Feasibility of a Trial of Laparoscopic Hysterectomy Versus Laparoscopic Sub-Total Hysterectomy (LaHoST)
Observational studies suggest faster recovery and quicker return to normal activities following laparoscopic supracervical hysterectomy (LSH which involves removal of the body of the womb but conservation of the neck of the womb or cervix) compared with laparoscopic hysterectomy (LH in which both the body and neck of the womb are removed) in women with benign uterine disease. Data from the only randomised controlled trial (RCT) on the topic does not support this observation.
The investigators set out to investigate the feasibility of a double blind RCT comparing post-operative recovery following LH with that following LSH.
The investigators set out to recruit 50 participants from a single gynaecological surgeon's caseload. 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 (double blind study where neither the patient nor the surgeon have knowledge of treatment group allocation at the time of questionnaire analysis).
Primary outcome is feasibility of recruitment to the study. The null hypothesis for this study is that 'a double blind, randomised controlled comparison of recovery following laparoscopic hysterectomy with recovery following laparoscopic sub-total hysterectomy' is not feasible.
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 will be assessed at baseline, 6 weeks and 6 months.
The findings of the feasibility study will inform the power calculation for a planned definitive study ( the magnitude of the differences found between the 2 arms of the feasibility study will allow calculation of the total number of participants required in a definitive study to allow demonstration of statistically significant differences in outcomes).
Benign Disease of the Uterus
Procedure: Laparoscopic Hysterectomy
Procedure: Laparoscopic Supracervical Hysterectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility of a Randomised Controlled Trial of Laparoscopic Hysterectomy Versus Laparoscopic Sub-Total Hysterectomy|
- Study Feasibility [ Time Frame: 30 Months ] [ Designated as safety issue: No ]Rate of recruitment. Rate of refusal. Completion of data at enrolment, at 12 weeks, at 6 months, at 12 months.
- Post-operative recovery [ Time Frame: 30 months ] [ Designated as safety issue: No ]Quality of recovery measured with validated questionnaires QoR 40 Myles 2006
- Depression score [ Time Frame: 30 months ] [ Designated as safety issue: No ]Depression score calculated with validated questionnaire CES-D Stanford 1996.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Laparoscopic Hysterectomy
Laparoscopic hysterectomy involving removal of both uterine corpus and cervix
|Procedure: Laparoscopic Hysterectomy|
Active Comparator: Laparoscopic Supracervical Hysterectomy
Laparoscopic hysterectomy involving removal of the uterine corpus alone with conservation of the cervix.
|Procedure: Laparoscopic Supracervical Hysterectomy|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825915
|Medway NHS Foundation Trust|
|Gillingham, Kent, United Kingdom, ME7 5NY|