Diverticulitis Clinical Trial
— ROLADIOfficial title:
RObotic vs LAparoscopic Colectomy for DIverticulitis. A Multicenter Observational Prospective Study.
NCT number | NCT05829343 |
Other study ID # | ROLADI - 1.0 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2023 |
Est. completion date | June 30, 2025 |
Verified date | December 2023 |
Source | S.M. Misericordia Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 1450 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Elective or delayed urgency colorectal resection for left-sided DD - Fully minimally invasive (robotic or laparoscopic) procedures. Exclusion Criteria: - Age < 18 years - Urgent resection for DD - Hybrid minimally invasive resection - Conventional open resection. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of General and Emergency Surgery. Misericordia Hospital. Director: Coratti Andrea, MD | Grosseto | Tuscany |
Lead Sponsor | Collaborator |
---|---|
S.M. Misericordia Hospital |
Italy,
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-an — View Citation
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 A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | One year | |
Secondary | 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. | One year | |
Secondary | 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. | One year | |
Secondary | 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). | One year | |
Secondary | 30-day Post - operative re-operation | Evaluate the possible difference in term of rate of re-operation between the two groups within 30 day after surgery. | One year | |
Secondary | 30-day Post - operative mortality | Evaluate the possible difference in term of rate of mortality between the two groups within 30 day after surgery. | One year | |
Secondary | Length of hospital stay | Evaluate the possible difference in term of length of hospital stay (expressed in day) between the two groups. | One year | |
Secondary | Time to return at work | Evaluate the possible difference in time to return to work (expressed in days from surgery) between the two groups. | One year | |
Secondary | One year follow up | Evaluate the possible difference in terms of disease recurrence or incisional hernia, between the two groups at one year after surgery. | Two years |
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