Rectal Surgery Evaluation Trial (RESET)

Study Overview
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Brief Summary
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Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

Detailed Description
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The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique. Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, TME grade III, and minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions.

Official Title
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Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: TME with LAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure High risk operative patients (two of these factors as assessed on MRI): Obese patient with a BMI > 30 (male or female) Narrow pelvis: inter-tuberous distance < 10 cm Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis Expected coloanal or ultra-low colorectal anastomosis Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2) Patient has signed and dated the informed consent before inclusion in the study. Exclusion Criteria: Patient with a comorbid illness or condition that would preclude the use of surgery. Patients with T4b tumors which impose a pelvectomy Patient requires an abdominal perineal resection (APR) Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment Patient undergoing emergency procedures Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections) Metastatic disease Pregnant or suspected pregnancy Patients unwilling to comply with all follow-up study requirements Patient included in another study which impact on the surgical technique or its choice.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open laparotomy<br>A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity. | Procedure: TME with LAR<br>* Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME<br>|
| Laparoscopic surgery<br>A minimally-invasive technique in which operations are performed via small incisions (usually 0.5-1.5 cm) at a location distant to the site of interest. | Procedure: TME with LAR<br>* Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME<br>|
| Robot-assisted surgery using the da Vinci® Surgical System<br>A minimally-invasive approach that allows good precision, flexibility, and control. | Procedure: TME with LAR<br>* Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME<br>|
| Transanal surgery through the anus<br>Where the protectomy is performed down to up until the Douglas pouch | Procedure: TME with LAR<br>* Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of surgical method (success determined by composite of Oncologic, morbidity and functional outcomes) | CRM, TME grade III, The absence of clavien dindo grade III-IV complications within 30 days post op | up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparotomy, laparoscopy, low anterior resection, rectal cancer, robot assisted surgery, total mesorectal excision, transanal surgery