Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy vs Standard Transabdominal Laparoscopic Proctectomy for Rectal Cancer

Sponsor
Institut Paoli-Calmettes
Study ID
NCT02584985
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ETAP — PROCEDURE
    Primary transanal endoscopic approach, secondary transabdominal laparoscopic approach
  • Standard Transabdominal Laparoscopic Proctectomy — PROCEDURE
    Primary transabdominal laparoscopic approach

Study Details

Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME). Originally performed by open surgery, TME demonstrated improved local control and reduced urogenital morbidity. Laparoscopic approach has been validated by several randomised controlled trials: laparoscopic approach offers to the patient a better post-operative recovery, a lower risk of wound hernia and comparable oncological results. However, the risk of conversion to open procedure remains significant. Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole pelvic dissection via a specific-moderate cost device. The procedure is then completed by a briefer transabdominal laparoscopic step to mobilise the colon and perform inferior mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this approach is to perform a surgical dissection via an extra peritoneal route, without peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This approach offer closer and better exposure of pelvic dissection plane and could improve oncological quality and pelvic nerve preservation. It could be profitable to postoperative patient outcome. However rates and type of cancer-recurrences as well as functional results have to be assessed in a controlled study. This technique has shown to be feasible and reproducible through early clinical series. Conversion rates appear to be lower than published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of morbidity (27.8%), R1 resection\* (6%), mesorectum macroscopic integrity (100%) appear to be comparable to laparoscopic approach results. However functional results as well as urologic morbidity have to be evaluated in comparative studies. In a preliminary retrospective comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs 10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038). Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2 80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date, Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including several short series demonstrating the feasibility of the technique and showing low morbidity. For some authors the benefit of transanal approach is significant in difficult cases such as male patient and narrow pelvis. Very recently, two non randomised comparative studies were published with conclusions close to those in our study. Investigators propose, with the support of the GRECCAR group, to conduct a national, multicenter, open-label randomized study based on oncological non-inferiority (R1 resection rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual colo-anal anastomosis. There is a clear expected benefit expected for the patients through the ETAP procedure in term of post operative short term outcome, risk of conversion to open procedure, risk of wound hernia.This trial could also show significant advantages in terms of quality of dissection, quality of the specimen, quality of nerve preservation.

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2026
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: ETAP : Endoscopic Transanal Proctectomy
    1. Primary transanal approach : Careful positioning in Lithtomy, dilatation and anal exposure with standard retractor. Mucosa incision and internal sphincter dissection according to tumor extension. Primary conventional dissection up to circumferential exposure of fascia recti. Secondary implantation of transanal endoscopic device Begin mesorectal endoscopic dissection postero-anteriorly, then laterally with nerve-sparing dissection. Level assessment of posterior dissection (vertical segment). End with peritoneal opening anteriorly (Douglas). 2. Secondary transabdominal approach : Type of laparoscopic approach multiport or singleport. Level of arterial section, extension of colonic mobilization, site for specimen extraction (transanal / transabdominal), type of colonic reconstruction.
  • Other: Standard Transabdominal Laparoscopic proctectomy
    Primary transanal conventional dissection (sphincter preservation assessment) or not, type of laparoscopic approach multiport or singleport, level of arterial section, extension of colonic mobilization, conditions of mesorectal excision and nerve preservation, site for specimen extraction (transanal / transabdominal) and type of colonic reconstruction.

Primary Outcome Measure

R1 resection rate [ Time Frame: from surgery up to 3 years ]

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