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

NCT01825915 | Unknown

• 1 other identifier: LaHoST protocol (v2)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic; Hysterectomy; Total; Subtotal; Recovery; Outcomes; Surgery

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  Rate of recruitment. Rate of refusal. Completion of data at enrolment, at 12 weeks, at 6 months, at 12 months.

  30 Months

Secondary Outcomes (1)

• Post-operative recovery

  30 months

Other Outcomes (1)

• Depression score

  30 months

Study Arms (2)

Laparoscopic Hysterectomy

ACTIVE COMPARATOR

Laparoscopic hysterectomy involving removal of both uterine corpus and cervix

Procedure: Laparoscopic Hysterectomy

Laparoscopic Supracervical Hysterectomy

ACTIVE COMPARATOR

Laparoscopic hysterectomy involving removal of the uterine corpus alone with conservation of the cervix.

Procedure: Laparoscopic Supracervical Hysterectomy

Interventions

Laparoscopic Hysterectomy PROCEDURE

Laparoscopic Hysterectomy

Laparoscopic Supracervical Hysterectomy PROCEDURE

Laparoscopic Supracervical Hysterectomy

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hysterectomy indicated for benign indications
• Premenopausal

You may not qualify if:

• Post menopausal women
• Suspected malignancy
• Abnormal cervical smears or a history of treatment of a high grade cervical intraepithelial neoplasia within 3 years of recruitment.
• Raised BMI (Body Mass Index) \> 35Kg/M2
• Uterovaginal prolapse \> Stage 1 (Bump et al 1996).
• Previous gynaecological malignancy
• Previous extensive pelvic surgery
• Psychological/psychiatric disease
• Anti-depressant/anti-psychotic therapy
• Unable to read and write English

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Related Publications (14)

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  PMID: 12397189 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of Women's Health

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 8, 2013
• Study Start: September 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

GB (1)