Early Safety of Resection Recopy and Sacrocolpopexy

Completed

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

• Registration Number: NCT05910021
• Lead Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH

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 Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-10
• Study First Posted: 2023-06-18
• Primary Completion: 2024-03-31
• Study Completion: 2024-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Defecation function	12 months	Altomare score (6 items, minimum=0, maximum = 32 points; the more points, the worse the defecation function)

Trial Locations

Locations (1)

EVK Koeln Weyertal; 🇩🇪 Cologne, NRW, Germany