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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

Tracking Information
First Submitted Date June 10, 2023
First Posted Date June 18, 2023
Last Update Posted Date June 23, 2023
Actual Study Start Date February 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2023)		 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
Original Primary Outcome Measures
 (submitted: June 10, 2023)		 Clavin Dindo Classification [ Time Frame: 12 months ]
Morbidity
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2023)
  • 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)
  • Defecation function [ Time Frame: 12 months ]
    Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)
Original Secondary Outcome Measures
 (submitted: June 10, 2023)
  • defecation function [ Time Frame: 12 months ]
    Altomare score
  • pelvic organ prolapse [ Time Frame: 12 months ]
    POP ,measured by POP-Q
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Safety of Resection Recopy and Sacrocolpopexy
Official Title Early Safety and Efficiency of Interdisciplinary Laparoscopic Resection Rectopexy Combined With Sacrocolpopexy for Women With Obstructive Defecation Syndrome and Pelvic Organ Prolapse
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.
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
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Constipation by Outlet Obstruction
  • Pelvic Organ Prolapse
  • Urinary Incontinence
Intervention Not Provided
Study Groups/Cohorts 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 (
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 10, 2023)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Claudia Rudroff, PD Dr. +492214795100 claudia@rudroff.com
Contact: Sebastian Ludwig, PD Dr. +494780 sebastian.ludwig@uk-koeln.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT05910021
Other Study ID Numbers EVK KOELN
RRP_SCP_interdisciplinary ( Other Identifier: EVK Köln )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data available upon request to the study coordinator.
Supporting Materials: Study Protocol
Supporting Materials: 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
Current Responsible Party Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH
Original Responsible Party Same as current
Current Study Sponsor Evangelisches Klinikum Köln Weyertal gGmbH
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Claudia Rudroff EVK Köln Weyertal
PRS Account Evangelisches Klinikum Köln Weyertal gGmbH
Verification Date June 2023