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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.
Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.
Time to first passage of faeces
Measured in hours, starting at the skin closure of the index surgery
Time frame: From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days
Duration of surgery
Measured in minutes
Time frame: From skin incision to skin closure, during index surgical procedure
Blood loss
Measured in ml
Time frame: From skin incision to skin closure, during index surgical procedure
Intra-operative transfusion
Number of patients who received blood and/or blood products transfusion
Time frame: From skin incision to skin closure, during index surgical procedure
Intra-operative complication
Number of patients who experienced a complication during the index surgery
Time frame: From skin incision to skin closure, during index surgical procedure
Conversion to open surgery
Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm
Time frame: From skin incision to skin closure, during index surgical procedure
Length of the extraction site
Measured in centimeters
Time frame: At post-operative day 30
Creation of a stoma
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Number of patients who received a stoma during the index surgery
Time frame: From skin incision to skin closure, during index surgical procedure
Hb, WBC and CRP
Blood tests
Time frame: At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5
Time to first passage of flatus
Measured in hours, starting at the skin closure of the index surgery
Time frame: From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days
In-hospital postoperative ileus
Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube
Time frame: During hospitalisation, on average during the first 5 post-operative days
Length of stay
Measured in days
Time frame: From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days
Post-operative morbidity
Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale
Time frame: From index surgical procedure (skin closure) to post-operative day 30
Surgical site infection
Number of patients who experienced surgical site infection
Time frame: From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30
Anastomotic leak
Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation
Time frame: From index surgical procedure (skin closure) to post-operative day 30
Re-intervention
Number of patients who required a surgical re-intervention associated with the index surgery
Time frame: From index surgical procedure (skin closure) to post-operative day 30
Mortality
Number of patients who experienced mortality
Time frame: From index surgical procedure (skin closure) to post-operative day 30
Proximal margin
Measured in centimeters, on the operative specimen of the index surgery
Time frame: Within 10 days from the index surgical procedure
Distal margin
Measured in centimeters, on the operative specimen of the index surgery
Time frame: Within 10 days from the index surgical procedure
Harvested lymph nodes
Number of harvested lymph nodes, on the operative specimen of the index surgery
Time frame: Within 10 days from the index surgical procedure
Histology of the tumor/polyp
Type of cancer and/or polyp, based on the operative specimen of the index surgery
Time frame: Within 10 days from the index surgical procedure
TNM stage
8th edition of the UICC TNM classification, based on the operative specimen of the index
Time frame: Within 10 days from the index surgical procedure
Bowel function
Gastrointestinal Quality of Life Index (GQLI)
Time frame: At post-operative day 30 and post-operative year 1
Quality of recovery
Quality of Recovery-15 (QoR-15) score
Time frame: 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
Aesthetic numeric analogue scale (ANA-scale)
Measuring the patient-reported esthetical aspect of the surgical wounds
Time frame: At post-operative day 30 and post-operative year 1
Incidence of incisional hernia
Overall, and at extraction site; measured clinically and by CT
Time frame: At post-operative year 1