Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

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.

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Robotic right hemicolectomy

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

Group Type EXPERIMENTAL

Robotic right hemicolectomy

Intervention Type PROCEDURE

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

Laparoscopic right hemicolectomy

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

Group Type ACTIVE_COMPARATOR

Laparoscopic right hemicolectomy

Intervention Type PROCEDURE

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Interventions

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Robotic right hemicolectomy

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

Intervention Type PROCEDURE

Laparoscopic right hemicolectomy

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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).

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No