Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie
NCT ID: NCT03667521
Last Updated: 2018-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2015-08-31
2018-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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non-nerve-sparing laparaoscopic sacrocolpopexy.
No interventions assigned to this group
nerve-sparing laparaoscopic sacrocolpopexy.
nerve-sparing laparaoscopic sacrocolpopexy
nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010
Interventions
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nerve-sparing laparaoscopic sacrocolpopexy
nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010
Eligibility Criteria
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Inclusion Criteria
* informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Kantonsspital Aarau
OTHER
Responsible Party
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Dimitri Sarlos
Head of the Womens Hospital Kantonsspital Aarau, chief of gynecology and gyn. oncology, head of the breast and gyn. tumor center
Principal Investigators
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Dimitri Sarlos, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Aarau
References
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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.
Other Identifiers
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SACRO-GYN-KSA
Identifier Type: -
Identifier Source: org_study_id
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