Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie

NCT ID: NCT03667521

Last Updated: 2018-09-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Stool Outlet Obstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type PROCEDURE

nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010

Interventions

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nerve-sparing laparaoscopic sacrocolpopexy

nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type BACKGROUND
PMID: 18536861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20542624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23538995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24700356 (View on PubMed)

Other Identifiers

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SACRO-GYN-KSA

Identifier Type: -

Identifier Source: org_study_id

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