Deep EndometriosisTrEndNCT06386276
Surgical TReatment of Women With Deep ENDometriosis
An observational study of Deep Endometriosis and Surgery, run by Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Deep Endometriosis, Surgery
- What is being tested?
- Colorectal bowel resection
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2023to 30 Jun 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Adult
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
Who may be able to join
- age >/= 18 years;
- presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.
Who cannot join
- age <18 years:
- presence of coexisting inflammatory bowel disease;
- patients who have received previous pelvic radiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Casa Di Cura Malzoni Villa Platani Spa
Avellino, Campania, 83100
Francesca Falcone, MD, francesca.falcone3@icloud.com
Mario Malzoni, MD
About this study
Official title: 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.
- Conditions
- Deep Endometriosis, Surgery
- Being tested
- Colorectal bowel resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal bowel resectionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection
Percentage
Measured: 10 years
To assess the rate of complications
Rate/percentage
Measured: 10 years
To assess the rate of conversion to open surgery
Rate/percentage
Measured: 10 years
To assess the rate of endometriosis-free bowel resection margins
Rate/percentage
Measured: 10 years
To assess the rate of recurrence
Rate/percentage
Measured: 10 years
Secondary outcomes (5)
To assess the intraoperative blood loss
Median with IQR
Measured: 10 years
To assess the operating time
Median time with IQR
Measured: 10 years
To assess the gastrointestinal function recovery
Median days with IQR
Measured: 10 years
To assess the duration of hospital stay
Median days with IQR
Measured: 10 years
To assess the reproductive outcomes
Rate/percentage of pregnancies, normal full term deliveries, spontaneous and voluntary abortions
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start11 Oct 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Falcone, Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
- Investigators
- Mario Malzoni, MD, Principal investigator, malzonimario@gmail.comFrancesca Falcone, MD, Principal investigator, francescafalcone@malzoni.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386276
- Sponsor's protocol ID
- 00025986
- Acronym
- TrEnd
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical TReatment of Women With Deep ENDometriosis Infiltrating the Sigmoid Colon and/or the Rectum. A Monocentric Archive
- ClinicalTrials.gov ID
- NCT06386276
- Acronym / sponsor ID
- TrEnd / 00025986
- Conditions
- Deep Endometriosis, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.University, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- age >/= 18 years;
- presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.
Key exclusion criteria (3 listed)
- age <18 years:
- presence of coexisting inflammatory bowel disease;
- patients who have received previous pelvic radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal bowel resectionThe 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. | Procedure or surgery | – |
Primary outcome
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection
Time frame: 10 years
Percentage
To assess the rate of complications
Time frame: 10 years
Rate/percentage
To assess the rate of conversion to open surgery
Time frame: 10 years
Rate/percentage
To assess the rate of endometriosis-free bowel resection margins
Time frame: 10 years
Rate/percentage
To assess the rate of recurrence
Time frame: 10 years
Rate/percentage
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis
Endometriosis, Deep Infiltrating Endometriosis
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Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
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3D Modeling of Deep Endometriosis From Pelvic MRI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Malzoni, MD principal investigator
malzonimario@gmail.com
Francesca Falcone, MD principal investigator
francescafalcone@malzoni.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Endometriosis and Surgery, run by Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Malzoni, MD (0825796111 ext. +39, malzonimario@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.