RObotic Versus LAparoscopic Colectomy for DIverticulitis.

Recruiting now

Conditions studied: Diverticular Diseases, Diverticulitis

In brief

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.

Key facts

Study ID

NCT05829343

Run by

S.M. Misericordia Hospital

People needed

1450

Starts

2023-06-01

Expected to finish

2025-06-30

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Elective or delayed urgency colorectal resection for left-sided DD
• Fully minimally invasive (robotic or laparoscopic) procedures.

You may not qualify if…

• Age < 18 years
• Urgent resection for DD
• Hybrid minimally invasive resection
• Conventional open resection.

Where it is running

• Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD — Grosseto, Tuscany, Italy (enrolling)

Full record on ClinicalTrials.gov

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