NCT05829343: ROLADI

RObotic Versus LAparoscopic Colectomy for DIverticulitis.

Recruiting now Last updated 29 January 2025

What this trial tests

trial testing Laparoscopic Left colectomy in Diverticular Diseases in 1,450 participants. Currently enrolling.

Timeline

1 June 2023

Primary endpoint
30 March 2025

30 June 2025

Quick facts

Lead sponsor	S.M. Misericordia Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,450
Start date	1 June 2023
Primary completion	30 March 2025
Estimated completion	30 June 2025
Sites	1 location across Italy

Drugs / interventions tested

• Laparoscopic Left colectomy
• Robotic left colectomy

Conditions studied

• Diverticular Diseases — all drugs for Diverticular Diseases →
• Diverticulitis — all drugs for Diverticulitis →

Sponsor

S.M. Misericordia Hospital

Who can join

18 and older, any sex, with Diverticular Diseases or Diverticulitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Analyzing the switch from laparoscopic to robotic surgery for diverticular disease: a comparative cohort study.
   Bhome R, Rajebhosale R, Smyth R, Martin E, et al · · 2025 · PMID 41428167 · DOI 10.1007/s11701-025-03061-2