RObotic Versus LAparoscopic Colectomy for DIverticulitis.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorS.M. Misericordia Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Elective or delayed urgency colorectal resection for left-sided DD
Fully minimally invasive (robotic or laparoscopic) procedures.
Disqualifiers
Age < 18 years
Urgent resection for DD
Hybrid minimally invasive resection
Conventional open resection.
Trial population
Patients with diverticular disease of the left colon with surgical indication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic Left colectomy
Procedure/SurgeryPatients 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.
Robotic left colectomy
Procedure/SurgeryPatients 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.
Treatment groups
1,450 Participants
are divided into 2 treatment groupsGroup A: Robotic surgery group1 intervention
Group B: Laparoscopic surgery group1 intervention
Trial outcomes
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.
Time frame
One yearSecondary outcomes
1
Intra - operative complications
The first secondary outcome measure is to assess the difference between the two approaches in terms of intra-operative complications (e.g. bleeding, spleen injury, ureteral injury, bowel perforation)
Time frame
One year2
Operative time
Evaluate the possible difference in terms of operative time (expressed in minutes) between the two groups, to assess whether the robotic approach has a longer operative time than the laparoscopic approach.
Time frame
One year3
Complicated disease
Evaluate the difference between the two approaches in the number of complicated cases performed. For example, analyze whether one group performs more complicated diverticular disease (e.g., colonic stenosis, colorectal fistula, intraperitoneal abscess) than the other.
Time frame
One year4
30 day Post - operative complications
Another secondary outcome measure is to assess the difference between the two groups in terms of post-operative complications (using the Clavien and Dindo classification).
Time frame
One yearSponsors and contacts
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Source ClinicalTrials.gov