications was found to be 0.6% and 2% after LASH and LH respectively. All but two of the complications occurred during the period from 1990 to 1995 (LASH : n=295; LH: 135) (3). If we analyze the period from 1996 to date, the rate of major complications after laparoscopic hysterectomy is exactly the same as that observed after abdominal hysterectomy. 4) Four different laparoscopic surgical approaches were used: laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopy- assisted vaginal hysterectomy and total laparoscopic hysterectomy. Again, this constitutes a serious bias. Differences in the rate of complications, depending on technique, have been described in the literature, especially during the learning curve (Table I). This should be pointed out in the manuscript. In summary, the conclusion reached by Garry et al (1) is not admissible because of considerable bias. Indeed, the unacceptably high complication rates are probably due more to the relative inexperience of surgeons in laparoscopic hysterectomy versus abdominal hysterectomy than the technique of laparoscopic hysterectomy itself. This prospective study should have analyzed the rate of complications according to the experience of each gynecologist. Table I Major complications LASH (n=1000) LH (n=600) Major haemorrhage 1* 2* Haematoma 0 2 Bowel injury 0 0 Ureteral injury 1 2 Bladder injury 3 3 Intraoperative conversion 1 1 Return to theatre 0 1 Total 6 (0.6%) 12 (2%) * Patients with preoperative Hb levels < 6 g/l received a transfusion the day before surgery. They are not included. References: 1. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. Br Med J 2004; 328 (7432): 129. 2. Wattiez A, Soriano D, Cohen SB, Nervo P, Canis M, Botchorishvili R et al. The learning curve of total laparoscopic hysterectomy: comparative analysis of 1647 cases. J Am Assoc Gynecol Laparosc 2002; 9: 339-345. 3. Donnez J, Nisolle M, Smets M, Polet R, Squifflet J. LASH: laparoscopic subtotal hysterectomy. In: An Atlas of Operative Laparoscopy and Hysteroscopy. Donnez J and Nisolle M (eds), Carnforth, Parthenon Publ 2001; pp. 243-250. J. Donnez, J. Squifflet, P. Jadoul, M. Smets
Competing interests: None declared |
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Larry R Glazerman, Clinical Assistant Professor, Obstetrics and Gynecology Lehith Valley Hospital, Allentown PA 18103
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I read with interest the recent publication of the eVALuate Trial published in the Journal. This was a well-designed randomized trial of laparoscopic, vaginal and abdominal hysterectomy. I take issue, however, with the conclusions of the study, specifically the inclusion of "unintended laparotomy" as a major complication. The authors' discussion of this issue is appreciated, but, in my opinion, this distinction adds an unacceptable bias to the study, as follows. The control group for the laparoscopic arm of the study was abdominal hysterectomy. Patients who were assigned to the abdominal group in either arm of the study, virutally by definition, could not have suffered this "complication," so comparing complication rates in the two groups is inappropriate and misleading. As suggested by the authors, elimination of this complication would have made laparoscopic and abdominal hysterectomies much more comparable. Competing interests: Consultant, Aesculap, Inc; Consultant, Inlet Medical, Inc; Medical Director IMET |
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Makarand K Oak, Consultant Obs & Gyn Hairmyres Hospital E Kilbride G75 8RG
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Editor, Ray et al (1) and Sculpher et al (2) have looked at outcome measures with three different approaches of hysterectomy but they have omitted the operation of sub-total hysterectomy. This procedure seemed to have been abandoned before cytological screening was accepted (3), because of the likelihood of stump carcinoma and inability to diagnose it early. However, with the success of cervical screening programme, this may not be a real risk, though women will have the inconvenience of regular smear checks. Furthermore cancer of the cervical stump would appear to be a rare occurrence (4). Removal of normal cervix may have adverse effect on bladder, bowel and sexual function (5). As the procedure reduces dissection in the region of the bladder and the vaginal vault, it also reduces operating time and is associated with reduced intra and postoperative morbidity. Preservation of the cervix will also preserve ligaments supporting the cervix and the vaginal vault thus reducing the possibility of vault prolapse. As a majority of the hysterectomies are performed for menorrhagia and uterine fibroids there is no clinical indication for removing an organ that is not the cause of the symptoms. Furthermore, in cases where there is significant distortion of the pelvic anatomy and the pathology is benign, it might be prudent to resort to subtotal hysterectomy. Finally, the procedure seems to be gaining popularity and a number of women undergoing hysterectomy are asking for sub-total hysterectomy. This operation is technically easy and shorter and the complication rate and length of stay may compare favourably with hysterectomy by other routes. In view of the above issues and equally importantly, due to consumer pressure, I believe there is a need for a properly conducted study to evaluate this procedure. Mr MK Oak
1. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328:129-133. 2. Sculpher M, Manca A, Abbott J, Fountain J, mason S, Garry R. Cost effective analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial. BMJ 2004;328:134-137. 3. Hasson HM. Cervical removal at hysterectomy for benign disease. Risks and benefits. J Reprod Med 1993;38(10):781-790. 4. Jones DE, Shackelford DP, Brame RG. Supracervical hysterectomy: back to the future? (comment). Am J Obstet Gynecol 2000;182(6):1648-1649. 5. Munro MG. Supracervical hysterectomy: a time for reappraisal. Obstet & Gynecol 1997;89(1):133-139. Competing interests: None declared |
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Thulasimani Munisamy, Medical Officer, Maternal and Child Health Division,Community Health Center Manadipet,Pondicherry-605 006,India, Ramaswamy Subramanian,Department of Pharmacology,Aarupadai Veedu Medical College,Kirumampakkam,Pondicherry-607 421, India
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More on the comparison of laparoscopic hysterectomy with conventional hysterectomy Editor – The study by Garry et al comparing laparoscopic hysterectomy with conventional hysterectomy is interesting1. We would like to add some more additional points on these lines. Hysterectomy is one of the commonest of all major surgical interventions. The mortality rate directly attributed to it ranges between 0.05% and 0.2%. There has been higher incidence of infection in the laparoscopic hysterectomy (both by abdominal and vaginal trial) and therefore prophylactic antibiotics are advocated for all laparoscopic hysterectomies2. No mention either about the mortality or prophylactic use of antibiotics was made which will be very useful. Yet, another parameter, i.e. uterine weight needs to be considered in such situations. An earlier study correlated the uterine weight and surgical duration and reported that blood loss as well as the operation time increase when the uterine weight increases; thus the uterine weight may be a parameter reflecting the difficulty of procedure3. Inclusion of these informations might add strength to the conclusion derived by authors. Besides, one of the common complication of laparoscopic hysterectomy is ureteric injury and has been recorded by the authors. Ureteric injury may cause considerable suffering when it occurs. Meticulous identification of the ureter by dissection and isolation is very time- consuming indeed. In those cases where ureteric anatomy is a cause for concern, the placing of transilluminating ureteric stents cystoscopically (which requires less than two minutes) may help to reduce the ureteric injury substantially2. From the provided data, it is not known whether the investigators have used such a technique. Hysterectomy by laparoscopic procedure has been shown to be associated with lower risk of pelvic adhesion formation and low morphine requirements compared to laparotomy procedure. Such informations may help to reduce patient sufferings. Last, but not least, the cost factor approximately ten times more in laparoscopic procedure deserves concern4. The suggestions made above, shall not only increase the strength of the article but also make the study more complete. Needless to say that inclusion of these data make the practitioner more informative. M.Thulasimani, M.D.
S.Ramaswamy, Ph.D.
1. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J et al. The eVALuate study: Two parallel randomized trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004; 328: 129-33. 2. John M. Complications of laparoscopic surgery. In: Phipps JH, ed. Laparoscopic hysterectomy and oophorectomy. Edinburgh: Churchill Livingstone 1993: 57-64. 3. Deprest JA, Cusumano PG, Donnez J, Hardy A, Nisolle M, Vanherendael BJ et al. 1992 results of the Belcohyst register on laparoscopic hysterectomy. In: Cusumano PG, Deprest JA, eds. Advanced Gynecologic Laparoscopy. London: The Parthenon Publishing Group 1996: 85-98. 4. Phipps JH. Clinical experience with laparoscopic hysterectomy and oophorectomy. In: Phipps JH, ed. Laparoscopic Hysterectomy and Oophorectomy. Edinburgh: Churchill Livingstone 1993: 65-68. Competing interests: None declared |
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Ashwini K Trehan, Consultant Minimal Access Gynaecologist Dewsbury & District Hospital, WF13 4HS
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I read the paper The eVALuate Study: two parallel randomised trial one comparing laparoscopic with abdominal hysterectomy the other comparing laparoscopic with vaginal hysterectomy (BMJ, Volume 328, 17th January 2004; Ray Garry et al) and cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial (BMJ Volume 328, 17th January 2004, Mark Sculpher et al) with much sadness as the author has not made any reference to the reasons for poor results and less cost effectiveness of LH (laparoscopic hysterectomy) as compared to TAH (abdominal hysterectomy) and VH (vaginal hysterectomy). Publications of such paper without reference to reasons could not only be damaging to the development of new techniques and services but would also interfere with the improvement of the healthcare systems. Thus I would request the readers (doctors and managers) of this paper to be cautious while reading and implementing in to their practice. In this study laparoscopic hysterectomy was associated with a clinically relevant higher incidence of major complications, took longer time than abdominal and vaginal hysterectomy and the cost effectiveness of LAVH compared with abdominal hysterectomy was more finely balanced and in comparison with vaginal hysterectomy is unlikely to be considered cost effectiveness How can one compare the complication rate of two types of procedure with no reference to the expertise with the procedure? Laparoscopic hysterectomy a relatively new procedure (1st laparoscopic hysterectomy 1989) has been compared with a 150 year old procedure (1st standard TAH 1878). Abdominal hysterectomy (TAH) has gone through several refinements over the years and has well written accepted technique and protocols. Laparoscopic hysterectomy has not been subjected to similar refinements nor has any agreed technique or protocol. Some would only take upper pedicle (round ligament and FT), some would reflect the bladder, some would also take uterine artery and finally a few would complete hysterectomy laparoscopically. A few use disposable instruments others use reusable. There is also diversity of the method to detach uterus from its attachment, it could be coagulation of pedicle, use of metal clips or ligature. Thus it is evident that laparoscopic hysterectomy has no set agreed technique and is going through the evaluation phase. Secondly 43 gynaecologists who took part in this study did not have similar experience for laparoscopic hysterectomy as they had for abdominal hysterectomy. I believe the surgeons only needed experience of 20-25 laparoscopic hysterectomies to recruit patients in this study and the learning curve of most involved was see one, assist one and do the next one. All of these surgeons had gone through several years of experience of abdominal hysterectomy. They had read about abdominal hysterectomy as a student, seen it being done as H.O (house officer); assisted as senior house officer; performed with senior assisting as registrar; undertook independently as senior registrar with consultant available if necessary and finally continued to practice of TAH as consultant for several years. How can we justify comparing a well-mastered technique (TAH) with a technique (LH) with so little experience? It is not surprising that the LH in this study was associated with significantly higher rate of complications. There are papers in literature where some of the author’s1 have published safety and low complication rate (4.5%) of LH even though the pathologies were more than severe and abnormal (73.4%) as compared to eVALuate Study (27%). (73%of hysterectomies in Evaluate Study was done for DUB-dysfunctional uterine bleeding). This may indicate that if exposed to similar training and experience as TAH with agreed technique LH is likely to have lower complications. Laparoscopic hysterectomy in eVALuate Study took 33 minutes (72 minutes V-39 minutes) longer than the vaginal hysterectomy but it detected 4 times more pathologies (16.4% V-4.8%). It should be taken in positive sense if more pathologies can be detected and dealt with to prevent future operations and operating time. Moreover as mentioned above it is it not unusual for a new technique in developmental phase to take more time. In the publication Hysterectomy towards an Overnight Stay1 two main factors largely contributed to longer operating time, which were the adjunctive procedures (63.4%) and laparoscopic checking of the vault and coagulating bleeding points (38%). The extra few minutes needed for LH allows complete removal of pathological lesions, which produces minimal complications and avoids