Hysteroscopic sterilisation: a study of women's attitudes to a novel procedure
Mr S. Duffy, University Department of Obstetrics and Gynaecology, Level 9 Gledhow Wing, St James's University Hospital, Beckett Street, Leeds, Yorkshire, UK.
Laparoscopy is the most common mode of surgery for female tubal sterilisation. Hysteroscopic sterilisation is a new method which can be performed in the outpatient setting under local anaesthetic. We carried out a prospective cohort trial to determine whether women would actually favour hysteroscopic sterilisation over laparoscopic sterilisation. Data analysis in a cohort of 96 women showed that 77% would prefer laparoscopic sterilisation over the hysteroscopic procedure (23%), despite the advantages of an outpatient setting. Age, obstetric history, employment and marital status, access to transport and previous anaesthetic did not significantly influence the choice made.
Laparoscopy is the most common mode of surgery for female tubal sterilisation. When counselling a patient about laparoscopic sterilisation, it is possible to quote published data which have been confirmed worldwide. When compared with an open procedure laparoscopic sterilisation is associated with reduced morbidity and mortality, a quicker recovery time and reduced hospital costs. However, it still carries operative risks of bowel damage and haemorrhage as well as failure of contraception, and all patients should be made aware of these possibilities. In addition, a general anaesthetic is usually required.
In its plan issued for the NHS, the Department of Health aims to reduce inpatient waiting lists and recovery times by transferring many surgical procedures to the outpatient setting.1 The move of some gynaecological surgical investigations to outpatient clinics should result in a more efficient use of hospital services and less burden on the patient. Kremer et al.2 compared inpatient and outpatient diagnostic hysteroscopy and found that there was a quicker return to mobility and pre-operative activity in the outpatient group. It has also been shown that there is higher patient satisfaction with the outpatient procedure compared with the one requiring general anaesthetic.3 The Department of Health plan states that the patient should be more fully involved in any decisions made about his or her care. Therefore, in any situation where a procedure can be performed both in an operating theatre or an outpatient clinic, patient preference should be a strong consideration.
Hysteroscopic sterilisation is a new method which is currently being assessed under trial conditions. It can be performed in the outpatient setting under local anaesthetic, avoiding the need for general anaesthesia and allowing the patient to watch the procedure. It involves the bilateral placement of a coiled micro-insert into the proximal section of the fallopian tube, under hysteroscopic visualisation.4 The device induces an inflammatory process and over a period of approximately three months, the local in-growth of fibrous tissue led to occlusion of the fallopian tubes. Insertion of the devices is quick with the majority of cases taking under 11 minutes.5 The patient can go home within minutes of the procedure. Non-randomised trials of hysteroscopic sterilisation have found it to be a highly acceptable procedure to patients6 with excellent contraceptive effect. However, the follow up time is limited to two years and there is as yet no long term data available.
One would assume that women requesting sterilisation would similarly prefer to have it performed in the outpatient setting if possible, especially those wanting a speedy recovery and a rapid return to normal activities. We carried out this prospective cohort trial to determine which route women would actually favour, laparoscopic sterilisation or hysteroscopic sterilisation, if given the choice. The study was designed to look primarily at patient attitudes to a new procedure and also to assess the feasibility of undertaking a subsequent randomised controlled trial to compare laparoscopic sterilisation and hysteroscopic sterilisation, as the two procedures have not yet been directly compared.
One hundred consecutive women of reproductive age awaiting routine appointments in the gynaecology outpatient clinic at St James's University Hospital, Leeds between February and April 2001 were approached to take part in the study. We presented them with written information about both laparoscopic and hysteroscopic sterilisation. The information leaflets were designed by one of the departmental researchers and included the advantages and risks of both procedures. All the information was assessed independently for accuracy and fairness by a panel of specialists. After reading the material, the women were asked to fill in a questionnaire, stating their theoretical choice and giving their reasons from a specified list of attributes devised from a number of other previous studies assessing outpatient procedures (see Table 1). Patient demographics were recorded and a brief medical history was taken, especially targeted at previous hospital experiences.
Table 1. Reasons for choosing laparoscopic or hysteroscopic sterilisation.
|Chose laparoscopic sterilisation (n= 54)|
|Wants to be asleep||52|
|Does not want ‘coils’ in their uterus||34|
|Wants it to be effective immediately||31|
|Does not want to watch the procedure||24|
|Would be embarrassed to be awake||15|
|Does not want to use contraception for three months||15|
|Does not want a ‘new’ procedure||10|
|Does not want a follow up X-ray||8|
|Chose hysteroscopic sterilisation (n= 16)|
|Wants a quicker recovery time||24|
|Likes the idea of a quick outpatient visit||20|
|Does not want any incisions or scars||18|
|Does not want an anaesthetic||14|
|Does not want to stay in hospital for the day||12|
|Does not want the risks of laparoscopy||11|
|Does not want an ‘injection’ for the anaesthetic||9|
|Difficulty with childcare arrangements||6|
|Does not want to be fasted||3|
The participants were all asked to give an informed choice from the following: (1) laparoscopic sterilisation, (2) hysteroscopic sterilisation, (3) require more information before making a decision or (4) no particular preference and happy to be randomised to either route.
The data from the completed questionnaires were entered into a Microsoft Excel spreadsheet and statistical analysis was performed using Student's t test and the χ2 test to look at the influence of various factors on the choice made.
Complete data were obtained on 96 women (96%). All women were between the ages of 17 and 69 years with an average age of 38 years. Based on the information they were given, 70 women (73%) expressed a definite preference for laparoscopic sterilisation or hysteroscopic sterilisation. Eighteen women (19%) felt that the information leaflets were not detailed enough and requested more information. Only eight patients (8%) were in equipoise and therefore willing to be randomised.
Of the 70 women who made a choice, 54 (77%) preferred to have the procedure carried out by laparoscopy and 16 (23%) by hysteroscopy. The attributes chosen to define preference for either laparoscopic or hysteroscopic sterilisation are shown in Table 1. The main attribute for the laparoscopic route was the desire to be asleep, and for the hysteroscopic sterilisation, the main attribute was the quick recovery period. The investigators did not explore the laparoscopy group further to establish whether by offering hysteroscopic sterilisation under general anaesthetic, their choice would change.
The data were analysed with regard to age, marital status, employment, parity, transport and previous anaesthetic experience to see whether any of these factors influenced the attributes chosen. The factors were compared between the groups of laparoscopic sterilisation, hysteroscopic sterilisation and those in equipoise. The women who requested more information were not included in the analysis. No significant factor seemed to influence the choice from the parameters measured.
For any new surgical procedure, the ideal assessment of effectiveness and patient acceptability would be a randomised controlled trial to compare it with an established technique. The cohort of patients suitable to take part in such a study would be those who do not have a definite preference for the established operation, so that they can be randomised to either arm (i.e. those in equipoise). We approached 100 women requesting permanent contraception over a period of eight weeks and of these only eight would have been willing to enter a trial where the route of sterilisation would be chosen randomly. If we presume that 200 women would need to take part in a randomised controlled trial to compare laparoscopic sterilisation and hysteroscopic sterilisation to achieve statistical power based on patient satisfaction as a primary outcome, it would take approximately four years in a single unit for the recruitment phase. With such an extended accrual period, a randomised controlled trial is therefore not a feasible option to investigate the differences.
Although we often assume that most women would prefer an outpatient procedure compared with one performed under a general anaesthetic, this has not proved to be the case in this study. Surprisingly, of the women who expressed a definite preference for laparoscopic sterilisation or hysteroscopic sterilisation, the majority preferred the laparoscopic procedure under a general anaesthetic to the hysteroscopic one as an outpatient. There are various reasons for a woman's preferred choice of procedure and these must all be considered by the clinician during counselling. Many factors thought to influence patients' preferences may actually be insignificant. This study shows that if a woman wishes to undergo sterilisation, the choice of route is not affected by her age, marital status, parity, employment status or transport access or previous anaesthetic experience. We had expected to see a higher proportion of women with jobs or young children at home to choose hysteroscopic sterilisation as this would mean a shorter stay in hospital, a quicker recovery and return to everyday activities, but this was not the case. We also felt that previous obstetric experiences would heavily influence the choice but again this wasn't so.
As hysteroscopic sterilisation is a new procedure that is still being performed under strict trial conditions, there is a paucity of data about it. This must be taken into consideration when asking women to make a choice. Contrastingly, many women worldwide have undergone laparoscopic sterilisation to date. Therefore, there is a wealth of experience with this operation and most of those requesting permanent contraception will know someone who has had laparoscopic sterilisation. This automatically leads to bias. We also accept that there was an built-in bias in the information leaflets as we were unable to offer any subjective comparisons between laparoscopic sterilisation and hysteroscopic sterilisation.
The main reason for preferring laparoscopic sterilisation was the desire to be asleep for the procedure. Therefore, by offering a choice about the method of anaesthesia, there may be a higher uptake into the hysteroscopic sterilisation group. However, this would then involve loss of the cost benefits of an outpatient procedure. The choice of a general anaesthetic suggests a lack of understanding of hysteroscopic sterilisation, with an assumption that it will be painfully intolerable, as well as an under-estimation of the risks of anaesthesia. More information on the acceptability of an outpatient procedure may therefore prove useful in influencing patient choice.
In summary, hysteroscopic sterilisation has been shown to be acceptable in the outpatient setting in previous trials. However, in a random cohort of women with a preferred route of sterilisation, 77% chose the laparoscopic procedure over the hysteroscopic (23%), primarily because of the wish to be asleep. Age, obstetric history, employment and marital status, access to transport and previous anaesthetics were not significantly influential on the choice made. A randomised controlled trial to compare laparoscopic sterilisation with hysteroscopic sterilisation would not be feasible but further cohort studies of hysteroscopic sterilisation are recommended.