Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function

St George's Healthcare NHS Trust

Status: Completed

Conditions: Hysterectomy

Treatments: Procedure: Total abdominal hysterectomy; Procedure: Subtotal abdominal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00750035

95.59.14

Details and patient eligibility

About

Background

It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.

Methods

The investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.

Enrollment: 279 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women having abdominal hysterectomy for benign conditions of the uterus

Exclusion criteria

• Suspected cancer
• A body weight that exceeded 100 kg
• Previous pelvic surgery
• Known endometriosis
• Abnormal cervical smears,
• Symptomatic uterine prolapse
• Symptomatic urinary incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

279 participants in 2 patient groups

1

Experimental group

Description:

total abdominal hysterectomy and

Treatment:

Procedure: Total abdominal hysterectomy

2

Experimental group

Description:

Subtotal hysterectomy

Treatment:

Procedure: Subtotal abdominal hysterectomy