Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

Not Applicable

Completed

• Conditions: Prolapse Genital
• Interventions: Procedure: total abdominal hysterectomy; Procedure: Subtotal abdominal hysterectomy

• Registration Number: NCT04178473
• Lead Sponsor: South Valley University

Brief Summary

Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women.

In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.

Study design: Randomized controlled trial

Intervention:

Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy

Detailed Description

Uterovaginal prolapse is a common disease. Sacrocolpopexy is essentially invented to manage prolapse of the vault following hysterectomy. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. The main drawback of sacrocolpopexy is the risk of mesh erosion. The incidence of mesh erosion is 0-5% at follow up of 1 year and 0.5% at follow up of 7 years. After total hysterectomy, the mesh is sutured to the vaginal wall using non-absorbable sutures. Sutures that span the whole thickness of vaginal and involve the vaginal skin was considered the probable factor that result in mesh erosion. After subtotal hysterectomy, the mesh is fixed to the anterior and the posterior cervical surfaces. The cervix has thick wall and the risk associated with "deep" stiches does not exist.

In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.

Patients and methods

Study design:

Randomized controlled trial

Patients:

Data will be collected from the patients admitted to the obstetrics and gynecology department, Qen faculty of medicine, South Valley University, Egypt from the 1st of January 2019 until 30th of December 2019. Follow up data will be collected until 30th of December 2020. Written consent will be obtained at time of recruitment. The Inclusion criteria are nonhystrectomized patients who will undergo sacrocolpopexy. Exclusion criteria were (1) women age less than 40; (2) desire to retain the uterus; (3) women who are unfit for lengthy surgery. Randomization will be through closed envelop method.

Intervention Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh. Both groups will be done by the same surgeon using the following technique: dissection of the vesicovaginal and the rectovaginal spaces to prepare for the site of mesh placement. Dissection will be continued in the rectovaginal septum using sharp and blunt dissection until reaching the level of the levator ani (the length of the posterior vaginal mesh arm is nearly equal to the total vaginal length). The limit of the dissection in the vesicovaginal plane is down to the bladder neck (known by palpation of the Foley's catheter balloon) after lateralization of the ureters. The mesh is sutured to the anterior and the posterior vaginal wall the mesh using non-absorbable sutures. In women with subtotal hysterectomy, the mesh will be also sutured to the cervix. The mesh is then sutured to the anterior longitudinal ligament on the anterior surface of the fifth lumbar vertebra and the sacral promontory using non-absorbable sutures. Suturing of the peritoneum over the mesh will be done.

Outcomes:

The primary outcome will be mesh erosion. Secondary outcomes will be complications including recurrence

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Primary Completion: 2021-01-30
• Study Completion: 2021-05-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse

Read More

Exclusion Criteria

• women age less than 40
• desire to retain the uterus
• women who are unfit for lengthy surgery

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total abdominal hysterectomy	total abdominal hysterectomy	Total abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse
subtotal abdominal hysterectomy	Subtotal abdominal hysterectomy	subtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse

Primary Outcome Measures

Name	Time	Method
Mesh erosion	12 months or more	Mesh exposure through the lumen of the vagina, bladder, or rectum

Secondary Outcome Measures

Name	Time	Method
recurrence	12 months or more	recurrence of vaginal wall prolapse or vault prolapse

Trial Locations

Locations (1)

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department; 🇪🇬 Qinā, Qena, Egypt