Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
- Conditions
- Colorectal Neoplasms MalignantColorectal Neoplasms, BenignColorectal PolypColorectal AdenocarcinomaColorectal NeoplasmsColorectal CancerColorectal Adenoma
- Registration Number
- NCT06067620
- Lead Sponsor
- Jeremy Meyer
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Adult patients requiring elective minimally invasive RHC for cT1-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to first passage of faeces From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days Measured in hours, starting at the skin closure of the index surgery
- Secondary Outcome Measures
Name Time Method Distal margin Within 10 days from the index surgical procedure Measured in centimeters, on the operative specimen of the index surgery
Quality of recovery 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 Quality of Recovery-15 (QoR-15) score
Blood loss From skin incision to skin closure, during index surgical procedure Measured in ml
Duration of surgery From skin incision to skin closure, during index surgical procedure Measured in minutes
Intra-operative transfusion From skin incision to skin closure, during index surgical procedure Number of patients who received blood and/or blood products transfusion
Intra-operative complication From skin incision to skin closure, during index surgical procedure Number of patients who experienced a complication during the index surgery
Creation of a stoma From skin incision to skin closure, during index surgical procedure Number of patients who received a stoma during the index surgery
Post-operative morbidity From index surgical procedure (skin closure) to post-operative day 30 Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale
Re-intervention From index surgical procedure (skin closure) to post-operative day 30 Number of patients who required a surgical re-intervention associated with the index surgery
Length of the extraction site At post-operative day 30 Measured in centimeters
Surgical site infection From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30 Number of patients who experienced surgical site infection
Mortality From index surgical procedure (skin closure) to post-operative day 30 Number of patients who experienced mortality
Proximal margin Within 10 days from the index surgical procedure Measured in centimeters, on the operative specimen of the index surgery
Harvested lymph nodes Within 10 days from the index surgical procedure Number of harvested lymph nodes, on the operative specimen of the index surgery
Conversion to open surgery From skin incision to skin closure, during index surgical procedure Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm
Hb, WBC and CRP At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5 Blood tests
Time to first passage of flatus From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days Measured in hours, starting at the skin closure of the index surgery
In-hospital postoperative ileus During hospitalisation, on average during the first 5 post-operative days Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube
Length of stay From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days Measured in days
Anastomotic leak From index surgical procedure (skin closure) to post-operative day 30 Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation
Histology of the tumor/polyp Within 10 days from the index surgical procedure Type of cancer and/or polyp, based on the operative specimen of the index surgery
TNM stage Within 10 days from the index surgical procedure 8th edition of the UICC TNM classification, based on the operative specimen of the index
Bowel function At post-operative day 30 and post-operative year 1 Gastrointestinal Quality of Life Index (GQLI)
Aesthetic numeric analogue scale (ANA-scale) At post-operative day 30 and post-operative year 1 Measuring the patient-reported esthetical aspect of the surgical wounds
Incidence of incisional hernia At post-operative year 1 Overall, and at extraction site; measured clinically and by CT