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GROG-R01: Robotic Low Rectum Anterior Resection

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04015804
Collaborator
(none)
833
Enrollment
19
Locations
1
Arm
120
Anticipated Duration (Months)
43.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Clinical database
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
833 participants
Allocation:
N/A
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 :
Mar 1, 2015
Actual Primary Completion Date :
Oct 15, 2018
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Conversion rate for robotic surgery [5 years]

Secondary Outcome Measures

  1. Anatomo-pathological curability criteria [5 years]

  2. Median of hospitalization time [5 years]

  3. Post-operative morbidity [5 years]

  4. Number of robot docking [5 years]

  5. Operating time [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCL Bruxelles Belgium
2 Hôpital Européen Marseille Bouches Du Rhône France 13003
3 Institut Paoli Calmettes Marseille Bouches Du Rhône France 13273
4 Centre François Baclesse Caen Calvados France 14000
5 Clinique Kennedy Nîmes Gard France 30900
6 Clinique Saint Jean du Languedoc Toulouse Haute Garonne France 31000
7 CHU Dupuytren Limoges Haute Vienne France 87042
8 Hôpital privé d'Anthony Antony Hauts De Seine France 92160
9 Institut régional du cancer de Montpellier Montpellier Hérault France 34298
10 Hôpital Michalon Grenoble Isère France 38043
11 CHU de Nantes Nantes Loire Atlantique France 44093
12 Institut de Cancérologie de l'Ouest Saint-Herblain Loire Atlantique France 44805
13 CHR Orléans Orléans Loiret France 45100
14 CHU de Nancy Vandœuvre-lès-Nancy Lorraine France 54511
15 Centre Oscart Lambret Lille Nord France 59000
16 Institut Gustave Roussy Villejuif Val De Marne France 94800
17 Hôpital Diaconesses Paris France 75020
18 Hôpital européen Georges Pompidou Paris France 75908
19 Centre Hospitalier-Princesse Grace Monaco Monaco 98012

Sponsors and Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Philippe Rouanet, MD, Institut régional du cancer de Montpellier

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT04015804
Other Study ID Numbers:
  • ICM-BDD 2015/05
First Posted:
Jul 11, 2019
Last Update Posted:
Nov 4, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Rectal Neoplasms

Study Results

No Results Posted as of Nov 4, 2021