EndometriosisPhase 3NCT00939861
Laparoscopy Versus Laparotomy for Colorectal Endometriosis
A Phase 3 study testing laparoscopy and laparotomy in people with Endometriosis, run by Tenon Hospital, Paris at 1 site in France.
Trial summary
Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- laparoscopy and laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Sep 2009
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients over 18 years old
- patients with colorectal endometriosis
- patients affiliated to the French Health Care system
- patients having signed the inform consent.
- patients who can speak and read French
Who cannot join
- patients with prior colorectal surgery
- patients with a contraindication to laparoscopy
Trial locations and contacts
1 site in 1 country.
France1 site
Tenon Hospital, Departement of Obstetrics and Gynecology
Paris, Paris, 75020
About this study
Official title: Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.
Read the detailed description
For all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.Among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. Quality of life will be assessed using the SF-36 questionnaire. The allocation of the surgical route will be conducted by lottery the day before surgery. Patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. The duration of the study will be 7 months for the patient and 24 months in total.If considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.
- Conditions
- Endometriosis
- Being tested
- laparoscopy, laparotomy
- Keywords
- colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyProcedure or surgery
colorectal resection
laparotomyProcedure or surgery
colorectal resection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | laparoscopy Receives: Procedure: laparoscopy |
| 2 | Experimental | laparotomy Receives: Procedure: laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dyschesia at 6 months using a visual analogue scale
Measured: at 6 months
Secondary outcomes (4)
Evaluation of gynaecologic symptoms (dysmenorrhea, dyspareunia), digestive symptoms (diarrhea, constipation , intestinal cramps) and general symptoms (asthenia, back pain) at 6 months using visual analogue scale
Measured: at 6 months
Evaluation of quality of life at 6 months using SF-36 questionnaire
Measured: at 6 months
Morbidity
Measured: During 6 months
Postoperative fertility
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionSep 2009 (estimated)
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenon Hospital, Paris
- Sponsor type
- University, hospital or other
- Investigators
- emile Daraï, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939861
- Sponsor's protocol ID
- 13072009
- Status last verified
- Jul 2009
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.
PubMed 25294552
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
- ClinicalTrials.gov ID
- NCT00939861
- Acronym / sponsor ID
- 13072009
- Conditions
- Endometriosis
- Keywords
- colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tenon Hospital, ParisUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 15 Jul 2009 (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.
Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.
Detailed description
For all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.Among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. Quality of life will be assessed using the SF-36 questionnaire. The allocation of the surgical route will be conducted by lottery the day before surgery. Patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. The duration of the study will be 7 months for the patient and 24 months in total.If considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: laparoscopylaparoscopy |
| 2 | Experimental | Procedure: laparotomylaparotomy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients over 18 years old
- patients with colorectal endometriosis
- patients affiliated to the French Health Care system
- patients having signed the inform consent.
- patients who can speak and read French
Key exclusion criteria (2 listed)
- patients with prior colorectal surgery
- patients with a contraindication to laparoscopy
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 |
|---|---|---|
| laparoscopycolorectal resection | Procedure or surgery | 1 |
| laparotomycolorectal resection | Procedure or surgery | 2 |
Primary outcome
Evaluation of dyschesia at 6 months using a visual analogue scale
Time frame: at 6 months
4 secondary outcomes
Evaluation of gynaecologic symptoms (dysmenorrhea, dyspareunia), digestive symptoms (diarrhea, constipation , intestinal cramps) and general symptoms (asthenia, back pain) at 6 months using visual analogue scale
Time frame: at 6 months
Evaluation of quality of life at 6 months using SF-36 questionnaire
Time frame: at 6 months
Morbidity
Time frame: During 6 months
Postoperative fertility
Time frame: during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 25294552Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.
Related trials for Endometriosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
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.
emile Daraï, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laparoscopy and laparotomy in people with Endometriosis, run by Tenon Hospital, Paris at 1 site in France.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jul 2009. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Evaluation of dyschesia at 6 months using a visual analogue scale (time frame: at 6 months). 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 NCT00939861, 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 15 Jul 2009.