RObotic Vs LAparoscopic Colectomy for DIverticulitis. a Multicenter Observational Prospective Study.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• Elective or delayed urgency colorectal resection for left-sided DD

• Fully minimally invasive (robotic or laparoscopic) procedures.

Locations
Other Locations
Italy
Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD
RECRUITING
Grosseto
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 1450
Treatments
Robotic surgery group
Patients with diverticular disease resected with a robotic approach.
Laparoscopic surgery group
Patients with diverticular disease resected with a laparoscopic approach.
Sponsors
Leads: S.M. Misericordia Hospital

This content was sourced from clinicaltrials.gov