Trials / Not Yet Recruiting
Not Yet RecruitingNCT06067620
Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Jeremy Meyer · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Colorectal Neoplasms
- Colorectal Neoplasms Malignant
- Colorectal Neoplasms, Benign
- Colorectal Cancer
- Colorectal Polyp
- Colorectal Adenoma
- Colorectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Robotic right hemicolectomy | Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi. |
| PROCEDURE | Laparoscopic right hemicolectomy | Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline. |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2026-08-01
- Completion
- 2026-12-31
- First posted
- 2023-10-05
- Last updated
- 2024-05-10
Source: ClinicalTrials.gov record NCT06067620. Inclusion in this directory is not an endorsement.