Surgical TReatment of Women With Deep ENDometriosis Infiltrating the Sigmoid Colon and/or the Rectum. A Monocentric Archive
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Deep Endometriosis
- Sponsor
- Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- To assess the rate of recurrence
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Francesca Falcone
Medical Doctor
Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
Eligibility Criteria
Inclusion Criteria
- •age \>/= 18 years;
- •presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.
Exclusion Criteria
- •age \<18 years:
- •presence of coexisting inflammatory bowel disease;
- •patients who have received previous pelvic radiotherapy.
Outcomes
Primary Outcomes
To assess the rate of recurrence
Time Frame: 10 years
Rate/percentage
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection
Time Frame: 10 years
Percentage
To assess the rate of conversion to open surgery
Time Frame: 10 years
Rate/percentage
To assess the rate of endometriosis-free bowel resection margins
Time Frame: 10 years
Rate/percentage
To assess the rate of complications
Time Frame: 10 years
Rate/percentage
Secondary Outcomes
- To assess the operating time(10 years)
- To assess the gastrointestinal function recovery(10 years)
- To assess the reproductive outcomes(10 years)
- To assess the intraoperative blood loss(10 years)
- To assess the duration of hospital stay(10 years)