Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

Study Overview
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Brief Summary
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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
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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

Official Title
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Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

Conditions
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Prolapse Genital

Intervention / Treatment
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* Procedure: total abdominal hysterectomy
* Procedure: Subtotal abdominal hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh for all women with uterovaginal prolapse
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: total abdominal hysterectomy<br>Total abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse | Procedure: total abdominal hysterectomy<br>* total abdominal hysterectomy at time of sacrocolpopexy<br>|
| Active Comparator: subtotal abdominal hysterectomy<br>subtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse | Procedure: Subtotal abdominal hysterectomy<br>* Subtotal abdominal hysterectomy at time of sacrocolpopexy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh erosion | Mesh exposure through the lumen of the vagina, bladder, or rectum | 12 months or more | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | recurrence of vaginal wall prolapse or vault prolapse | 12 months or more | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, sacrocolpopexy