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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02102529
Other study ID # ENCO-014
Secondary ID ENCO-014
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date December 2019

Study information

Verified date October 2023
Source Kepler University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Endometriosis is one of the most frequent benign diseases that can affect women in their reproductive age. In severe form, the colon or rectum may be involved. It has been shown that the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators evaluated the functional results and quality of life after laparoscopic colonic resection for endometriosis


Description:

A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012. Quality of life and pain was documented postoperatively. We conduct a telephone survey, which starts at May 2014.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2019
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - •Clinical diagnosis of endometriosis Exclusion Criteria: - Unwillingness to participate on the survey

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic colonic surgery
women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012

Locations

Country Name City State
Austria 2nd Surgical Department, Academic Teaching Hospital, AKH Linz Linz Upper Austria

Sponsors (1)

Lead Sponsor Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Haas D, Chvatal R, Habelsberger A, Wurm P, Schimetta W, Oppelt P. Comparison of revised American Fertility Society and ENZIAN staging: a critical evaluation of classifications of endometriosis on the basis of our patient population. Fertil Steril. 2011 Ap — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary visual analog scala for pain comparison of pain before and after the operation (one year later), value 0 til 10; 0= no pain, 10= strong pain one year after the operation
Secondary dyspareunia comparison of dyspareunia before and one year after the operation one year after the operation
Secondary dysuria comparison of dysuria before and one year after the operation one year after operation
Secondary obstipation comparison of obstipation before and one year after the operation one year after operation
Secondary pain during defecation comparison of pain during defecation before and one year after the operation one year after operation
Secondary rectal bleeding comparison of rectal bleeding during menstruation before and one year after the operation one year after operation
See also
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Recruiting NCT05291624 - Ultrasonographic and Surgical Assessment of Endometriosis by AAGL 2021 Endometriosis Classification