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RecruitingNCT06386276TrEndUpdated Apr 26, 2024

Surgical TReatment of Women With Deep ENDometriosis

An observational study in Deep Endometriosis and Surgery, sponsored by Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. · Observational

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
250
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

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Conditions studied

  • Deep Endometriosis
  • Surgery

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In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 250 is above the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

This is the only study on the registry with Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
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

Inclusion criteria

  • age >/= 18 years;
  • presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.

Exclusion criteria

Exclusion Criteria:

  • age \<18 years:
  • presence of coexisting inflammatory bowel disease;
  • patients who have received previous pelvic radiotherapy.
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
250 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

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.

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What researchers measure

Primary outcomes

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

    Percentage

    Time frame: 10 years

  2. To assess the rate of complications

    Rate/percentage

    Time frame: 10 years

  3. To assess the rate of conversion to open surgery

    Rate/percentage

    Time frame: 10 years

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

    Rate/percentage

    Time frame: 10 years

  5. To assess the rate of recurrence

    Rate/percentage

    Time frame: 10 years

Secondary outcomes

  1. To assess the intraoperative blood loss

    Median with IQR

    Time frame: 10 years

  2. To assess the operating time

    Median time with IQR

    Time frame: 10 years

  3. To assess the gastrointestinal function recovery

    Median days with IQR

    Time frame: 10 years

  4. To assess the duration of hospital stay

    Median days with IQR

    Time frame: 10 years

  5. To assess the reproductive outcomes

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

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
  • Casa Di Cura Malzoni Villa Platani Spa
    Avellino, Campania 83100, Italy
    • Francesca Falcone, MD · Contact · francesca.falcone3@icloud.com
    • Mario Malzoni, MD · Principal investigator
    • Francesca Falcone, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06386276
Lead sponsor
Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
Responsible party
Francesca Falcone (Medical Doctor, Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.) — Principal investigator
First posted
Apr 26, 2024
Start date
Oct 11, 2023
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Apr 26, 2024

Study contacts

Mario Malzoni, MD
Contact
malzonimario@gmail.com
0825796111 ext. +39
Mario Malzoni, MD
principal investigator · malzonimario@gmail.com
Francesca Falcone, MD
principal investigator · francescafalcone@malzoni.org

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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