Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy (PRORHEM)

Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial

Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.

During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).

Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Benign, Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenocarcinoma

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.

From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days

Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm

At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5

From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days

Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube

From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days

At post-operative hour 12, post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4, post-operative day 5 and post-operative day 7

Inclusion Criteria: Adult patients requiring elective minimally invasive RHC for polyps not amenable to endoscopic resection or for cTis-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure). Exclusion Criteria: Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach) Emergency surgery Hereditary colorectal cancer Inflammatory bowel disease Synchronous resection of (an)other organ(s) Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract) cT4 cM+ History of laparotomy Pregnancy No anastomosis planned Unable to provide informed consent No informed consent