Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

LSH vs. TLH, A Randomized Single Blind Trial

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734812

Enrollment

Registered

2008-08-14

Start date

2008-05-31

Completion date

2012-01-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Diseases

Keywords

Hysterectomy, Laparoscopic

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.

Interventions

PROCEDURELaparoscopic supracervical hysterectomy

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

PROCEDURETotal laparoscopic hysterectomy

Patients will be randomized to either removal or retention of cervix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Return to normal activities	3-6 weeks after surgery

Secondary

Measure	Time frame
Sexual function	6 months after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026