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Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04178473
Enrollment
70
Registered
2019-11-26
Start date
2019-01-01
Completion date
2021-05-30
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolapse Genital

Keywords

hysterectomy, sacrocolpopexy

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

Interventions

total abdominal hysterectomy at time of sacrocolpopexy

Subtotal abdominal hysterectomy at time of sacrocolpopexy

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double (Participant, Investigator) closed envelop will be used for randomization. The patient and the investigator will be blinded.

Intervention 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

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mesh erosion12 months or moreMesh exposure through the lumen of the vagina, bladder, or rectum

Secondary

MeasureTime frameDescription
recurrence12 months or morerecurrence of vaginal wall prolapse or vault prolapse

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026