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RECRUITING
NCT05829343

RObotic Versus LAparoscopic Colectomy for DIverticulitis.

Sponsor: S.M. Misericordia Hospital

View on ClinicalTrials.gov

Summary

Over the last decade there has been a growing interest toward the application of robotic approach for diverticular disease. The evidence available on the literature showed that robotic approach, compared to the laparoscopic surgery, offers significant advantages in terms of conversion rate and shortened hospital stay for the treatment of diverticular disease. The investigators aimed at evaluating whether robotic colectomy may offer some advantages over the laparoscopic approach for surgical treatment of diverticular disease by analyzing a one year multicenter prospective study. Primary objective is to evaluate if robotic approach reduce the rate of conversion to open approach compared to laparoscopic surgery. Secondary objective is to assess difference between the two approaches in terms of rate of intraoperative complication, postoperative morbidities (according with Clavien and Dindo Classification), hospital stay and at one year follow up. Inclusion criteria are: elective colectomy for complicated or non-complicated diverticular disease performed with laparoscopic or robotic approach and age between 18 and 90 years. Exclusion criteria are non-elective colectomy (emergency resection), open procedure, diverticular resection performed during other procedure (i.e. colectomy for cancer). Data will be collected in one year from the start of the study. Due to the lack of available evidence, it is impossible to draw definitive conclusions. With this study, the investigators hope to clarify the role of the robotic approach in the treatment of diverticular disease.

Official title: RObotic vs LAparoscopic Colectomy for DIverticulitis. A Multicenter Observational Prospective Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1450

Start Date

2023-06-01

Completion Date

2025-06-30

Last Updated

2025-01-29

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic Left colectomy

Patients are treated with a laparoscopic approach as the standard of care for the treatment of left-sided colonic diverticular disease, depending on the experience of the surgeon or institution.

PROCEDURE

Robotic left colectomy

Patients are treated with a robotic approach as the standard of care for the treatment of left-sided colonic diverticular disease, depending on the experience of the surgeon or institution.

Locations (1)

Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD

Grosseto, Tuscany, Italy