SNFGE SNFGE
 
Thématique :
- Coloproctologie
Originalité :
Très original
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Professeur Frank ZERBIB
Coup de coeur :
 
 
Journal of the American Medical Association (JAMA)
  2017/10  
 
  2017 Oct ;318(16):1569-1580.  
  doi: 10.1001/jama.2017.7219.  
 
  Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer The ROLARR Randomized Clinical Trial  
 
  Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J  
  https://www.ncbi.nlm.nih.gov/pubmed/29067426  
 
 

Abstract

IMPORTANCE:

Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy.

OBJECTIVE:

To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer.

DESIGN, SETTING, AND PARTICIPANTS:

Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015.

INTERVENTIONS:

Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum).

MAIN OUTCOMES AND MEASURES:

The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes.

RESULTS:

Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, -1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, -3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups.

CONCLUSIONS AND RELEVANCE:

Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection.

 

 
Question posée
 
La chirurgie assistée d’un robot apporte-t-elle un bénéfice dans le cancer du rectum ?
 
Question posée
 
Absence de différence significative avec et sans robot en termes de conversions en laparotomie, marges circonférentielles envahies, complications et séquelles fonctionnelles.
 
Commentaires

On sentait bien l’effet de mode et l’intérêt financier, mais cette fois c’est démontré de manière claire (471 malades randomisés, 40 chirurgiens dans 10 pays).

 
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