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Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

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Mass General Brigham

Status and phase

Withdrawn
Phase 3

Conditions

Gynecologic Diseases

Treatments

Procedure: Laparoscopic supracervical hysterectomy
Procedure: Total laparoscopic hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00734812
2007-P-002591/1

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

1
Active Comparator group
Description:
Laparoscopic supracervical hysterectomy (LSH)
Treatment:
Procedure: Laparoscopic supracervical hysterectomy
2
Active Comparator group
Description:
Total Laparoscopic Hysterectomy (TLH)
Treatment:
Procedure: Total laparoscopic hysterectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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