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OpenTrials
Completed

NCT Number: NCT04178473

Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

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

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Key information

Conditions

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

Qina, Qena Governorate, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse

Exclusion criteria

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

Treatment and study plan

Total abdominal hysterectomy

Procedure

total abdominal hysterectomy at time of sacrocolpopexy

Subtotal abdominal hysterectomy

Procedure

Subtotal abdominal hysterectomy at time of sacrocolpopexy

Primary outcomes

  1. Mesh erosion

    Time frame: 12 months or more

    Mesh exposure through the lumen of the vagina, bladder, or rectum

Secondary outcomes

  1. recurrence

    Time frame: 12 months or more

    recurrence of vaginal wall prolapse or vault prolapse

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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