Bowel EndometriosisNCT02102529
Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis
An observational study of Bowel Endometriosis, run by Kepler University Hospital at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bowel Endometriosis
- What is being tested?
- laparoscopic colonic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- •Clinical diagnosis of endometriosis
Who cannot join
- Unwillingness to participate on the survey
Trial locations and contacts
1 site in 1 country.
Austria1 site
2nd Surgical Department, Academic Teaching Hospital, AKH Linz
Linz, Upper Austria, 4020
About this study
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
Read the detailed 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.
- Conditions
- Bowel Endometriosis
- Being tested
- laparoscopic colonic surgery
- Keywords
- pain, quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic colonic surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| bowel endometriosis | laparoscopic colonic resection Receives: Procedure: laparoscopic colonic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year after the operation
Secondary outcomes (5)
dyspareunia
comparison of dyspareunia before and one year after the operation
Measured: one year after the operation
dysuria
comparison of dysuria before and one year after the operation
Measured: one year after operation
obstipation
comparison of obstipation before and one year after the operation
Measured: one year after operation
pain during defecation
comparison of pain during defecation before and one year after the operation
Measured: one year after operation
rectal bleeding
comparison of rectal bleeding during menstruation before and one year after the operation
Measured: one year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy
- Investigators
- Andreas Shamiyeh, Univ-Prof.Dr, Study chair, Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102529
- Sponsor's protocol ID
- ENCO-014
- Other IDs
- ENCO-014
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2014
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21315335
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis
- ClinicalTrials.gov ID
- NCT02102529
- Acronym / sponsor ID
- ENCO-014
- Conditions
- Bowel Endometriosis
- Keywords
- pain, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bowel endometriosis | – | Procedure: laparoscopic colonic surgerylaparoscopic colonic resection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- •Clinical diagnosis of endometriosis
Key exclusion criteria (1 listed)
- Unwillingness to participate on the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic colonic surgerywomen with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012 | Procedure or surgery | bowel endometriosis |
Primary outcome
visual analog scala for pain
Time frame: one year after the operation
comparison of pain before and after the operation (one year later), value 0 til 10; 0= no pain, 10= strong pain
5 secondary outcomes
dyspareunia
Time frame: one year after the operation
dysuria
Time frame: one year after operation
obstipation
Time frame: one year after operation
pain during defecation
Time frame: one year after operation
rectal bleeding
Time frame: one year after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publication: PubMed 21315335Haas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Shamiyeh, Univ-Prof.Dr study chair
Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Endometriosis, run by Kepler University Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scala for pain (time frame: one year after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.