Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Procedure: Robotic right hemicolectomy
* Procedure: Laparoscopic right hemicolectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic right hemicolectomy<br>Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy) | Procedure: Robotic right hemicolectomy<br>* Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.<br>|
| Active Comparator: Laparoscopic right hemicolectomy<br>Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care) | Procedure: Laparoscopic right hemicolectomy<br>* Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first passage of faeces | Measured in hours, starting at the skin closure of the index surgery | From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Measured in minutes | From skin incision to skin closure, during index surgical procedure | 
| Blood loss | Measured in ml | From skin incision to skin closure, during index surgical procedure | 
| Intra-operative transfusion | Number of patients who received blood and/or blood products transfusion | From skin incision to skin closure, during index surgical procedure | 
| Intra-operative complication | Number of patients who experienced a complication during the index surgery | 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 | From skin incision to skin closure, during index surgical procedure | 
| Length of the extraction site | Measured in centimeters | At post-operative day 30 | 
| Creation of a stoma | Number of patients who received a stoma during the index surgery | From skin incision to skin closure, during index surgical procedure | 
| Hb, WBC and CRP | Blood tests | 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 | 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 | During hospitalisation, on average during the first 5 post-operative days | 
| Length of stay | Measured in days | 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 | From index surgical procedure (skin closure) to post-operative day 30 | 
| Surgical site infection | Number of patients who experienced surgical site infection | 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 | 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 | From index surgical procedure (skin closure) to post-operative day 30 | 
| Mortality | Number of patients who experienced mortality | From index surgical procedure (skin closure) to post-operative day 30 | 
| Proximal margin | Measured in centimeters, on the operative specimen of the index surgery | Within 10 days from the index surgical procedure | 
| Distal margin | Measured in centimeters, on the operative specimen of the index surgery | Within 10 days from the index surgical procedure | 
| Harvested lymph nodes | Number of harvested lymph nodes, on the operative specimen of the index surgery | 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 | 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 | Within 10 days from the index surgical procedure | 
| Bowel function | Gastrointestinal Quality of Life Index (GQLI) | At post-operative day 30 and post-operative year 1 | 
| Quality of recovery | Quality of Recovery-15 (QoR-15) score | 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 | At post-operative day 30 and post-operative year 1 | 
| Incidence of incisional hernia | Overall, and at extraction site; measured clinically and by CT | At post-operative year 1 |