Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

September 20, 2021 updated by: Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: total abdominal hysterectomy
Total abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse
Procedure: total abdominal hysterectomy
total abdominal hysterectomy at time of sacrocolpopexy
ACTIVE_COMPARATOR: subtotal abdominal hysterectomy
subtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse
Procedure: Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy at time of sacrocolpopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesh erosion
Time Frame: 12 months or more
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
Time Frame: 12 months or more
recurrence of vaginal wall prolapse or vault prolapse
12 months or more

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 30, 2021

Study Completion (ACTUAL)

May 30, 2021

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGYN 0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared in unanonomous manner with the predetermined group of researchers

IPD Sharing Time Frame

throughout the period of research until end of the study

IPD Sharing Access Criteria

IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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