ICG Anastomotic Control in Digestive System Surgery
1 other identifier
observational
200
1 country
1
Brief Summary
This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 23, 2024
February 1, 2024
6.1 years
February 14, 2024
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leak at 30 days
Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III
30 days
Secondary Outcomes (1)
Post-operative morbidity
30 days
Study Arms (2)
Indocyanine Green
Indocyanine green infusion during digestive system surgery
non-Indocyanine Green
No indocyanine green infusion during digestive system surgery
Interventions
Whether to use ICG to assess anastomotic perfusion during digestive system surgery
Eligibility Criteria
A consecutive series of patients underwent digestive system surgery at our institution between January 1, 2018, and July 31, 2023
You may qualify if:
- elective setting of surgery
- digestive system surgery for benign or malignant pathology
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Linglong Yingcheng Hospital
Yantai, Shandong, 264000, China
Related Publications (1)
Qiu X, Kashchenko VA, Zavrazhnov AA, Lankov TS, Ye L, Strizheletsky VV, Smirnov GA. Deep impact analysis of surgical strategy changes guided by indocyanine green fluorescence angiography in laparoscopic low anterior resection for rectal cancer. Int J Colorectal Dis. 2026 Jan 3;41(1):7. doi: 10.1007/s00384-025-05065-8.
PMID: 41483178DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuan Qiu, MD
Shandong Linglong Yingcheng Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2024
First Posted
February 21, 2024
Study Start
January 1, 2018
Primary Completion
February 1, 2024
Study Completion
June 1, 2024
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share