Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP

NCT06245577 | Active Not Recruiting

• 1 other identifier: EVKKoeln_BioSynIRS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the pilot study is to demonstrate the safety and efficacy of a biological mesh compared to a standard synthetic mesh for the planned procedure in the above-mentioned clinical picture. Subsequently, a multicentre, randomized intervention study is planned to confirm the results and evaluate the long-term outcomes.

Conditions

Intestinal Obstruction; Pelvic Organ Prolapse; Rectal Prolapse

Keywords

rectopexy; sacro colpopexy

Outcome Measures

Primary Outcomes (1)

• safety of the experimental internvention as measured by surgical outcome

  Morbidity and mortality according to the Clavien-Dindo Classification (CDC) at 12 months after surgery (maximum value)

  12 months

Secondary Outcomes (4)

• Altomare Score for Obstruct4ed defecation syndrome (ODS)

  12 months

• Pelvic organ prolapse Quantification (POP Q)

  12 months

• Rectal Toxicity Score for bowel dysfunction

  12 months

• Wexner Incontinence Score for fecal incontinence

  12 months

Study Arms (2)

Biomesh

EXPERIMENTAL

Biodesign (TM) Rectopexy Graft Mesh used in the mesh sacropexy of the middle pelvic organ compartment (vagina, cervix, or uterus); the mesh fixes the middle pelvic organ compartment to the promontory

Device: interdisciplinary mesh sacro colpopexy with resection rectopexy

Synthetic mesh

ACTIVE COMPARATOR

DynaMesh (TM) VASA Mesh used in the mesh sacropexy of the middle pelvic organ compartment (vagina, cervix, or uterus); the mesh fixes the middle pelvic organ compartment to the promontory

Device: interdisciplinary mesh sacro colpopexy with resection rectopexy

Interventions

interdisciplinary mesh sacro colpopexy with resection rectopexy DEVICE

surgical reconstruction of the middel pelvic compartment with the above mentioned meshes combined with a resection rectopexy in a simultaneous interdisciplinary procedure

Biomesh; Synthetic mesh

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of obstructed defection syndrome
• clinical diagnosis of pelvic organ prolapse pelvic organ prolapse
• must be suitable for surgery

You may not qualify if:

• allergy to the components of the mesh
• pregnancy

Sponsors & Collaborators

• Evangelisches Klinikum Köln Weyertal gGmbH: lead
• University of Cologne: collaborator

Study Sites (1)

Evangelisches Klinikum Koeln Weyertal

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (7)

• Brunner M, Roth H, Gunther K, Grutzmann R, Matzel KE. Ventral rectopexy with biological mesh: short-term functional results. Int J Colorectal Dis. 2018 Apr;33(4):449-457. doi: 10.1007/s00384-018-2972-3. Epub 2018 Feb 13.

  PMID: 29442156 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Augusto KL, Bezerra LRPS, Murad-Regadas SM, Vasconcelos Neto JA, Vasconcelos CTM, Karbage SAL, Bilhar APM, Regadas FSP. Defecatory dysfunction and fecal incontinence in women with or without posterior vaginal wall prolapse as measured by pelvic organ prolapse quantification (POP-Q). Eur J Obstet Gynecol Reprod Biol. 2017 Jul;214:50-55. doi: 10.1016/j.ejogrb.2017.04.039. Epub 2017 Apr 26.

  PMID: 28477524 BACKGROUND

• Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J. 2020 Feb;31(2):291-301. doi: 10.1007/s00192-019-04035-3. Epub 2019 Jul 12.

  PMID: 31312846 BACKGROUND

• Ahmad M, Sileri P, Franceschilli L, Mercer-Jones M. The role of biologics in pelvic floor surgery. Colorectal Dis. 2012 Dec;14 Suppl 3:19-23. doi: 10.1111/codi.12045.

  PMID: 23136820 BACKGROUND

• de Mattos Lourenco TR, Pergialiotis V, Durnea C, Elfituri A, Haddad JM, Betschart C, Falconi G, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, and Standards in Urogynaecology and Women's Health. A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery. Int J Gynaecol Obstet. 2019 Apr;145(1):4-11. doi: 10.1002/ijgo.12766. Epub 2019 Feb 22.

  PMID: 30671950 BACKGROUND

• Clemons JL, Weinstein M, Guess MK, Alperin M, Moalli P, Gregory WT, Lukacz ES, Sung VW, Chen BH, Bradley CS; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):191-8. doi: 10.1097/SPV.0b013e31829099c1.

  PMID: 23797515 BACKGROUND

MeSH Terms

Conditions

Intestinal Obstruction; Pelvic Organ Prolapse; Rectal Prolapse

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Rectal Diseases

Study Officials

• Privatdozentin c Rudroff

  Evagelisches Klinikum Koeln Weyerta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: mesh material
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of the Deptartment of visceral surgery and functional surgery of the lower gastrointestinal tract

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 7, 2024
• Study Start: January 30, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: are available and may be requested until closure of the trial
• Access Criteria: request via email to the principal investigator

Locations

DE (1)