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

NCT05842135 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2025-02-10

No results posted yet for this study

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

Interventions

PROCEDURE

Laparoscopic approach to small bowel obstrcuction

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

Sponsors & Collaborators

  • San Salvatore Hospital, AST Pesaro-Urbino

    lead OTHER

Principal Investigators

  • DIEGO COLETTA, MD · San Salvatore Hospital, AST Pesaro-Urbino

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842135 on ClinicalTrials.gov