Using indocyanine green to improve surgical outcomes in digestive surgeries
ICG Anastomotic Control in Digestive System Surgery
This study is testing if using a special dye called indocyanine green during digestive surgeries can help reduce complications like leaks in the surgical connections for patients having colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shandong Linglong Yingcheng Hospital Research network |
| Locations | 1 site (Yantai, Shandong) |
| Trial ID | NCT06270745 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of indocyanine green (ICG) on patients undergoing various digestive system surgeries, focusing on the occurrence of anastomotic leakage (AL). Conducted at Linglong Yingcheng Hospital in Shandong, China, it analyzes data from patients who had colorectal surgeries between January 2018 and December 2023. The study aims to identify risk factors associated with AL and assess postoperative morbidity within 30 days following surgery. Data will be collected from electronic medical records to evaluate surgical outcomes and complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 undergoing elective digestive system surgeries with primary anastomosis.
Not a fit: Patients with terminal colonic stomas, extensive resections, or those undergoing emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and reduced rates of anastomotic leakage in digestive surgeries.
How similar studies have performed: Other studies have shown promising results using indocyanine green for surgical applications, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * elective setting of surgery * digestive system surgery for benign or malignant 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
Where this trial is running
Yantai, Shandong
- Shandong Linglong Yingcheng Hospital — Yantai, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Xuan Qiu, MD — Shandong Linglong Yingcheng Hospital
- Study coordinator: Xuan Qiu, MD
- Email: qiuxuan100@163.com
- Phone: 8618354280081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.