EndometriosisNCT01953250
Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection
An observational study of Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- How many people
- 143 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to Jun 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis
Who may be able to join
- Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection
Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.
Read the detailed description
A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome).
Depending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.
- Conditions
- Endometriosis
- Keywords
- Deep infiltrating endometriosis, Laparoscopic sigmoid resection, laparoscopic rectum resection, Colorectal surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infiltrating endometriosis | 272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ColoRectal Functional Outcome
Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André JL D'Hoore, PhD, Principal investigator, University Clinics Gasthuisberg Department of Abdominal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953250
- Sponsor's protocol ID
- S-54351
- Status last verified
- Apr 2012
- First submitted
- 19 Feb 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection
- ClinicalTrials.gov ID
- NCT01953250
- Acronym / sponsor ID
- S-54351
- Conditions
- Endometriosis
- Keywords
- Deep infiltrating endometriosis, Laparoscopic sigmoid resection, laparoscopic rectum resection, Colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Sep 2013 (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.
Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.
Detailed description
A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome).
Depending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infiltrating endometriosis | – | –272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis
Key inclusion criteria (1 listed)
- Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ColoRectal Functional Outcome
Time frame: 1 day
Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012
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 30 Sep 2013.
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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.
André JL D'Hoore, PhD principal investigator
University Clinics Gasthuisberg Department of Abdominal Surgery
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 Endometriosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 30 Sep 2013. 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 Belgium. 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?
ColoRectal Functional Outcome (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2013.