Clinical trial NCT04178473: Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy
Official title: Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse Genital
Keywords: hysterectomy
sacrocolpopexy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Mesh erosion
timeFrame: 12 months or more
Secondary outcomes:
measure: recurrence
timeFrame: 12 months or more
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
state: Qena
Study officials:
affiliation: South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
name: Mohammad AM Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrington JW, Edwards G. Posthysterectomy vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):241-5. doi: 10.1007/s001920070033.
citation: Cayrac M, Warembourg S, Le Normand L, Fatton B. [Does hysterectomy modifies the anatomical and functional outcomes of prolapse surgery?: Clinical Practice Guidelines]. Prog Urol. 2016 Jul;26 Suppl 1:S73-88. doi: 10.1016/S1166-7087(16)30430-4. French.
citation: Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16.
citation: Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.
citation: Ismail S, Duckett J, Rizk D, Sorinola O, Kammerer-Doak D, Contreras-Ortiz O, Al-Mandeel H, Svabik K, Parekh M, Phillips C. Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion. Int Urogynecol J. 2016 Nov;27(11):1619-1632. doi: 10.1007/s00192-016-3076-7. Epub 2016 Jul 5.