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Robotic Low Rectum Anterior Resection (GROG-R01)

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ClinicalTrials.gov Identifier: NCT04015804
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectum Cancer Other: Clinical database Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2025

Arm Intervention/treatment
Experimental: 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




Primary Outcome Measures :
  1. Conversion rate for robotic surgery [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Anatomo-pathological curability criteria [ Time Frame: 5 years ]
  2. Median of hospitalization time [ Time Frame: 5 years ]
  3. Post-operative morbidity [ Time Frame: 5 years ]
  4. Number of robot docking [ Time Frame: 5 years ]
  5. Operating time [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04015804


Contacts
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Contact: Jean-Pierre Bleuse, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr

Locations
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Belgium
UCL Recruiting
Bruxelles, Belgium
Contact: Alex Kharteuse, MD       alex.kartheuser@uclouvain.be   
France
Hôpital Européen Recruiting
Marseille, Bouches Du Rhône, France, 13003
Contact: Régis Fara, MD    4 13 427 240 ext +33    regis.fara@gmail.com   
Institut Paoli Calmettes Recruiting
Marseille, Bouches Du Rhône, France, 13273
Contact: Bernard Lelong, MD    4 91 22 33 33 ext +33    lelongb@ipc.unicancer.fr   
Centre François Baclesse Recruiting
Caen, Calvados, France, 14000
Contact: Emmanuel Polycarpe, MD    2 31 45 55 07 ext +33    e.polycarpe@baclesse.unicancer.fr   
Clinique Kennedy Recruiting
Nîmes, Gard, France, 30900
Contact: David Amielh, MD    4 66 62 27 72 ext +33    nemaudig@gmail.com   
Clinique Saint Jean du Languedoc Recruiting
Toulouse, Haute Garonne, France, 31000
Contact: Arnault Béliard, MD    5 61 54 95 84 ext +33    abeliard@capio.fr   
CHU Dupuytren Recruiting
Limoges, Haute Vienne, France, 87042
Contact: Muriel Mathonnet, MD       muriel.mathonnet@chu-limoges.fr   
Hôpital privé d'Anthony Recruiting
Antony, Hauts De Seine, France, 92160
Contact: Jean-Marc Thillois, MD    1 46 74 41 62 ext +33    docteur.thillois@gmail.com   
Institut régional du cancer de Montpellier Recruiting
Montpellier, Hérault, France, 34298
Contact: Philippe Rouanet, MD    4 67 61 30 71 ext +33    philippe.rouanet@icm.unicancer.fr   
Hôpital Michalon Recruiting
Grenoble, Isère, France, 38043
Contact: Jean-Luc Faucheron, MD       jlfaucheron@chu-grenoble.fr   
CHU de Nantes Recruiting
Nantes, Loire Atlantique, France, 44093
Contact: Guillaume Meurette, MD    2 40 08 30 22 ext +33    guillaume.meurette@chu-nantes.fr   
Institut de Cancérologie de l'Ouest Recruiting
Saint-Herblain, Loire Atlantique, France, 44805
Contact: Frédéric Dumont, MD       frederic.dumont@ico.unicancer.fr   
CHR Orléans Recruiting
Orléans, Loiret, France, 45100
Contact: Arnaud Piquard, MD       arnaud.piquard@chr-orleans.fr   
CHU de Nancy Recruiting
Vandœuvre-lès-Nancy, Lorraine, France, 54511
Contact: Laurent Bresler, MD    3 83 15 31 10 ext +33    l.bresler@chu-nancy.fr   
Centre Oscart Lambret Recruiting
Lille, Nord, France, 59000
Contact: Mehrdad Jafari, MD       m-jafari@o-lambret.fr   
Institut Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94800
Contact: Leonor Benhaim, MD       goere@igr.fr   
Hôpital Diaconesses Recruiting
Paris, France, 75020
Contact: Alain Valverde, MD       avalverde@hopital-dcss.org   
Hôpital européen Georges Pompidou Recruiting
Paris, France, 75908
Contact: Richard Douard, MD    1 56 09 30 22 ext +33    richard.douard@egp.aphp.fr   
Monaco
Centre Hospitalier-Princesse Grace Recruiting
Monaco, Monaco, 98012
Contact: Hubert Perrin, MD       hperrin@chpg.mc   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Philippe Rouanet, MD Institut régional du cancer de Montpellier

Additional Information:
Publications:

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04015804     History of Changes
Other Study ID Numbers: ICM-BDD 2015/05
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
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:
cancer
rectum
robot
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