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Early Safety of Resection Recopy and Sacrocolpopexy (RRPSCPcomb)

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ClinicalTrials.gov Identifier: NCT05910021
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH

Study Description
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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
Constipation by Outlet Obstruction Pelvic Organ Prolapse Urinary Incontinence

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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
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 : February 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 (


Outcome Measures
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Primary Outcome Measures :
  1. Safety of the procedure [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 months ]
    Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05910021


Contacts
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Contact: Claudia Rudroff, PD Dr. +492214795100 claudia@rudroff.com
Contact: Sebastian Ludwig, PD Dr. +494780 sebastian.ludwig@uk-koeln.de

Locations
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Germany
EVK Koeln Weyertal Recruiting
Cologne, NRW, Germany, 50931
Contact: Claudia Rudroff, PD Dr.    +492114795100    claudia@rudroff.com   
Contact: Claudia Rudroff, PD Dr.    +4915123534935    claudia.rudroff@evk-koeln.de   
Sponsors and Collaborators
Evangelisches Klinikum Köln Weyertal gGmbH
Investigators
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Principal Investigator: Claudia Rudroff EVK Köln Weyertal
More Information
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Responsible Party: Claudia Rudroff, Chief of the Department of General and visceral Surgery, Evangelisches Klinikum Köln Weyertal gGmbH
ClinicalTrials.gov Identifier: NCT05910021    
Other Study ID Numbers: EVK KOELN
RRP_SCP_interdisciplinary ( Other Identifier: EVK Köln )
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data available upon request to the study coordinator.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 01.01.2024-31.12.2027
Access Criteria: Access upon request to the study coordinator.
URL: https://evk-koeln.de
Additional relevant MeSH terms:
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Urinary Incontinence
Constipation
Prolapse
Pelvic Organ Prolapse
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, Digestive
Pathological Conditions, Anatomical