Surgical TReatment of Women With Deep ENDometriosis (TrEnd)

April 23, 2024 updated by: Francesca Falcone, Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • Recruiting
        • Casa Di Cura Malzoni Villa Platani Spa
        • Contact:
        • Principal Investigator:
          • Mario Malzoni, MD
        • Principal Investigator:
          • Francesca Falcone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women undergoing segmental sigmoid colon/rectal resection for deep endometriotic nodules infiltrating the tunica muscularis of the sigmoid colon/rectum preoperatively identified with imaging and surgically treated with segmental resection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Mario Malzoni, MD, malzonimario@gmail.com
  • Principal Investigator: Francesca Falcone, MD, francescafalcone@malzoni.org

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00025986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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