Clinical trial NCT05910021: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation by Outlet Obstruction
Pelvic Organ Prolapse
Urinary Incontinence
Lead sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Safety of the procedure
timeFrame: 12 months
Secondary outcomes:
measure: pelvic organ prolapse (POP)
timeFrame: 12 months
measure: Defecation function
timeFrame: 12 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: EVK Koeln Weyertal
state: NRW
Study officials:
affiliation: EVK Köln Weyertal
name: Claudia Rudroff
role: PRINCIPAL_INVESTIGATOR
References: