REsectability Small Bowel Obstruction LAParoscopic (RESBOLAP) Score. Multicentric Data Registry

NCT05842135 | Completed DMC

• 1 other identifier: CERP22078
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

AIM OF THE STUDY The aim of the study is to develop a Resectability Laparoscopic Score as a helpful instrument during intraoperative decision-making in the setting of emergency laparoscopic surgery for small bowel obstruction (SBO) by analyzing a multicenter data registry. DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green (ICG) fluorescence angiography (FA) for doubts about bowel viability after the resolution of the obstructive mechanism; the second phase of retrospective analysis to develop the Resectability Score. METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism, with consequent intraoperative enrolment in the study Registry. The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality. It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3, representing the study's primary object. All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure. Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously. The presence and pattern of arterial supply is tested and compared with that of healthy bowel. Proper clearance of the dye was also appraised to verify adequate venous drainage. Following the reversal of the underlying cause of the ischaemic injury, and after generous irrigation with warm saline, the involved bowel segment was further evaluated with FA after 10 min, regardless of the return of visible peristalsis. Routine postoperative clinical judgment will be considered sufficient to check bowel vitality. The need for a second-look surgery and delayed resections will be recorded. All centers could participate with a maximum of 3-4 members (co-authorship) Data will be recorded by a simple and brief online Case Report Form (CRF) on which upload also a photo/brief video of the FA, will be filled out by every participating center for each patient. A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study.

Conditions

Small Bowel Obstruction

Keywords

indocyanine green fluorescence; small bowel obstruction; fluorescent angiography; resectability score; laparoscopic emergency surgery

Outcome Measures

Primary Outcomes (1)

• Development of a resectability laparoscopic score based on data of a multicentric data registry

  Based on these items a resectability laparoscopic score is developed: * Length of compromised bowel expressed in centimeters * Quality of peritoneal fluid * Time to presence of peristalsis after resolution of the obstruction expressed in minutes * Time of return to healty bowel coloration after resolution of the obstruction expressed in minutes * ICG-fluorescence angiographic patterns * Bowel resection rate expressed as event/non event * Reintervention rate expressed as event/non event * Date of reintervention expressed in days * Delayed bowel resection rate expressed as event/non event

  Event occurred at the time of surgery or after the first surgical interventional without bowel resection

Secondary Outcomes (1)

• Development of a multicentric data registry of patients underwent laparoscopic approach to small bowel obstruction and ICG fluorescent angiography

  12 months eventually extended by further 6 months

Interventions

Laparoscopic approach to small bowel obstrcuction PROCEDURE

Bowel viability assessment by indocyanine green fluorescent angiography during laparoscopic approach to small bowel obstruction

Also known as: indocyanine green fluorescent angiograhy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients more undergoing emergency laparoscopic surgery for SBO with intraoperative doubts about bowel viability after the resolution of the occlusive mechanism

You may qualify if:

• All centers that routinely perform emergency laparoscopic surgery for SBO and have imaging systems with technology for the detection of near-infrared/indocyanine green fluorescence
• All patients more than 18 years old undergoing emergency laparoscopic surgery for SBO with intraoperative doubts about bowel viability after the resolution of the occlusive mechanism

You may not qualify if:

• Open surgical procedure for SBO

Sponsors & Collaborators

• San Salvatore Hospital, AST Pesaro-Urbino: lead

Study Sites (1)

Department of General Surgery, San Salvatore Hospital , AST Pesaro-Urbino

Pesaro, Pesaro-Urbino, 61121, Italy

Location

Study Officials

• DIEGO COLETTA, MD

  San Salvatore Hospital, AST Pesaro-Urbino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: OTHER
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: December 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)