ICG Anastomosis Control in Colon Surgery (NCT05981937) | Clinical Trial Compass
CompletedNot Applicable
ICG Anastomosis Control in Colon Surgery
Italy115 participantsStarted 2023-07-20
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.