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ICG Anastomosis Control in Colon Surgery

NCT05981937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2024-03-18

No results posted yet for this study

Summary

This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital, Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection (transverse colic resection, left colectomy including sigmoidectomy, splenic colic flexure resection). Secondary aims are to detect and to investigate the impact of various risk factors on AL and morbidity and surgical performance within 30 days to surgery.

Conditions

  • Colon Surgery
  • Anastomotic Leak

Interventions

DRUG

ICG solution

ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and special scope and camera equipped with xenon light (CARL STORZ GmbH \& Co. KG, Tuttlingen, Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green® GmbH). ICG-ATT is routinely used whenever available in daily practice with the following protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available department and ICG anastomosis control is always performed if ICG device are available (no performed in case of not available ICG instrument for sterilization in case of two consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).

Sponsors & Collaborators

  • Azienda Unita Sanitaria Locale di Piacenza

    lead OTHER

Principal Investigators

  • Andrea Romboli, MD

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2023-12-01
Completion
2024-02-01
FDA Drug
Yes

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 NCT05981937 on ClinicalTrials.gov