re-operation at a later date. Extra theatre cost due to extra theatre time is fully justified if better outcome is achieved. I am sure all will agree we should strive for better quality. In the eVALuate Study 63% (874/1380 cases) of patients had hysterectomy for DUB. This practice would be questioned in the present era with call for more conservative management of menorrhagia with easy availability of Mirena IUCD and transcervical endometrial ablation techniques. Thus the only reason for hysterectomy for benign gynaecological reasons are pelvic pain (endometriosis, adenomyosis, adhesions, ovarian and uterine fixity, pelvic inflammatory disease) enlarged uterus due to fibroid not uncommonly associated with endometriosis and failed ablation due to continued pain or bleeding. In eVALuate study these conditions were the reason for only 37% of hysterectomy the rest were for DUB. Can we justify to do blind vaginal hysterectomy for the above conditions without removing/dealing with actual cause for the pelvic pain? We cannot set double standards and argue in the favour of hysteroscopy – see and diagnose/treat but when it comes to hysterectomy, a major undertaking we recommend a blind vaginal hysterectomy especially when we all accept that hysterectomy may only be necessary for the above mentioned conditions. I would also argue the conclusion “laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy and its cost effectiveness relative to the abdominal procedure is finely balanced”. The reason for this conclusion is also due to lack of operator experience resulting in high complications, which cost money and also minimal advantage in terms of hospital bed saving (LH-3.95 V-abdominal 5.11 days) in the study. But if complication rates and hospital stay can be reduced towards those reported in the publication “Hysterectomy towards Overnight Stay” 1 (4.5% mostly minor and 1.08 days) there would be enormous savings. Finally I would wish to urge those responsible for training to ensure that LH is in the curriculum of junior gynaecologists and agree on the operation technique, instruments and protocols to offer our women a service fit for 21st Century. Laparoscope is a gynaecologists instrument with enormous potential and it would be sad to loose it in the hands of surgeons because of publication of such studies without reference to the reasons for the poor outcome. 1. Mr A K Trehan. Hysterectomy Towards an Overnight Stay. Gynaecological Endoscopy 2002, 11, 181-187. Competing interests: None declared |
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Ivo A. Brosens, Emeritus professor B-3000 Leuven, Belgium
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Editor - In his discussion on laparoscopic hysterectomy Garry et al1 seem to conclude that we need more centres of laparoscopic excellence with “super” surgeons to perform properly the most common gynaecological surgical procedure by laparoscopy. While the study was intended to compare the routine practice of laparoscopic hysterectomy a major bias of in the study was that all surgeons were properly trained during their residency in abdominal and vaginal hysterectomy, but not all in endoscopic surgery. This lack of endoscopic training is reflected by the poor selection of patients for laparoscopic hysterectomy as manifested by the high rate of conversion to abdominal or vaginal hysterectomy. Apparently some surgeons knew how to operate, but not when they were not able to operate laparoscopically. The years of experience needed to learn when not to operate laparoscopically should preferably occur during the residency. We therefore may need not more centres of excellence with “super” surgeons, but a full training program in endoscopic surgery during residency. 1. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J, et al. The eVALuate study: two parallel randomized trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328: 129-36. Competing interests: None declared |
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Adrian Lower, Consultant Gynaecologist 136 Harley Street, London, W1G 7JZ, Robert Hawthorn
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We were interested to read the articles by Garry et al.(1) and Sculpher et al.(2) comparing laparoscopic hysterectomy with conventional abdominal and vaginal procedures. We also read with interest the responses that these articles engendered. The authors, however, draw little attention to intra-abdominal adhesions in terms of either their effects on patient outcomes and the complexity/successful performance of these procedures, or the risks of de novo adhesion formation associated with each intervention. We noted with interest the response by Munisamy and Subramanian, in which they referred to the lower risks of pelvic adhesion formation following laparoscopic hysterectomies. Intra-abdominal adhesions occur in 60–90% of patients who have undergone gynaecological surgery, account for up to 40% of cases of female secondary infertility and are associated with chronic pelvic pain in many women.(3) They also impose a considerable burden on healthcare resources in terms of hospital readmissions and re-operations.