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Recruiting NCT06386276

Surgical TReatment of Women With Deep ENDometriosis

Observational Deep Endometriosis Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colorectal bowel resection.
Who it may be relevant to
Registry conditions: Deep Endometriosis, Surgery. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection [Time frame: 10 years]
  • To assess the rate of complications [Time frame: 10 years]
  • To assess the rate of conversion to open surgery [Time frame: 10 years]
  • To assess the rate of endometriosis-free bowel resection margins [Time frame: 10 years]
  • To assess the rate of recurrence [Time frame: 10 years]
Secondary outcome measures (5)
  • To assess the intraoperative blood loss [Time frame: 10 years]
  • To assess the operating time [Time frame: 10 years]
  • To assess the gastrointestinal function recovery [Time frame: 10 years]
  • To assess the duration of hospital stay [Time frame: 10 years]
  • To assess the reproductive outcomes [Time frame: 10 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Casa Di Cura Malzoni Villa Platani Spa — Avellino

Identifiers

NCT: NCT06386276 · 00025986

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