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Clinical trial

Indocyanine Green ICG in Segmentary Resection in Colo-rectal Surgery is Usefull to Decrease Leak Threshold: A Paralel Retrospetive Cohort Study

ID
Name
GREEN COLONIC SAFE ANASTOMOSIS
Description
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.
Trial arms
Trial start
2023-07-20
Estimated PCD
2023-12-01
Trial end
2024-02-01
Status
Completed
Treatment
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).
Arms:
Indocyanine Green
Other names:
Indocyanine Green
Size
115
Primary endpoint
Anastomotic leak at 30 days
30 days
Eligibility criteria
Inclusion criteria: * elective setting of surgery * segmentary left colon surgery including transverse resection, splenic flexure resection and left colectomy even for benign or malign pathology * 30 days of post-operative follow-up at least available from medical documentation * primary colo-colic or colo-rectal anastomosis with or without preventing ostomy * more than 18 years old, less than 90 years old Exclusion criteria: * terminal colonic stoma without anastomosis creation after demolitive step * extended transverse right hemicolectomy * left hemicolectomy with high vascular ligation * associated bowel or another splanchnic resection (i.e. neoplastic infiltration) * previous colic surgery * synchronous neoplasm * not reporting in operating form details about vascular ligation * lack in reporting in medical records of primary outcomes * stage IV cancer * ASA IV * less than 18 years old, more then 90 years old * emergency setting
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 115, 'type': 'ACTUAL'}}
Updated at
2024-03-18

1 organization

1 product

2 indications

Organization
Azienda Unità Sanitaria Locale di Piacenza
Product
ICG
Indication
Colon Surgery
Indication
Anastomotic leak