RecruitingNCT05829343

RObotic Versus LAparoscopic Colectomy for DIverticulitis.

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


Sponsor

S.M. Misericordia Hospital

Enrollment

1,450 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURELaparoscopic 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.

PROCEDURERobotic 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05829343


Related Trials