An observational study in Anastomotic Leak, Colorectal Cancer and Diverticulosis, sponsored by Michel Adamina, MD. Suspended at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Michel Adamina, MD · Observational
The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.
Anastomotic insufficiency leads to clinical strains for patients, and significantly increases morbidity and mortality. On average, hospital stay is extended by 12 days while healthcare-related expenses are increased by 30,000 USD when patients suffer from an anastomotic leak. In experienced centers, the approximated incidence of anastomotic insufficiency is 3,3% for colon and 8.6% for colorectal procedures. Multiple subgroups of patients with increased risk for anastomotic leaks have been described in previous publications. Meticulous preoperative recognition of patients with increased risk for anastomotic insufficiency is clinically beneficial, as it would permit improved ressource preparation, enhanced patient education and superior surgical decision-making. However, it is often difficult for clinicians to balance the plethora of crucial risk factors for anastomotic leaks for a single patient. Machine learning methods have been exceptionally effective at incorporating various clinical variables into one unified risk prediction model. To the authors' best knowledge, there does not yet exist a credible prediction model or a conclusive prediction score for anastomotic insufficiency after colon and colorectal anastomosis. The aim of the Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study is to establish and externally validate an efficient machine-learning-based prediction tool based on multicenter data from a range of international centers.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 11,000 is above the median of 166 across 111 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →This is the only study on the registry with Michel Adamina, MD as lead sponsor.
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Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease. Only patients who have reached the age of 18 will be accepted. Only patients who are able to give informed consent to the procedure will be accepted.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Occurrence of Anastomotic leak
Occurrence of anastomotic insufficiency/leak is defined as any clinical signs of leakage, confirmed by radiological examination, endoscopy, clinical examination of the anastomosis, or upon reoperation.
Time frame: 5 years
Occurrence of Death
Time frame: 90 days
Time to diagnosis of anastomotic leak
Time to diagnosis of a leakage will be calculated as days between the index operation and diagnosis of the leakage by imaging with extraluminal contrast, endoscopy, re-operation, or when fecal containing fluid is objectified in a drainage.
Time frame: 90 days
Disease-free survival (months)
Time frame: 5 years
Overall survival (months)
Time frame: 5 years
Adjuvant/additive immunochemotherapy (yes/no)
Did the patient receive adjuvant/additive immunochemotherapy after surgery? (yes/no)
Time frame: 5 years
Adjuvant/additive radiotherapy (yes/no)
Did the patient receive adjuvant/additive radiotherapy after surgery? (yes/no)
Time frame: 5 years
Additive curative surgery (no/yes: liver; lung; locoragional relapse)
Did the patient receive additive curative surgery after the initial intervention? (no/yes: liver; lung; locoragional relapse)
Time frame: 5 years
Plan to share: Undecided
Started Apr 2021 (actual). Primary completion is estimated for Dec 2022, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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