Surgical TReatment of Women With Deep ENDometriosis
TrEnd
1 other identifier
observational
250
1 country
1
Brief Summary
TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2023
CompletedFirst Submitted
Initial submission to the registry
April 23, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
April 26, 2024
April 1, 2024
4.7 years
April 23, 2024
April 23, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection
Percentage
10 years
To assess the rate of complications
Rate/percentage
10 years
To assess the rate of conversion to open surgery
Rate/percentage
10 years
To assess the rate of endometriosis-free bowel resection margins
Rate/percentage
10 years
To assess the rate of recurrence
Rate/percentage
10 years
Secondary Outcomes (5)
To assess the intraoperative blood loss
10 years
To assess the operating time
10 years
To assess the gastrointestinal function recovery
10 years
To assess the duration of hospital stay
10 years
To assess the reproductive outcomes
10 years
Interventions
The TrEnd is a single-institutional retrospective/prospective study, conducted in a high-volume referral centre for the endometriosis diagnosis and management, with the aim of systematically collecting data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis.
Eligibility Criteria
Women undergoing segmental sigmoid colon/rectal resection for deep endometriotic nodules infiltrating the tunica muscularis of the sigmoid colon/rectum preoperatively identified with imaging and surgically treated with segmental resection
You may qualify if:
- age \>/= 18 years;
- presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.
You may not qualify if:
- age \<18 years:
- presence of coexisting inflammatory bowel disease;
- patients who have received previous pelvic radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Casa Di Cura Malzoni Villa Platani Spa
Avellino, Campania, 83100, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Malzoni, MD
malzonimario@gmail.com
- PRINCIPAL INVESTIGATOR
Francesca Falcone, MD
francescafalcone@malzoni.org
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
April 23, 2024
First Posted
April 26, 2024
Study Start
October 11, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
April 26, 2024
Record last verified: 2024-04