Deep EndometriosisNCT06761157
Transrectal Evaluation After Discoid Resection for Endometriosis Intestinal
An observational study of Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Deep Endometriosis
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2022to 29 Mar 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients diagnosed with deep endometriosis with suspected bowel involvement who will undergo segmental or discoid resection for the period of one year following the date of study approval
Who may be able to join
- Women between the ages of 18 and 50 years
- Women with diagnosis made by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected bowel involvement
- Women undergoing segmental or discoid resection for bowel endometriosis
- Obtaining informed consent
Who cannot join
- Patients who are candidates for elective laparotomic surgery
- Patients with concomitant inflammatory bowel disease known in history (inflammatory bowel syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transrectal Evaluation After Discoid Resection For Endometriosis Intestinal
Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery
Read the detailed description
Endometriosis is an inflammatory, benign, oestrogen-dependent condition that affects 10-15% of women of reproductive age. It is characterised by the presence of endometrial tissue, glands and stroma, outside the uterine cavity. Endometriosis may present in the pelvis as superficial peritoneal, ovarian or deep infiltrating. The reported prevalence of bowel or recto-vaginal space involvement among women with endometriosis ranges from 5% to 25% (2). Surgery is the treatment of choice for deep endometriosis with bowel involvement when drug therapy alone is ineffective in treating symptoms. Surgical techniques for intestinal endometriosis can be divided into full-thickness techniques (discoid or segmental resection) and non-full-thickness techniques (shaving).
Focusing on women who underwent a discoid resection, 3.7% of 80 reported a recto-vaginal fistula and the same percentage showed early rectorrhagia requiring endoscopic treatment after surgery. In general surgery rectosigmoidoscopy has shown encouraging results as a feasible, safe and effective technique in reducing the risk of complications related to intestinal anastomosis. There are no studies in the literature evaluating the role of rectosigmoidoscopy as a routine practice in gynaecological surgery for endometriosis, so we rely on the experience of general surgeons. In particular, the lack of data does not allow us to evaluate the feasibility of rectosigmoidoscopy during deep endometriosis surgery in terms of the success of the procedure itself and the additional operative time taken. The latter aspect is also important from the point of view of health policy due to the increased cost of the operating theatre directly related to the time taken for the procedure.
- Conditions
- Deep Endometriosis
- Keywords
- endometriosis, discoid resection, deep endometriosis, intestinal
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery
Ratio of the number of successfully completed interventions to the total number of interventions performed using rectosigmoidoscopy. The success of the intervention is determined following qualitative evaluation of the anastomosis
Measured: 3 months after surgery
Secondary outcomes (3)
Incidence of intraoperative complications: rectorrhagia, leakage, mucosal crash, intussusception, anastomosis stenosis, intraperitoneal hemorrhage, conversion to laparotomy surgery
Ratio of the number of procedures in which any of the intraoperative complications described above occurred to the total number of procedures using rectosigmoidoscopy
Measured: During surgery
Incidence of postoperative complications within the first three months post-segmental or discoid resection surgery among patients undergoing rectosigmoidoscopy and patients undergoing the same surgery without rectosigmoidoscopy
Ratio of the number of surgeries in which any of the above postoperative complications occurred to the total number of surgeries using rectosigmoidoscopy
Measured: 3 months after surgery
Operating time duration in patients undergoing discoid or segmental resection with or without the use of intraoperative rectosigmoidoscopy
Percentage difference between average surgical durations in patients undergoing resection surgery with and without a rectosigmoidoscopy procedure. Lacking baseline data, an increase, compared with patients who did not undergo rectosigmoidoscopy, of up to 20% in average surgical time is considered reasonable
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start21 Mar 2022
- Primary completion31 Dec 2023
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Casadio, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761157
- Sponsor's protocol ID
- RESDISCO2021
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Evaluation After Discoid Resection For Endometriosis Intestinal
- ClinicalTrials.gov ID
- NCT06761157
- Acronym / sponsor ID
- RESDISCO2021
- Conditions
- Deep Endometriosis
- Keywords
- endometriosis, discoid resection, deep endometriosis, intestinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 7 Jan 2025 (actual)
- 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.
Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery
Detailed description
Endometriosis is an inflammatory, benign, oestrogen-dependent condition that affects 10-15% of women of reproductive age. It is characterised by the presence of endometrial tissue, glands and stroma, outside the uterine cavity. Endometriosis may present in the pelvis as superficial peritoneal, ovarian or deep infiltrating. The reported prevalence of bowel or recto-vaginal space involvement among women with endometriosis ranges from 5% to 25% (2). Surgery is the treatment of choice for deep endometriosis with bowel involvement when drug therapy alone is ineffective in treating symptoms. Surgical techniques for intestinal endometriosis can be divided into full-thickness techniques (discoid or segmental resection) and non-full-thickness techniques (shaving).
Focusing on women who underwent a discoid resection, 3.7% of 80 reported a recto-vaginal fistula and the same percentage showed early rectorrhagia requiring endoscopic treatment after surgery. In general surgery rectosigmoidoscopy has shown encouraging results as a feasible, safe and effective technique in reducing the risk of complications related to intestinal anastomosis. There are no studies in the literature evaluating the role of rectosigmoidoscopy as a routine practice in gynaecological surgery for endometriosis, so we rely on the experience of general surgeons. In particular, the lack of data does not allow us to evaluate the feasibility of rectosigmoidoscopy during deep endometriosis surgery in terms of the success of the procedure itself and the additional operative time taken. The latter aspect is also important from the point of view of health policy due to the increased cost of the operating theatre directly related to the time taken for the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with deep endometriosis with suspected bowel involvement who will undergo segmental or discoid resection for the period of one year following the date of study approval
Key inclusion criteria (4 listed)
- Women between the ages of 18 and 50 years
- Women with diagnosis made by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected bowel involvement
- Women undergoing segmental or discoid resection for bowel endometriosis
- Obtaining informed consent
Key exclusion criteria (2 listed)
- Patients who are candidates for elective laparotomic surgery
- Patients with concomitant inflammatory bowel disease known in history (inflammatory bowel syndrome)
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
Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery
Time frame: 3 months after surgery
Ratio of the number of successfully completed interventions to the total number of interventions performed using rectosigmoidoscopy. The success of the intervention is determined following qualitative evaluation of the anastomosis
3 secondary outcomes
Incidence of intraoperative complications: rectorrhagia, leakage, mucosal crash, intussusception, anastomosis stenosis, intraperitoneal hemorrhage, conversion to laparotomy surgery
Time frame: During surgery
Incidence of postoperative complications within the first three months post-segmental or discoid resection surgery among patients undergoing rectosigmoidoscopy and patients undergoing the same surgery without rectosigmoidoscopy
Time frame: 3 months after surgery
Operating time duration in patients undergoing discoid or segmental resection with or without the use of intraoperative rectosigmoidoscopy
Time frame: 3 months after surgery
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 7 Jan 2025.
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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.
Paolo Casadio, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Italy. 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?
Success rate of rectosigmoidoscopic procedure in patients with deep endometriosis with bowel involvement undergoing segmental or discoid resection surgery (time frame: 3 months after surgery). 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 7 Jan 2025.