title: A multicentre randomised controlled trial to evaluate the efficacy, morbidity and functional outcome of endoscopic transanal proctectomy versus laparoscopic proctectomy for low-lying rectal cancer (ETAP-GRECCAR 11 TRIAL): rationale and design.
abstract: Total mesorectal excision is the standard surgical treatment for mid- and low-rectal cancer. Laparoscopy represents a clear leap forward in the management of rectal cancer patients, offering significant improvements in post-operative measures such as pain, first bowel movement, and hospital length of stay. However, there are still some limits to its applications, especially in difficult cases. Such cases may entail either conversion to an open procedure or positive resection margins. Transanal endoscopic proctectomy (ETAP) was recently described and could address the difficulties of approaching the lower third of the rectum. Early series and case-control studies have shown favourable short-term results, such as a low conversion rate, reduced hospital length of stay and oncological outcomes comparable to laparoscopic surgery. The aim of the proposed study is to compare the rate of positive resection margins (R1 resection) with ETAP versus laparoscopic proctectomy (LAP), with patients randomly assigned to each arm.
  
  
  
  The proposed study is a multicentre randomised trial using two parallel groups to compare ETAP and LAP. Patients with T3 lower-third rectal adenocarcinomas for whom conservative surgery with manual coloanal anastomosis is planned will be recruited. Randomisation will be performed immediately prior to surgery after ensuring that the patient meets the inclusion criteria and completing the baseline functional and quality of life tests. The study is designed as a non-inferiority trial with a main criterion of R0/R1 resection. Secondary endpoints will include the conversion rate, the minimal invasiveness of the abdominal approach, postoperative morbidity, the length of hospital stay, mesorectal macroscopic assessment, functional urologic and sexual results, faecal continence, global quality of life, stoma-free survival, and disease-free survival at 3 years. The inclusion period will be 3 years, and every patient will be followed for 3 years. The number of patients needed is 226.
  
  
  
  There is a strong need for optimal evaluation of the ETAP because of substancial changes in the operative technique. Assessment of oncological safety and septic risk, as well as digestive and urological functional results, is particularily mandatory. Moreover, benefits of the ETAP technique could be demonstrated  in post-operative outcome.
  
  
  
  ClinicalTrial.gov: NCT02584985 . Date and version identifier: Version n°2 - 2015 July 6.
authors.affiliation: Department of Digestive Surgical Oncology, Department of Mini Invasive Interventions (DIMI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France. lelongb@ipc.unicancer.fr.
authors.forename: Bernard
authors.initials: B
authors.lastname: Lelong
authors.affiliation: Department of Digestive Surgical Oncology, Department of Mini Invasive Interventions (DIMI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: de Chaisemartin
authors.affiliation: Department of Digestive Surgical Oncology, Department of Mini Invasive Interventions (DIMI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Helene
authors.initials: H
authors.lastname: Meillat
authors.affiliation: Department of Clinical Research and Innovation (DRCI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Sandra
authors.initials: S
authors.lastname: Cournier
authors.affiliation: Department of Biostatistics and Methodology, Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Jean Marie
authors.initials: JM
authors.lastname: Boher
authors.affiliation: Department of Clinical Research and Innovation (DRCI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Genre
authors.affiliation: Department of Digestive Surgery, CHU Pitié-Salpetriere, Paris, France.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Karoui
authors.affiliation: Department of Digestive Surgery, CHU Charles Nicolle, Rouen, France.
authors.forename: Jean Jacques
authors.initials: JJ
authors.lastname: Tuech
authors.affiliation: Department of Digestive Surgical Oncology, Department of Mini Invasive Interventions (DIMI), Paoli Calmettes Institute, Comprehensive Cancer Centre, Marseille, France.
authors.forename: Jean Robert
authors.initials: JR
authors.lastname: Delpero
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology* / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D020127:Recovery of Function; D012004:Rectal Neoplasms / Q000473:pathology* / Q000601:surgery; D012107:Research Design; D013997:Time Factors; D000067368:Transanal Endoscopic Surgery / Q000379:methods*; D055815:Young Adult
keywords: Minimally invasive; Rectal cancer; Transanal approach