Surgical TReatment of Women With Deep ENDometriosis

NCT ID: NCT06386276

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-11

Study Completion Date

2029-06-30

Brief Summary

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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

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Conditions

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Deep Endometriosis Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Francesca Falcone

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Malzoni, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Francesca Falcone, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Casa Di Cura Malzoni Villa Platani Spa

Avellino, Campania, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mario Malzoni, MD

Role: CONTACT

0825796111 ext. +39

Facility Contacts

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Francesca Falcone, MD

Role: primary

Other Identifiers

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00025986

Identifier Type: -

Identifier Source: org_study_id

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