- Christian Kremer, research registrar,
- Sean Duffy, senior lecturer (, )
- Michelle Moroney, consultant
- Correspondence to: S Duffy
- Accepted 24 September 1999
Objective: To compare outpatient hysteroscopy with day case hysteroscopy in terms of patient satisfaction and acceptability
Setting: Gynaecology clinic of a teaching hospital.
Participants: 100 women.
Design and interventions: Patients were randomly allocated to outpatient hysteroscopy or day case hysteroscopy provided they had no preference for either procedure.
Main outcome measures: Satisfaction rate, requirements for postoperative analgesia, speed of recovery, time away from home, and time off work
Results: The outpatient group recovered preoperative fitness more quickly than the day case group (2 days (range 1-2.7) versus 3 days (2–4), P<0.05). After the procedure, the outpatient group were also fully mobile more quickly than the day case group (0 minutes (0–5) versus 105 minutes (80–120), P<0.001). Requirements for postoperative analgesia were similar in both groups. Overall, 78% of patients considered that the pain from outpatient hysteroscopy was less than that usually experienced during menstruation. Patient satisfaction was similar in both groups (83.6% in the outpatient group versus 77.0% in the day case group).
Conclusions: Outpatient hysteroscopy and day case hysteroscopy were equally acceptable to patients. Patients recovered significantly more quickly from outpatient hysteroscopy than from day case hysteroscopy.
Patients' satisfaction rates with outpatient hysteroscopy and day case hysteroscopy were similar
The outpatient group recovered preoperative fitness more quickly than the day case group
Requirements for postoperative analgesia were similar in both groups
78% of patients considered that the pain from outpatient hysteroscopy was less than that usually experienced during menstruation
Postmenopausal women may benefit less from outpatient hysteroscopy than premenopausal women
Editorial by Naftalin and Habibu
Abnormal uterine bleeding is the second most common gynaecological symptom. Hysteroscopy combined with endometrial biopsy has almost replaced dilatation and curettage for the investigation of this symptom.1 Most hysteroscopies are performed under general anaesthetic despite evidence suggesting it is a well tolerated and acceptable outpatient procedure. 2 3 We describe the first randomised controlled trial of outpatient hysteroscopy versus day case hysteroscopy. We hypothesised that satisfaction rates with the whole process would be similar in the outpatient and day case arms of the study.
Participants and methods
Our study was approved by the local ethics committee. One hundred patients were recruited at the gynaecology clinic of a teaching hospital. The inclusion criteria were bleeding from the vagina requiring investigation (menorrhagia, intermenstrual bleeding, and postmenopausal bleeding). We excluded patients who were unfit for day case surgery and those who preferred either outpatient hysteroscopy or day case hysteroscopy. In total, 454 patients were invited to participate in the study: 235 (52%) and 118 (26%) patients opted for outpatient and day case hysteroscopy respectively. One hundred patients (22%) agreed to participate. Each was randomly allocated at the gynaecology outpatient clinic to one of the two investigations. Randomisation was achieved with sealed envelopes containing computer generated block randomisation numbers. Randomisation and recruitment to the study were carried out independently of the clinician who later performed the hysteroscopy and the person who performed the outcome assessments.
We reviewed 100 patients for analysis. Three patients failed to return follow up questionnaires (table 1). None of the 100 patients had had an outpatient hysteroscopy. Sixteen women (32%) in the outpatient group and 14 (28%) in the day case group had had day case hysteroscopy. Each patient was also asked to complete a hospital anxiety and depression scale questionnaire.4
Outpatient hysteroscopy was performed with a 3.6 mm semiflexible hysteroscope (HYF-P, Keymed Olympus, Southend) and without anaesthesia. Cervical dilatation up to Hegar number 4 was carried out when deemed necessary. Any endometrial polyps were resected under general anaesthesia at a later date. When the endometrium looked abnormal sampling was performed with a Pipelle device (Laboratoire CCD, Paris).5 Immediately after the investigation the patient was asked to quantify the pain experienced during hysteroscopy. Analgesia was provided if required. Patients were allowed home when they felt ready.
Day case hysteroscopy was performed with a standard 5 mm rigid hysteroscope (Keymed Olympus, Southend). Cervical dilatation before hysteroscopy was performed when required. Endometrial curettings were obtained after each procedure. Each patient was informed about the findings at hysteroscopy after the operating list. Once the patient was fully mobile she was allowed home. Time away from home and time off work were recorded for each patient.
In all other aspects these two procedures were clinically similar. Carbon dioxide was the distension medium. Navigation of the cervix was carefully performed to prevent any false passage or bleeding from the cervix. A panoramic view of the uterine cavity was obtained followed by inspection of both cornua. Finally, the carbon dioxide was released to facilitate endometrial sampling.
Assessment of recovery
Recovery was assessed 30 minutes after the procedure with a modified Steward scale (scale 0-12), 6 7 which included an appreciation of the extent of consciousness, the quality of the airway, the level of activity, and the presence of nausea or vomiting. A Likert scale (scale 0-10) was used to assess the extent of pain experienced on return to the ward in the day case group and on return home in the outpatient group.8
Each patient was given a diary to record analgesia requirements and fitness after discharge. Duration of recovery was recorded together with satisfaction with the procedure one week after discharge. Satisfaction with the procedure, the main outcome measure, was assessed by asking patients what type of hysteroscopy they would choose if investigation was required again
Statistical significance was assessed by the Mann Whitney test, χ2 test, Fisher's exact test, and unpaired t test. When non-parametric tests and χ2 tests or Fisher's exact tests were used interquartile ranges and 95% confidence intervals of the difference between proportions are given respectively.
Fifty patients were randomised to each procedure. Both groups were homogeneous for demographic data, anxiety levels, and risk factors for difficult hysteroscopy (table2)
Two outpatient procedures failed (4%, 95% confidence interval 0% to 9%); one because of cervical stenosis and the other at the patient's request because of pelvic discomfort. Cervical dilatation was necessary in 11 patients in the outpatient group (22%, 10% to 33%).
No difference was found in patient satisfaction rate between outpatient hysteroscopy and day case hysteroscopy (table 3). In the outpatient group, 13 (81%, 61% to 100%) of those patients who had had hysteroscopy under general anaesthesia would opt for outpatient hysteroscopy again. Endometrial sampling was performed in 31 patients (62%) in the outpatient group. No significant difference in satisfaction rates was found between the patients in whom endometrial sampling was carried out and those in whom it was not (80.6% versus 88.8%, −11.6% to 28%).
All patients who had undergone outpatient hysteroscopy scored the maximal mark on the modified Steward scale (12/12) indicating full recovery at 30 minutes. Seven out of 46 patients (14%) in the day case group scored less than 12, mainly because of postoperative nausea or vomiting. Two other patients were unable to communicate within 30 minutes of the procedure. Patients in the day case group took significantly longer to recover full mobility and full fitness than those in the outpatient group. Forty patients (80%) in the outpatient group were fully mobile immediately after the procedure. Women in the outpatient group spent significantly less time away from home and less time off work than those in the day case group. Requirements for postoperative analgesia were similar in both groups (table 3). Table 4 shows the intraoperative pain levels for the outpatient group.
Factors associated with reduced patient satisfaction
Pain and the need for cervical dilatation during the procedure were associated with a reduced level of satisfaction in the outpatient group. There was a trend towards a lower satisfaction rate in postmenopausal patients (table5). Patients who required a repeat procedure (10 of 49, 20%) were less satisfied than those who did not (60% (6 of 10) versus 89% (35 of 39) respectively, −61% to 2%). No association was found between the level of preoperative anxiety, the use of analgesia, and the satisfaction rate.
Reduced patient satisfaction in the day case group was associated with prolonged recovery of preoperative fitness (3 days (range 1-3) in satisfied patients versus 4 days (4–6) in unsatisfied patients, P<0.01). There was also a trend towards a lower satisfaction rate in postmenopausal patients than in premenopausal patients (table 5).
Outpatient investigation of abnormal uterine bleeding is a comparatively new concept in gynaecology. Whereas endoscopy is accepted as an outpatient procedure in gastrointestinal medicine, the same is not true in gynaecology. There are potential advantages to an outpatient approach to investigation, least of which is the ability for direct access to services by general practitioners. We present the first randomised controlled trial of a strategy for outpatient investigation of women with abnormal uterine bleeding. Our trial compared traditional day case hysteroscopy, using general anaesthesia, with the novel outpatient approach.
