Early Safety of Resection Recopy and Sacrocolpopexy (RRPSCPcomb)

Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Constipation by Outlet Obstruction

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Claudia Rudroff, PD Dr.; Phone Number: +492214795100; Email: claudia@rudroff.com
• Study Contact Backup: Name: Sebastian Ludwig, PD Dr.; Phone Number: +494780; Email: sebastian.ludwig@uk-koeln.de

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50931
      • Recruiting
      • EVK Koeln Weyertal
      • Contact: Claudia Rudroff, PD Dr.; Phone Number: +492114795100; Email: claudia@rudroff.com
      • Contact: Claudia Rudroff, PD Dr.; Phone Number: +4915123534935; Email: claudia.rudroff@evk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 (

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pelvic organ prolapse (POP)	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)	12 months
Defecation function	Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)	12 months

Collaborators and Investigators

• Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
• Investigators: Principal Investigator: Claudia Rudroff, EVK Köln Weyertal

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms, Digestive; Urination Disorders; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Constipation
• Other Study ID Numbers: EVK KOELN; RRP_SCP_interdisciplinary (Other Identifier: EVK Köln)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data available upon request to the study coordinator.
• IPD Sharing Time Frame: 01.01.2024-31.12.2027
• IPD Sharing Access Criteria: Access upon request to the study coordinator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF