Surgical TReatment of Women With Deep ENDometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorCasa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age >/= 18 years;
presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.
Disqualifiers
presence of coexisting inflammatory bowel disease;
patients who have received previous pelvic radiotherapy.
Trial 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
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Colorectal bowel resection
Procedure/SurgeryThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
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 years2
To assess the rate of complications
Rate/percentage
Time frame
10 years3
To assess the rate of conversion to open surgery
Rate/percentage
Time frame
10 years4
To assess the rate of endometriosis-free bowel resection margins
Rate/percentage
Time frame
10 yearsSecondary outcomes
1
To assess the intraoperative blood loss
Median with IQR
Time frame
10 years2
To assess the operating time
Median time with IQR
Time frame
10 years3
To assess the gastrointestinal function recovery
Median days with IQR
Time frame
10 years4
To assess the duration of hospital stay
Median days with IQR
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov