Surgical TReatment of Women With Deep ENDometriosis

Surgery Clinical Trial

— TrEnd  

Official title:

Surgical TReatment of Women With Deep ENDometriosis Infiltrating the Sigmoid Colon and/or the Rectum. A Monocentric Archive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386276
• Other study ID #: 00025986
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: April 2024
• Source: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
• Contact: Mario Malzoni, MD
• Phone: 0825796111
• Email: malzonimario[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis
• Surgery

Intervention

Procedure:
• Colorectal bowel resection
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.

Locations

Country	Name	City	State
Italy	Casa Di Cura Malzoni Villa Platani Spa	Avellino	Campania

Sponsors (1)

Lead Sponsor	Collaborator
Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection	Percentage	10 years
Primary	To assess the rate of complications	Rate/percentage	10 years
Primary	To assess the rate of conversion to open surgery	Rate/percentage	10 years
Primary	To assess the rate of endometriosis-free bowel resection margins	Rate/percentage	10 years
Primary	To assess the rate of recurrence	Rate/percentage	10 years
Secondary	To assess the intraoperative blood loss	Median with IQR	10 years
Secondary	To assess the operating time	Median time with IQR	10 years
Secondary	To assess the gastrointestinal function recovery	Median days with IQR	10 years
Secondary	To assess the duration of hospital stay	Median days with IQR	10 years
Secondary	To assess the reproductive outcomes	Rate/percentage of pregnancies, normal full term deliveries, spontaneous and voluntary abortions	10 years