Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie
September 17, 2018 updated by: Dimitri Sarlos, Kantonsspital Aarau
Prospective Cross-sectional Study on the Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie at the KSA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
55
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
female patients who underwent laparoscopic sacrocolpopexy at the Kantonsspital Aarau
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non-nerve-sparing laparaoscopic sacrocolpopexy.
|
|
|
nerve-sparing laparaoscopic sacrocolpopexy.
|
nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2003-2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dimitri Sarlos, PD Dr. med., Kantonsspital Aarau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7.
- Shiozawa T, Huebner M, Hirt B, Wallwiener D, Reisenauer C. Nerve-preserving sacrocolpopexy: anatomical study and surgical approach. Eur J Obstet Gynecol Reprod Biol. 2010 Sep;152(1):103-7. doi: 10.1016/j.ejogrb.2010.05.009. Epub 2010 Jun 9.
- Cosma S, Menato G, Ceccaroni M, Marchino GL, Petruzzelli P, Volpi E, Benedetto C. Laparoscopic sacropexy and obstructed defecation syndrome: an anatomoclinical study. Int Urogynecol J. 2013 Oct;24(10):1623-30. doi: 10.1007/s00192-013-2077-z. Epub 2013 Mar 29.
- Sarlos D, Kots L, Ryu G, Schaer G. Long-term follow-up of laparoscopic sacrocolpopexy. Int Urogynecol J. 2014 Sep;25(9):1207-12. doi: 10.1007/s00192-014-2369-y. Epub 2014 Apr 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
September 10, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 12, 2018
Study Record Updates
Last Update Posted (Actual)
September 18, 2018
Last Update Submitted That Met QC Criteria
September 17, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SACRO-GYN-KSA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.