Actively Recruiting

Age: 18Years +
All Genders
ID05829343

Robotic versus Laparoscopic Colectomy for Diverticulitis A Multicenter Observational Prospective Study

Led by S.M. Misericordia Hospital · Updated on 2025-01-29

1450

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of robotic versus laparoscopic surgery for treating diverticular disease, a condition affecting the colon. This prospective multicenter study aims to determine if robotic colectomy reduces the need to switch to open surgery compared to laparoscopic surgery. The study also examines differences in complications during and after surgery, hospital stay length, and patient outcomes up to one year after treatment. The study includes two groups of patients undergoing elective or delayed urgent minimally invasive surgery for left-sided diverticular disease. One group receives robotic left colectomy, and the other undergoes laparoscopic left colectomy, both considered standard care depending on surgeon or institutional experience. Data collection spans one year with follow-up extending to two years to monitor surgical outcomes and recovery. Participants will provide information on their health and surgical experiences through a secure database accessible via mobile devices. Researchers will track demographics, surgical details, complications within 30 days after surgery, time to return to work, and one-year post-surgery outcomes. The primary outcome is the rate of conversion to open surgery within one year, with secondary measures including operative time, complications, hospital stay duration, and overall recovery. The study follows ethical standards and plans to share findings through scientific publications and presentations.

CONDITIONS

Brief Title

RObotic Versus LAparoscopic Colectomy for DIverticulitis.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Elective or delayed urgency colorectal resection for left-sided diverticular disease
  • Fully minimally invasive procedures using robotic or laparoscopic approach
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Urgent resection for diverticular disease
  • Hybrid minimally invasive resection
  • Conventional open resection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration following surgery

Participants undergo either robotic or laparoscopic left colectomy as elective or delayed urgent surgical treatment for left-sided diverticular disease. Intraoperative and immediate postoperative outcomes are collected during this period.

1 surgical hospitalization visit

Post-operative Follow-up

Duration - 30 days

Participants are monitored for postoperative complications, reoperations, mortality, length of hospital stay, and time to return to work up to 30 days after surgery.

Approximately 2 to 3 visits within 30 days post-surgery

Long-term Monitoring

Duration - 1 year

Participants are followed up for one year to assess conversion rates, intraoperative complications, operative time, complicated disease status, and long-term outcomes after surgery.

Periodic follow-up visits up to 1 year

Trial Site Locations

Total: 1 location

1

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

Grosseto, Tuscany, Italy, 58100

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Robotic versus conventional laparoscopic technique for the treatment of left-sided colonic diverticular disease: a systematic review with meta-analysis.

Giuseppe Giuliani, Francesco Guerra, Diego Coletta...

https://pubmed.ncbi.nlm.nih.gov/34599362