Clinical trial NCT04015804: Robotic Low Rectum Anterior Resection
Official title: European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectum Cancer
Keywords: cancer
rectum
robot
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility 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

Primary outcomes:
measure: Conversion rate for robotic surgery
timeFrame: 5 years
Secondary outcomes:
measure: Anatomo-pathological curability criteria
timeFrame: 5 years
measure: Median of hospitalization time
timeFrame: 5 years
measure: Post-operative morbidity
timeFrame: 5 years
measure: Number of robot docking
timeFrame: 5 years
measure: Operating time
timeFrame: 5 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCL
city: Marseille
country: France
facility: Hôpital Européen
state: Bouches Du Rhône
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhône
city: Caen
country: France
facility: Centre François Baclesse
state: Calvados
city: Nîmes
country: France
facility: Clinique Kennedy
state: Gard
city: Toulouse
country: France
facility: Clinique Saint Jean du Languedoc
state: Haute Garonne
city: Limoges
country: France
facility: CHU Dupuytren
state: Haute Vienne
city: Antony
country: France
facility: Hôpital privé d'Anthony
state: Hauts De Seine
city: Montpellier
country: France
facility: Institut régional du cancer de Montpellier
state: Hérault
city: Grenoble
country: France
facility: Hôpital Michalon
state: Isère
city: Nantes
country: France
facility: CHU de Nantes
state: Loire Atlantique
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
state: Loire Atlantique
city: Orléans
country: France
facility: CHR Orléans
state: Loiret
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy
state: Lorraine
city: Lille
country: France
facility: Centre Oscart Lambret
state: Nord
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Paris
country: France
facility: Hôpital Diaconesses
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Monaco
country: Monaco
facility: Centre Hospitalier-Princesse Grace
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: Philippe Rouanet, MD
role: STUDY_CHAIR
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