Feasibilty of a Double Blind Randomised Controlled Trial to Compare Post-operative Recovery following Laparoscopic Hysterectomy with Post-operative Recovery following Laparoscopic Sub-total Hysterectomy - The LaHoST Study
Abu Imad Hasib Ahmed, Hany Wisa, Jeremy Wright
Observational studies suggest faster recovery and quicker return to normal activities following
laparoscopic supracervical hysterectomy (LSH) compared with laparoscopic hysterectomy (LH) in
women with benign uterine disease. Data from the only randomised controlled trial (RCT) on the topic
does not support this observation.
We have investigated the feasibility of a double blind RCT comparing post-operative recovery following
LH with that following LSH. 70 women were invited to participate from a single gynaecological
surgeon’s caseload 20 women were excluded. Web based randomisation was carried out at the time of
study laparoscopy. Surgery was performed using a standardised technique.
Participants and the data handler were blinded to treatment allocation.
Primary outcome was feasibility of recruitment. Secondary outcomes included validated post-operative
recovery and mood questionnaires at baseline, prior to discharge and at weekly intervals for 12 weeks.
Validated questionnaires regarding pelvic floor function and sexual function were assessed at baseline,
6 weeks and 6 months. Recruitment and treatment of 50 women was completed within 18 months. Less
than 30% of eligible invitees were excluded and the commonest reason for exclusion was a strong
opinion regarding conservation or removal of the cervix (8/70 = 11.4%). 96% of participants received
treatment according to randomisation. Data collection was complete at 6 weeks for 88%. Recovery
scores were similar to pre-op at 3 weeks for LSH and at 4 weeks for LH. Subjects had returned to normal
activity ‘all of the time’ by 6 weeks for LSH and by 8 weeks for LH.
In conclusion the definitive study appears feasible. The observed advantage in short term recovery
following LSH compared to LH appears to be supported. If a difference in QoR score of 5 is clinically
significant and power is set at 0.8 with α at 0.05 the definitive study will require 186 women in either
arm.
