Robotic Low Rectum Anterior Resection (GROG-R01)

January 16, 2024 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection

The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The laparoscopic approach for laparoscopic total mesorectal excision (L-TME) results improved short-term outcomes and provides a clearer intraoperative view compared with the open approach in a deep and narrow pelvis. Preliminary results from the COLOR II trial confirmed improved patient recovery and similar safety, same resection margins and completeness of resection using L-TME compared with the results achieved with open surgery.Results from the CLASICC trial supported the use of laparoscopic surgery for colorectal cancer and showed no difference between laparoscopically-assisted TME and conventional open resection at 10 years post-procedure in terms of overall survival, disease-free survival and local recurrence.

Despite these positive clinical outcomes for L-TME, laparoscopic resection of rectal cancer, especially in a deep and narrow pelvis, is technically demanding and demands a long learning curve. Technical limitations include limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. These limitations could explain the conversion rate which remained at 17% in the last COLOR II trial.2 In order to avoid this drawback, we have described for patients with high-risk of conversion, the trans-anal endoscopic proctectomy (TAEP) approach performed with the Transanal Endoscopic Operation (TEO) device.This trans-anal procedure is also called trans anal minimally invasive surgery (TAMIS) if a laparoscopic port is used.

Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity. However, total robotic surgery for rectal cancer is still technically challenging and involves two operative fields (splenic flexure and rectum), potential collision of the robotic arms and lack of tactile feedback.

Reports of robotic and laparoscopic rectal cancer surgery outcomes showed similar intraoperative results and morbidity, postoperative recovery and short-term oncologic outcomes.However, longer operation times have been described as a disadvantage of the robotic system, compared with conventional laparoscopy. On the other hand, all meta-analyses comparing robotic total mesorectal excision (R-TME) and L-TME concluded in reduction of the conversion rate.

Since 2007, the rectal surgery with robotic assistance is booming. To date, seven meta-analyzes have been published. All show that the robot exceeds laparoscopy to reduce the conversion rate. The last two meta-analyzes that had gathered more than 800 patients undergoing robotic surgery have again highlighted the contribution of the robot to secure the radial margin and decrease sexual sequelae. However, there is not so far from Phase 3 randomized trial dealing with the subject. The ROLARR protocol was completed in late 2014 (Ph III laparoscopy / Robot), the first results are published in late 2015.

The interest of a European multicenter ambispective (retrospective and prospective) database is fundamental because this early work suggests that the robot can make more for specific subgroups of patients, particularly in high surgical risk patients (Male, narrow pelvis, high BMI, mesorectal fat, large tumor of the anterior and middle third).

The largest series of R-TME stems from the US national cancer database (965 patients operated by R-TME) and confirms a 9.5% conversion rate compared to 16.4% with L-TME (p < 0.001).

Study Type

Interventional

Enrollment (Actual)

833

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • UCL
  • France
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75020
        • Hôpital Diaconesses
    • Bouches Du Rhône
      • Marseille, Bouches Du Rhône, France, 13003
        • Hôpital Européen
      • Marseille, Bouches Du Rhône, France, 13273
        • Institut Paoli Calmettes
    • Calvados
      • Caen, Calvados, France, 14000
        • Centre François Baclesse
    • Gard
      • Nîmes, Gard, France, 30900
        • Clinique Kennedy
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31000
        • Clinique Saint Jean du Languedoc
    • Haute Vienne
      • Limoges, Haute Vienne, France, 87042
        • CHU Dupuytren
    • Hauts De Seine
      • Antony, Hauts De Seine, France, 92160
        • Hôpital privé d'Anthony
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Institut Regional du Cancer de Montpellier
    • Isère
      • Grenoble, Isère, France, 38043
        • Hôpital Michalon
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • CHU de NANTES
      • Saint-Herblain, Loire Atlantique, France, 44805
        • Institut de Cancerologie de l'Ouest
    • Loiret
      • Orléans, Loiret, France, 45100
        • CHR Orleans
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54511
        • Chu de Nancy
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscart Lambret
    • Val De Marne
      • Villejuif, Val De Marne, France, 94800
        • Institut Gustave Roussy
  • Monaco
      • Monaco, Monaco, 98012
        • Centre Hospitalier-Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women ≥ 18 years
  2. Introducing rectal cancer, colorectal junction eligible to robotic surgery support from June 2015
  3. Treatment Naive for this cancer
  4. Enjoying a social protection scheme (For France only)
  5. Patient followed in the participant center

Exclusion Criteria:

  1. Male or female age (s) under 18 years
  2. Private person of liberty or under supervision (including guardianship)
  3. People who do not speak French (For France only)
  4. Major Nobody unable to consent
  5. Patient GROG-R01 already included in the base
  6. Patient Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinical database
Other: Clinical database
Creation of an ambispective (retrospective and prospective), multicentric and European clinical database for surgery with robotic assistance in rectal cancers with implementation in France and then in Europe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion rate for robotic surgery
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Anatomo-pathological curability criteria
Time Frame: 5 years
5 years
Median of hospitalization time
Time Frame: 5 years
5 years
Post-operative morbidity
Time Frame: 5 years
5 years
Number of robot docking
Time Frame: 5 years
5 years
Operating time
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Philippe Rouanet, MD, Institut Regional du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 5, 2020

Study Completion (Estimated)

February 5, 2025

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-BDD 2015/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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