Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

NCT00734812 | Withdrawn Phase 3

• 1 other identifier: 2007-P-002591/1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Diseases

Keywords

Hysterectomy; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Return to normal activities

  3-6 weeks after surgery

Secondary Outcomes (1)

• Sexual function

  6 months after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Laparoscopic supracervical hysterectomy (LSH)

Procedure: Laparoscopic supracervical hysterectomy

2

ACTIVE COMPARATOR

Total Laparoscopic Hysterectomy (TLH)

Procedure: Total laparoscopic hysterectomy

Interventions

Laparoscopic supracervical hysterectomy PROCEDURE

Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)

1

Total laparoscopic hysterectomy PROCEDURE

Patients will be randomized to either removal or retention of cervix

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for laparoscopic hysterectomy for benign indications

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jon I. Einarsson, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Minimally Invasive Gynecology

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)