Early Safety of Resection Recopy and Sacrocolpopexy

NCT05910021 | Completed

• 2 other identifiers: EVK KOELNRRP_SCP_interdisciplinary
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. In cases surgery is required the interventions are characterized by individual approaches. Laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) was established in an interdisciplinary setting.

Conditions

Constipation by Outlet Obstruction; Pelvic Organ Prolapse; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Safety of the procedure

  Complication after Surgery by Clavien Dingo Score (minimum 0=no complication, 1= complication with no intervention, 2= complication with need for medication, 3a= complication with need for intervention, 3b = need for intervention under general anesthesia, 4a = septic complication, 4b= Multiorgan failure, and maximum 5= death

  12 months

Secondary Outcomes (2)

• pelvic organ prolapse (POP)

  12 months

• Defecation function

  12 months

Study Arms (1)

Women with ODS and POP

This pilot study established and standardized an interdisciplinary surgical approach of laparoscopic resection rectopexy (L-RRP) combined with a laparoscopic mesh sacrocolpopexy (L-SCP) used synonymously for sacrohysteropey and sacrocervicopexy, as well. Additionally, an absorbable biological mesh (

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years of age, not pregnant and suffering from the obstructed defecation disorder and a pelvic organ prolapse. Medical treatment was performed without success and surgery is needed.

You may qualify if:

• suffering from obstructed defecation and pelvic organ prolapse
• can undergo general anesthesia
• is eligible for laparoscopic surgery

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Evangelisches Klinikum Köln Weyertal gGmbH: lead

Study Sites (1)

EVK Koeln Weyertal

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (1)

• Rudroff C, Madukkakuzhy J, Hernandez AV, Otten J, Ulrici C, Karapanos L, Ludwig S. Early safety and efficiency outcomes of a novel interdisciplinary laparoscopic resection rectopexy combined with sacrocolpopexy for women with obstructive defecation syndrome and pelvic organ prolapse: a single center study. BMC Surg. 2024 Jun 14;24(1):185. doi: 10.1186/s12893-024-02474-4.

  PMID: 38877450 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Claudia Rudroff

  EVK Köln Weyertal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of General and visceral Surgery

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 18, 2023
• Study Start: February 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 01.01.2024-31.12.2027
• Access Criteria: Access upon request to the study coordinator.

Locations

DE (1)