Patient satisfaction and recovery
We set out to determine the differences in recovery and acceptability between the two procedures, concentrating on the whole process and not merely the technique of hysteroscopy. We found that outpatient hysteroscopy was associated with equal patient satisfaction to day case hysteroscopy. From the patients' and the healthcare provider's perspective outpatient hysteroscopy is likely to be more convenient than day case hysteroscopy as it is quicker and avoids undue hospital stay. Outpatient hysteroscopy was better than day case hysteroscopy for all aspects of patient recovery. This has important social implications for patients and employers: time off work, childcare arrangements, and cost implications in particular (patient, employer, and service provider). These issues will be addressed in a subsequent publication.
Factors associated with patient satisfaction
Failure to gain access to the uterine cavity has been a concern in outpatient hysteroscopy. Failure rates range from 1.5%9 to 9%.10 The failure rate in our study was 4%. A satisfaction rate of 97% had been reported in a previous cohort study 11 12 despite a 6% failure rate and a mean visual analogue score of 3.25.11 The inference is that patients tolerate acceptable failure and discomfort and still remain satisfied.
In our study the need for a repeat procedure after an endometrial polyp had been diagnosed was also associated with a lower satisfaction rate. Reducing this need by removing the polyp in the outpatient department may improve patient satisfaction but would prolong the procedure.
Patients may favour outpatient hysteroscopy because they spend less time in hospital. They may also perceive their care as being more personalised. Indeed, each patient is counselled, investigated, and finally informed of the findings, in sequence. In addition, the patient can observe the procedure on a television monitor thereby perhaps enhancing understanding of her condition.
We used two different types of hysteroscopes, which differed by 1.4 mm in diameter. This difference was not thought to influence patient satisfaction with the overall investigative process. This assumption is supported by the similar and low pain scores in both groups shortly after the procedure.
Only 21% of the eligible patients agreed to participate in our study. When patients were initally approached one quarter decided to opt for a day case procedure in the belief that this was the conventional procedure. Half of the patients opted for an outpatient procedure because of its perceived convenience. In undecided patients, the satisfaction rate with either of the procedures was similar. It would seem therefore that for most women outpatient hysteroscopy is a satisfactory alternative to day case hysteroscopy.
The perceived benefits of outpatient hysteroscopy may not apply equally to premenopausal and postmenopausal patients. Our study was not large enough to detect a significant difference in satisfaction rates between these two subgroups. Interestingly, the same difference in satisfaction rates between premenopausal and postmenopausal women was seen in both the day case group and the outpatient group
Recovery and requirements for analgesia were the main clinical outcomes addressed in our study. The comparison of aspects such as diagnostic value and morbidity can not be assessed in a study of this size. Our results provide an interesting preliminary finding that should lead to a much larger randomised study addressing these other important clinical issues. Data from large cohort studies suggest that outpatient hysteroscopy is just as safe as hysteroscopy under general anaesthesia3 13
Despite the well documented advantages of outpatient hysteroscopy there is a perceived reluctance to implement this type of service. There may be concerns about patient discomfort and acceptance. This procedure is thought to provoke anxiety in patients, thus influencing satisfaction. The present study does not support these concerns.
Patients are not disadvantaged by the introduction of outpatient hysteroscopy. Several advantages may prove attractive to patients and healthcare providers: return to mobility, full fitness, and work occur more quickly after outpatient hysteroscopy than after day case hysteroscopy. Increased attention should be paid during counselling of patients at higher risk of dissatisfaction with hysteroscopy, such as postmenopausal patients. The development of outpatient hysteroscopy is a potentially significant advance in gynaecological investigation. It lends itself to a greater accessibility for general practitioners and patients, especially if a direct referral service from a general practitioner is contemplated.
Contributors MA and SD conceived and designed the study. CK performed all the procedures and collected and analysed the data. CK and SD wrote the paper. SD will act as guarantor for the paper.
Competing interests None declared.
website extra The sample size calculation appears on the BMJ's website www.bmj.com