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NCT Number: NCT06386276

Surgical TReatment of Women With Deep ENDometriosis

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.

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Key information

Conditions

Deep Endometriosis Surgery

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Casa Di Cura Malzoni Villa Platani Spa

Avellino, Campania, 83100, Italy

Location status: Recruiting

Location contact

Francesca Falcone, MD

CONTACT

[email protected]

Francesca Falcone, MD

PRINCIPAL_INVESTIGATOR

Mario Malzoni, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colorectal bowel resection

Procedure

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 outcomes

  1. To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection

    Time frame: 10 years

    Percentage

  2. To assess the rate of complications

    Time frame: 10 years

    Rate/percentage

  3. To assess the rate of conversion to open surgery

    Time frame: 10 years

    Rate/percentage

  4. To assess the rate of endometriosis-free bowel resection margins

    Time frame: 10 years

    Rate/percentage

  5. To assess the rate of recurrence

    Time frame: 10 years

    Rate/percentage

Secondary outcomes

  1. To assess the intraoperative blood loss

    Time frame: 10 years

    Median with IQR

  2. To assess the operating time

    Time frame: 10 years

    Median time with IQR

  3. To assess the gastrointestinal function recovery

    Time frame: 10 years

    Median days with IQR

  4. To assess the duration of hospital stay

    Time frame: 10 years

    Median days with IQR

  5. To assess the reproductive outcomes

    Time frame: 10 years

    Rate/percentage of pregnancies, normal full term deliveries, spontaneous and voluntary abortions

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Malzoni, MD

CONTACT

[email protected]

0825796111 ext. +39

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: TrEnd

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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