Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

NCT04178473 | Completed DMC

• 1 other identifier: OBGYN 0101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Prolapse Genital

Keywords

hysterectomy; sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• Mesh erosion

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

  12 months or more

Secondary Outcomes (1)

• recurrence

  12 months or more

Study Arms (2)

total abdominal hysterectomy

ACTIVE COMPARATOR

Total abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse

Procedure: total abdominal hysterectomy

subtotal abdominal hysterectomy

ACTIVE COMPARATOR

subtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse

Procedure: Subtotal abdominal hysterectomy

Interventions

total abdominal hysterectomy PROCEDURE

total abdominal hysterectomy at time of sacrocolpopexy

total abdominal hysterectomy

Subtotal abdominal hysterectomy PROCEDURE

Subtotal abdominal hysterectomy at time of sacrocolpopexy

subtotal abdominal hysterectomy

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

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

Qina, Qena Governorate, Egypt

Location

Related Publications (5)

• Barrington JW, Edwards G. Posthysterectomy vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):241-5. doi: 10.1007/s001920070033.

  PMID: 11005477 BACKGROUND

• 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.

  PMID: 27595628 BACKGROUND

• 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.

  PMID: 29038834 BACKGROUND

• 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.

  PMID: 18976976 BACKGROUND

• 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.

  PMID: 27379891 BACKGROUND

Study Officials

• Mohammad AM Ahmed, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) closed envelop will be used for randomization. The patient and the investigator will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: January 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: May 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: throughout the period of research until end of the study
• Access Criteria: IPD will be shared with the predetermined group of researchers as accepted by the local ethical and research committee.

Locations

EG (1)