RObotic Versus LAparoscopic Colectomy for DIverticulitis.

NCT05829343 | Recruiting DMC

• 1 other identifier: ROLADI - 1.0
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diverticular Diseases; Diverticulitis

Keywords

Diverticular Disease; Robotic surgery; Laparoscopic surgery; Minimal invasive surgery; Colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Conversion rate

  The primary objective is to evaluate whether the robotic approach reduces the rate of conversion to open surgery compared to laparoscopic surgery.

  One year

Secondary Outcomes (9)

• Intra - operative complications

  One year

• Operative time

  One year

• Complicated disease

  One year

• 30 day Post - operative complications

  One year

• 30-day Post - operative re-operation

  One year

Study Arms (2)

Robotic surgery group

Patients with diverticular disease resected with a robotic approach.

Procedure: Robotic left colectomy

Laparoscopic surgery group

Patients with diverticular disease resected with a laparoscopic approach.

Procedure: Laparoscopic Left colectomy

Interventions

Laparoscopic Left colectomy PROCEDURE

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.

Laparoscopic surgery group

Robotic left colectomy PROCEDURE

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.

Robotic surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diverticular disease of the left colon with surgical indication.

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.

Sponsors & Collaborators

• S.M. Misericordia Hospital: lead

Study Sites (1)

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

Grosseto, Tuscany, 58100, Italy

RECRUITING

Related Publications (2)

• Giuliani G, Guerra F, Coletta D, Giuliani A, Salvischiani L, Tribuzi A, Caravaglios G, Genovese A, Coratti A. Robotic versus conventional laparoscopic technique for the treatment of left-sided colonic diverticular disease: a systematic review with meta-analysis. Int J Colorectal Dis. 2022 Jan;37(1):101-109. doi: 10.1007/s00384-021-04038-x. Epub 2021 Oct 1.

  PMID: 34599362 BACKGROUND

• Larkins K, Mohan H, Apte SS, Chen V, Rajkomar A, Larach JT, Smart P, Heriot A, Warrier S. A systematic review and meta-analysis of robotic resections for diverticular disease. Colorectal Dis. 2022 Oct;24(10):1105-1116. doi: 10.1111/codi.16227. Epub 2022 Aug 9.

  PMID: 35723895 BACKGROUND

MeSH Terms

Conditions

Diverticular Diseases; Diverticulitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Assistant surgeon

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 25, 2023
• Study Start: June 1, 2023
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)