Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

Gynecologic Diseases Clinical Trial

Official title:

LSH vs. TLH, A Randomized Single Blind Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00734812
• Other study ID #: 2007-P-002591/1
• Status: Withdrawn
• Phase: Phase 3
• First received: August 12, 2008
• Last updated: January 23, 2013
• Start date: May 2008
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.

Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).

Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.

6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidates for laparoscopic hysterectomy for benign indications

Exclusion Criteria:

• Malignancy of the uterus, cervix or adnexa

• pre-malignant changes of the uterus, cervix or adnexa

• history of severe cervical dysplasia (CIN II or above)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Diseases

Intervention

Procedure:
• Laparoscopic supracervical hysterectomy
Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
• Total laparoscopic hysterectomy
Patients will be randomized to either removal or retention of cervix

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to normal activities		3-6 weeks after surgery	No
Secondary	Sexual function		6 months after surgery	No