(4) A large proportion (58–63%) of patients in the study arms of both eVALuate trials had undergone previous abdominal surgery and were therefore likely to have pre-existing intra-abdominal adhesions. Indeed, adhesions were one of the main additional pathological findings in all four study arms. As a result, the presence of adhesions is likely to have increased the risks of peri- and post-procedural complications and hindered the ability of surgeons to perform the procedures – particularly laparoscopies – successfully. The authors state that abdominal hysterectomies were associated with longer recovery times, impaired patient quality of life and body image, and higher costs than laparoscopies. We disagree with the assertion by Munisamy and Subramanian that laparoscopies are associated with lower risks of adhesion formation than laparotomies. In our own work in the recent SCAR-2§ study,(5) we observed substantial hospital readmission rates for adhesion-related complications following certain laparoscopic procedures (e.g. drainage of ovarian cysts and division of peritoneal adhesions). We do believe, however, that these data highlight the importance of using good surgical techniques, minimally invasive procedures and adhesion-prevention agents in order to reduce the risk of adhesion formation. By these means, complications and surgical costs may be minimised and patient quality of life safeguarded. We believe that further analyses investigating the impact of adhesions on the complexity/success of these interventions would provide useful information with which to evaluate the relative merits of each procedure. §SCAR, Surgical and Clinical Adhesions Research. References 1. Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328:129. 2. Sculpher M, Manca A, Abbott J, Fountain J, Mason S, Garry R. Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial. BMJ 2004;328:134. 3. Liakakos T, Thomakos N, Fine PM, Dervenis C, Young RL. Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Recent advances in prevention and management. Dig Surg 2001;18:260–73. 4. Lower AM, Hawthorn RJ, Ellis H, Brien F, Buchan S, Crowe AM. The impact of adhesions on hospital readmissions over ten years after 8849 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. BJOG 2000;107:855–62. 5. Lower A, Hawthorn RJS, Clark D, Knight AD, Crowe AM. Adhesion- related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients. Hum Reprod 2004 (in press). Competing interests: Adrian Lower has been involved in adhesions research for over 10 years. During this time he has been in receipt of research funding from Ethicon, Gynecare, Genzyme and Shire Pharmaceuticals. He has received honoraria from Ethicon, Gynecare, Genzyme, Shire Pharmaceuticals, Confluent Surgical Inc, and ML Laboratories for attendance at meetings and participation in workshops on studies and adhesion-prevention products. Hawthorn has been involved in adhesions research for over 10 years and has received honoraria from Genzyme, Shire Pharmaceuticals and ML Laboratories for attendance at meetings and participation in workshops on studies and adhesion-prevention products. |
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Roger A. McMaster-Fay, Clinical Lecturer University of Sydney, c/ PO Box 82 Emu Plains NSW 2750, Australia
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The eVALuate study1,2 had a ‘vaginal arm’ (vaginal hysterectomy [VH] -v- laparoscopic hysterectomy [LH]) and an ‘abdominal arm’ (abdominal hysterectomy [AH] -v- LH). “The gynaecologist allocated the patients to either the abdominal or vaginal trial according to preferred clinical grounds”.2 Clinically this would most likely mean that the ‘easier’ cases would be performed in the vaginal trial and the more difficult cases, who would not be suitable for VH, would be performed in the abdominal trial. But in the LH arm of the ‘abdominal trial’ “most of the procedures were of LAVH (laparoscopically-assisted vaginal hysterectomy) type”,2 thus most of the patients the ‘abdominal trial’ (i.e. not suitable for the ‘vaginal trial’) and randomised to the LH arm had laparoscopically-assisted vaginal hysterectomies. This indicates that the surgeons involved had little experience at LH. Subsequently there were five ureteric injuries (0.86%) in the LH arm of the ‘abdominal trial’. Our recently published article3 presents data that indicates that ureteric injury at LH is more the result of surgical inexperience and that in experienced hands the rate of ureteric injury is probably no higher than for AH. The stapling of the uterine vascular pedicles resulted in the injury of four ureters in the first 275 cases (1.45%), whereas in the subsequent 1,000 cases there was only one such injury (0.10%). Wattiez et al.4 (using bipolar cautery) had significantly more renal tract injuries in their first 695 laparoscopic hysterectomies than in the subsequent 952, with ureteric injuries falling by almost two thirds from 0.58% to 0.21%. These latter results compare favourably with the reported rates in AH3 and with the rate (corrected) of 0.39% for the AH’s performed in the trials reported in the recent meta-analysis.5 We suggest that in experienced hands and with a perfected technique the ureteric injury rate is no higher for LH than for AH. 1. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328:129-33. 2. Garry R, Fountain J, Brown J, Manca A, Mason S, Sculpher M et al. EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technology Assessment 2004;8:No.26. 3. McMaster-Fay RA, Jones RA. Laparoscopic hysterectomy and ureteric injuries: a comparison of the initial 275 and last 1,000 cases using staples. Gynecological Surgery 2006;in press. 4. Wattiez A, Soriano D, Cohen SB et al (2002) The learning curve of total laparoscopic hysterectomy: comparative analysis of 1647 cases. J Am Assoc Gynecol Laparosc 9:339-345. 5. Johnson N, Barlow D, Lethaby A, Tavender E, Curr L, Gary R. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ 2005:330;1478-81. Competing interests: None declared |
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