NCT02102529

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

March 30, 2014

Last Update Submit

October 5, 2023

Conditions

Keywords

painquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • dyspareunia

    one year after the operation

  • dysuria

    one year after operation

  • obstipation

    one year after operation

  • pain during defecation

    one year after operation

  • rectal bleeding

    one year after operation

Study Arms (1)

bowel endometriosis

laparoscopic colonic resection

Procedure: laparoscopic colonic surgery

Interventions

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

bowel endometriosis

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of endometriosis

You may not qualify if:

  • Unwillingness to participate on the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Linz, Upper Austria, 4020, Austria

Location

Related 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 Apr;95(5):1574-8. doi: 10.1016/j.fertnstert.2011.01.135.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Shamiyeh, Univ-Prof.Dr

    Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 3, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2019

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations