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

NCT01825915 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-04-08

No results posted yet for this study

Summary

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).

Conditions

  • Benign Disease of the Uterus

Interventions

PROCEDURE

Laparoscopic Hysterectomy

PROCEDURE

Laparoscopic Supracervical Hysterectomy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825915 on ClinicalTrials.gov