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Surgical TReatment of Women With Deep ENDometriosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06386276
Acronym
TrEnd
Enrollment
250
Registered
2024-04-26
Start date
2023-10-11
Completion date
2029-06-30
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Endometriosis, Surgery

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.

Interventions

PROCEDUREColorectal 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.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
To assess the rate of recurrence10 yearsRate/percentage
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection10 yearsPercentage
To assess the rate of complications10 yearsRate/percentage
To assess the rate of conversion to open surgery10 yearsRate/percentage
To assess the rate of endometriosis-free bowel resection margins10 yearsRate/percentage

Secondary

MeasureTime frameDescription
To assess the intraoperative blood loss10 yearsMedian with IQR
To assess the operating time10 yearsMedian time with IQR
To assess the gastrointestinal function recovery10 yearsMedian days with IQR
To assess the duration of hospital stay10 yearsMedian days with IQR
To assess the reproductive outcomes10 yearsRate/percentage of pregnancies, normal full term deliveries, spontaneous and voluntary abortions

Countries

Italy

Contacts

Primary ContactMario Malzoni, MD
malzonimario@gmail.com0825796111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026