Surgical TReatment of Women With Deep ENDometriosis

Recruiting

• Conditions: Deep Endometriosis; Surgery

• Registration Number: NCT06386276
• Lead Sponsor: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the rate of recurrence	10 years	Rate/percentage
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection	10 years	Percentage
To assess the rate of conversion to open surgery	10 years	Rate/percentage
To assess the rate of endometriosis-free bowel resection margins	10 years	Rate/percentage
To assess the rate of complications	10 years	Rate/percentage

Secondary Outcome Measures

Name	Time	Method
To assess the duration of hospital stay	10 years	Median days with IQR
To assess the operating time	10 years	Median time with IQR
To assess the gastrointestinal function recovery	10 years	Median days with IQR
To assess the reproductive outcomes	10 years	Rate/percentage of pregnancies, normal full term deliveries, spontaneous and voluntary abortions
To assess the intraoperative blood loss	10 years	Median with IQR

Trial Locations

Locations (1)

Casa Di Cura Malzoni Villa Platani Spa; 🇮🇹 Avellino, Campania, Italy