nerve-sparing laparaoscopic sacrocolpopexy
Procedurenerve-sparing laparaoscopic sacrocolpopexy implemented after 2010
Completed
NCT Number: NCT03667521
Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie
The aim was to evaluate the prevalence of stool outlet obstruction after laparoscopic sacrocolpopexie at the Kantonsspital Aarau in a prospective cross-sectional study.
Laparoscopic sacrocolpopexy techniques involving the dissection of the presacral space can compromise fibers of the superior hypogastric plexus. This can contribute to postoperative problems such as incomplete voiding, defecatory dysfunction, pain, and sensory problems. In 2010, the Kantonsspital Aarau has implemented a new nerve-sparing laparoscopic sacrocolpopexy technique. This technique has subjectively reduced the prevalence of stool outlet obstructions but this has not been tested systematically yet. The aim of this study is therefore to compare the patients' subjective conditions between these two surgical techniques using the investigator's standard-of-care German pelvic floor questionnaire.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
About this study
The (pre-) sacral space is characterized by a complex neuroanatomy and surgical intervention in this part of the body is often associated with the dissection of nerve bundels, a procedure which may finally lead to transient defecatory dysfunction. In a earlier study we could show that ~17.8% of patient with laparoscopic sacrocolpopexie developed postoperative constipation within 3-6 months. In november 2010 the Frauenklinik Aarau introduced a novel, nerve-sparing technique of laparoscopic sacrocolpopexie. In this study we assess the pre-and postoperative differences in defecatory dysfunction between the two procedures trough the analysis of our standard of care pelvic floor questionnaire.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Women affected by symptomatic vault prolapse, who underwent laparoscopic sacrocolpopexy at the KSA
- informed consent
Exclusion criteria
- participation in other studies
- Sacrocolpopexie done by Da Vinci Roboter
- Patients who had a conversion to laparotomy perioperatively
- Patients with a recurrence who had to undergo a second surgery
- Patients who had a relaps operation
Treatment and study plan
Primary outcomes
-
the number of de novo or worsened obstructed defecation
Time frame: 2003-2017
comparison of the number of de novo or worsened obstructed defecation of a cohort of patients who underwent nerve-sparing laparaoscopic sacrocolpopexy versus patients who underwent non-nerve-sparing laparaoscopic sacrocolpopexy
Sponsors and collaborators
Lead sponsor
Kantonsspital Aarau
Other
Registry information
Official study title
Prospective Cross-sectional Study on the Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie at the KSA
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Sep 12, 2018
- Registry last updated
- Sep 18, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.