Feasibility of a Randomised Controlled Trial of Laparoscopic Hysterectomy Versus Laparoscopic Sub-Total Hysterectomy

Hysterectomy remains the last resort for a number of benign conditions which have failed to respond to conservative measures. Hysterectomy is also performed for operable gynaecological malignancy which is excluded from the present study. Conventional techniques for uterine extirpation involve open surgery through an abdominal or vaginal incision. In the laparoscopic approach small incisions are made in the abdomen to allow insertion of a laparoscope and operative instruments. In Laparoscopic Sub-total Hysterectomy (LSH) the entire procedure is performed laparoscopically, the cervix is left in situ and the specimen is removed through an abdominal port (See Appendix I for classification of laparoscopic hysterectomy). In Laparoscopic Hysterectomy (LH) part of the operation is performed laparoscopically, up to and including division of the uterine vessels, but the specimen is removed with the cervix through an open vaginal vault. (See Appendix II for detailed description of equipment and technique).

Popularity of hysterectomy shows a geographical distribution from a high of 5.4 per thousand women in the USA (Farquhar 2002) to a nadir of 1.2/1000 in Norway (Backe et al 1993). Despite the high prevalence, how and in whom hysterectomy should be undertaken remains controversial. A Cochrane systematic review of methods of hysterectomy concluded that fewest complications occur with vaginal hysterectomy (VH) whereas abdominal hysterectomy (AH) carries the highest risk (Johnson et al 2006). The meta-analysis included 27 RCTs with a total of 3643 participants comparing one surgical approach of hysterectomy to another. The authors concluded that VH should be the approach of choice for benign indications as it is a fast, relatively cheap technique with rapid recovery and a low complication rate. LH should be offered when VH is not practicable. Despite this grade 1 evidence most hysterectomies worldwide are performed as total abdominal hysterectomies (TAH) when the whole uterus with attached cervix is removed through an abdominal incision (Garry 2005).

Prior to the introduction of population cervical screening it remained routine practice to remove the non-diseased cervix at the time of hysterectomy to prevent cancer of the cervical stump (Munro 1997). Total hysterectomy (TH) was therefore standard and sub-total hysterectomy (STH) was usually reserved for those rare clinical circumstances when removal of the cervix was deemed unduly difficult or risky for the patient. A number of retrospective studies have shown reduced operating time, reduced ureteric complications and reduced blood loss with STH (Kilkku et al 1983, Kilkku 1985, Brown et al 2000, Lalos and Bjerle1986). It has been postulated that TH leads to more extensive disruption of pelvic innervation than STH with accompanied increased risk of poor bladder, bowel and sexual function. However, RCTs have failed to confirm this hypothesis (Thakar et al 2002, Gimbel et al 2003). Indeed a recent Cochrane systematic review has shown no difference in the rates of continence, constipation or measures of sexual function between STH and TH (Lethaby 2006). Why findings of the RCTs do not match observational data is unclear. Perhaps the tools used for assessment of the outcome measures studied are not sufficiently sensitive or have been applied too infrequently to detect a clinically important difference.

Total laparoscopic hysterectomy (TLH) was introduced by Harry Reich (Reich et al 1989) and was modified into laparoscopic assisted vaginal hysterectomy (LAVH) with a sub-total variation, LSH, introduced by the minimal access pioneer Kurt Semm in 1991 (Mettler et al 1997). Only 1 randomised comparison on the subject has been published (Morreli et al 2007) with no significant differences found on comparison of LSH and TLH with respect to complications or post-operative recovery.

Case series suggest recovery from LSH occurs much earlier with return to normal quoted from within 3-21 days (Lyons 1997, Jugnet et al 2001, Schwartz 1994, Zupi et al 2003 and Donnez & Nisolle 1993). It follows that in order to detect a difference in recovery between the 2 treatment groups frequent assessments are necessary during the first 12 weeks following surgery. Post-operative recovery will be assessed in participants of the current study at 6 hours after surgery, at the time of discharge and at weekly intervals until 12 weeks from surgery and at study completion using a validated questionnaire (QoR-40 Myles 2000 Appendix VI). In a recent systematic review of 'Recovery Specific Quality of Life Instruments' (Kluivers et al 2008) the QoR-40 was the best validated tool with regards to short term post operative recovery. A second questionnaire will be completed at the same times to assess symptoms of depression (Center for Epidemiologic Studies Depression Scale CES-D Appendix VII). With regards to urinary, bowel and sexual symptoms a 3rd validated questionnaire, the e-PAQ version 10 (Radley 2007 Appendix VIII) will be completed at recruitment, at the 6 week follow-up visit and at 6 months.