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Rectal Surgery Evaluation Trial (RESET) (RESET)

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ClinicalTrials.gov Identifier: NCT03574493
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
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.

Condition or disease Intervention/treatment
Rectal Cancer Procedure: TME with LAR

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: 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
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2023

Group/Cohort Intervention/treatment
Open laparotomy
A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.
Procedure: TME with LAR
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

Laparoscopic surgery
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
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

Robot-assisted surgery using the da Vinci® Surgical System
A minimally-invasive approach that allows good precision, flexibility, and control.
Procedure: TME with LAR
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

Transanal surgery through the anus
Where the protectomy is performed down to up until the Douglas pouch
Procedure: TME with LAR
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




Primary Outcome Measures :
  1. Efficacy of surgical method (success determined by composite of Oncologic, morbidity and functional outcomes) [ Time Frame: up to 4 years ]
    CRM, TME grade III, The absence of clavien dindo grade III-IV complications within 30 days post op



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
high- risk patients with mid-to-low rectal cancer
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
  3. High risk operative patients (two of these factors as assessed on MRI):

    1. Obese patient with a BMI > 30 (male or female)
    2. Narrow pelvis: inter-tuberous distance < 10 cm
    3. Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
    4. Expected coloanal or ultra-low colorectal anastomosis
  4. Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
  5. Patient has signed and dated the informed consent before inclusion in the study.

Exclusion Criteria:

  1. Patient with a comorbid illness or condition that would preclude the use of surgery.
  2. Patients with T4b tumors which impose a pelvectomy
  3. Patient requires an abdominal perineal resection (APR)
  4. Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
  5. Patient undergoing emergency procedures
  6. Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
  7. Metastatic disease
  8. Pregnant or suspected pregnancy
  9. Patients unwilling to comply with all follow-up study requirements
  10. Patient included in another study which impact on the surgical technique or its choice.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574493


Contacts
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Contact: Jean-Pierre Bleuse, MD +33467613102 jean-pierre.bleuse@icm.unicancer.fr

Locations
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France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Philippe Rouanet, MD, PhD    04-67-61-3071    prouanet@valdorel.fnclcc.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Intuitive Surgical
Investigators
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Principal Investigator: Philippe ROUANET, MD ICM
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT03574493    
Other Study ID Numbers: PROICM 2018-03 ORE
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
laparotomy
laparoscopy
low anterior resection
rectal cancer
robot assisted surgery
total mesorectal excision
transanal surgery
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases