Clinical trial NCT03667521: Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie
Official title: Prospective Cross-sectional Study on the Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie at the KSA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stool Outlet Obstruction
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients who underwent laparoscopic sacrocolpopexy at the Kantonsspital Aarau

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the number of de novo or worsened obstructed defecation
timeFrame: 2003-2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kantonsspital Aarau
name: Dimitri Sarlos, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.