Trial record 5 of 265 for:    hysterectomy

Feasibility of a Trial of Laparoscopic Hysterectomy Versus Laparoscopic Sub-Total Hysterectomy (LaHoST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
A.I. Hasib Ahmed, Medway NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01825915
First received: April 3, 2013
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention
Benign Disease of the Uterus
Procedure: Laparoscopic Hysterectomy
Procedure: Laparoscopic Supracervical Hysterectomy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medway NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Post-operative recovery [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Quality of recovery measured with validated questionnaires QoR 40 Myles 2006


Other Outcome Measures:
  • Depression score [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Depression score calculated with validated questionnaire CES-D Stanford 1996.


Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hysterectomy indicated for benign indications
  • Premenopausal

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825915

Locations
United Kingdom
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY
Sponsors and Collaborators
Medway NHS Foundation Trust
Johnson & Johnson
  More Information

Publications:

Responsible Party: A.I. Hasib Ahmed, Clinical Director of Women's Health, Medway NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01825915     History of Changes
Other Study ID Numbers: LaHoST protocol (v2)
Study First Received: April 3, 2013
Last Updated: April 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Medway NHS Foundation Trust:
Laparoscopic
Hysterectomy
Total
Subtotal
Recovery
Outcomes
Surgery

ClinicalTrials.gov processed this record on August 19, 2014