RRPSCPcomb: Early Safety of Resection Recopy and Sacrocolpopexy

Evangelisches Klinikum Köln Weyertal gGmbH (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception). The patients must exert pressure to evacuate the rectum and manual manipulation may be required. The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10%-25% of the population and is mainly related to female sex. The condition is frequently associated with POP. On the other hand almost 60% of the female population develop POP during their lifetime and 1/3 of them suffer bowel dysfunction. Individual aspects, such as pregnancy, childbirth, connective tissue disorders, and surgical interventions further contribute to the condition. The women experience frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options are limited and do not achieve the desired long-term effect.

    The surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor and has been characterized by individual approaches.

    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 all surgical reconstructions. Additionally, an absorbable biological mesh (BM) for L-SCP was offered for women who wished to preserve the uterus in cases of a planned pregnancy and those, who asked for an alternative to the synthetic mesh (SM).

    • Endpoints of the study The primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure.as measured by postoperative morbidity and mortality and measured. The secondary outcome parameters were clinical and anatomical outcomes as measured by scores.

    • Data management and statistical analysis The necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed. Quantitative variables are described as means (± standard deviation) and were compared using the Kruskal-Wallis H test and Mann-Whitney U test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher's exact test. A two-sided p value of <0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analysis were exploratory.

    Study Design

    Study Type:
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse
    Actual Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Nov 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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 (

    Outcome Measures

    Primary Outcome Measures

    1. Safety of the procedure [12 months]

      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

    Secondary Outcome Measures

    1. pelvic organ prolapse (POP) [12 months]

      POP measured by POP-Q (Score ranges from 0= no POP, 1= POP until 2 cm before the hymnal line, 2= POP reached the hymnal line, 3= POP exceeds the hymnal line, 4= full extravgtnal prolapse)

    2. Defecation function [12 months]

      Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • suffering from obstructed defecation and pelvic organ prolapse

    • can undergo general anesthesia

    • is eligible for laparoscopic surgery

    Exclusion Criteria:
    • pregnancy

    Contacts and Locations


    Site City State Country Postal Code
    1 EVK Koeln Weyertal Cologne NRW Germany 50931

    Sponsors and Collaborators

    • Evangelisches Klinikum Köln Weyertal gGmbH


    • Principal Investigator: Claudia Rudroff, EVK Köln Weyertal

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Claudia Rudroff, Chief of the Department of General and visceral Surgery, Evangelisches Klinikum Köln Weyertal gGmbH
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • RRP_SCP_interdisciplinary
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2023