EndometriosisIRE-1NCT03565848
Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis
An observational study of Endometriosis and Bowel Endometriosis, run by Università degli Studi dell'Insubria.
Trial summary
Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Endometriosis, Bowel Endometriosis, Constipation
- What is being tested?
- Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with deep infiltrating endometriosis underwent laparoscopic surgery treatment with segmental intestinal resection.
Who may be able to join
- Patients referred for bowel endometriosis requiring colorectal resection
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis
Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.
- Conditions
- Endometriosis, Bowel Endometriosis, Constipation
- Being tested
- Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection
- Keywords
- Laparoscopy, Colorectal resection, Deep infiltrating endometriosis, Constipation
- Medical subject headings
- Endometriosis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resectionProcedure or surgery
Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.
| Study group | Role | What they receive |
|---|---|---|
| Women underwent colorectal resection for endometriosis | Women referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery. Receives: Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain
Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain
Measured: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain
Measured: Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain
Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.
Measured: Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery
Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain
Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.
Measured: Change from baseline dysuria at 60 days after surgery and at 1 year after surgery
Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain
Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.
Measured: Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery
Change in bowel symptoms evaluated by Constipation Assessment Scale
Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation).
Measured: Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery
Secondary outcomes (2)
Endometriosis characteristics
rAFS classification
Measured: intraoperative
Complication rate
Number of surgical complications (Clavien-Dindo Classification)
Measured: Within 6 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 posted21 Jun 2018
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Simone Garzon, M.D., Principal investigator, Universita di VeronaAntonio Simone Laganà, M.D., Principal investigator, UninsubriaPaola Pomini, M.D., Principal investigator, Universita di VeronaMassimo Franchi, M.D., Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565848
- Sponsor's protocol ID
- IRE-1
- Acronym
- IRE-1
- Status last verified
- Sep 2021
- First submitted
- 30 May 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT03565848
- Acronym / sponsor ID
- IRE-1 / IRE-1
- Conditions
- Endometriosis, Bowel Endometriosis, Constipation
- Keywords
- Laparoscopy, Colorectal resection, Deep infiltrating endometriosis, Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Jun 2018 (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.
Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women underwent colorectal resection for endometriosis | – | Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resectionWomen referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with deep infiltrating endometriosis underwent laparoscopic surgery treatment with segmental intestinal resection.
Key inclusion criteria (1 listed)
- Patients referred for bowel endometriosis requiring colorectal resection
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resectionLaparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. | Procedure or surgery | Women underwent colorectal resection for endometriosis |
Primary outcome
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain
Time frame: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery
Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
Time frame: Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery
Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain
Time frame: Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery
Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain
Time frame: Change from baseline dysuria at 60 days after surgery and at 1 year after surgery
Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain
Time frame: Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery
Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in bowel symptoms evaluated by Constipation Assessment Scale
Time frame: Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery
Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation).
2 secondary outcomes
Endometriosis characteristics
Time frame: intraoperative
Complication rate
Time frame: Within 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Simone Garzon, M.D. principal investigator
Universita di Verona
Antonio Simone Laganà, M.D. principal investigator
Uninsubria
Paola Pomini, M.D. principal investigator
Universita di Verona
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Bowel Endometriosis, run by Università degli Studi dell'Insubria.
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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Simone Laganà, M.D. (00393296279579, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain (time frame: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery). The study lists 6 primary outcomes in all. 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 2021.