Study Design


Study Design

This study is an observational prospective, international, multi-center, 4-parallel-cohorts study. Sites or surgeons can include patients in any cohort of the study for which they are qualified and in which they have passed the learning curve of 30 procedures.

Four cohorts will be the subject of study:
1. Robotic-assisted abdominal LAR/TME
2. Laparoscopic abdominal LAR/TME
3. Laparotomy LAR/TME
4. Transanal LAR/TME

It is not feasible to randomize patients to compare these techniques as not all centers have surgeons expert in all four techniques.

Once the number of necessary subjects is reached in the cohort, recruitment for this cohort will be stopped.
Parameters routinely recorded during TME surgery will be collected prospectively. All enrolled subjects will undergo assessments according the standard of care of each site. Data will be collected at the following intervals; pre-operative, operative, discharge, 30 days, 6 months, 1 year, and 2 years post–surgery. Depending on the sites standard of care the follow up visits will be performed as an inpatient hospital visit or telephone visit. A description of the study visits and required study procedures is included in the protocol.
There is no direct benefit and no additional risk for patients participating in this research. However, this research will provide clinical data on the medical care of rectal pathologies by robotic surgery.