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Change in core study organization
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| Name | Class |
|---|---|
| Cantonal Hospital of St. Gallen | OTHER |
| University Hospital, Geneva | OTHER |
| Clarunis - Universitäres Bauchzentrum Basel | OTHER |
| University Hospital, Basel, Switzerland |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Death | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (months) | 5 years | |
| Overall survival (months) | 5 years | |
| Adjuvant/additive immunochemotherapy (yes/no) |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michel Adamina, Prof. Dr. med. | Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland | Study Chair |
| Anas Taha, Dr. med. | None currently | Principal Investigator |
| Thomas Steffen | Cantonal Hospital of St. Gallen | Principal Investigator |
| Stephanie Taha-Mehlitz, Dr. med. | Department of Visceral Surgery, Clarunis, University Hospital Basel, Basel, Switzerland | Principal Investigator |
| Frédéric Ris, Prof. Dr. med. | Department of Surgery, Hôpitaux Universitaires de Genève | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland | Allschwil | Basel | 4123 | Switzerland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 25, 2020 | Aug 14, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D015179 | Colorectal Neoplasms |
| D004240 | Diverticulum |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D065666 | Mesenteric Ischemia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
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| OTHER |
| University of Zurich | OTHER |
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| 90 days |
Did the patient receive adjuvant/additive immunochemotherapy after surgery? (yes/no) |
| 5 years |
| Adjuvant/additive radiotherapy (yes/no) | Did the patient receive adjuvant/additive radiotherapy after surgery? (yes/no) | 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) | 5 years |
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8401 | Switzerland |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D020763 | Pathological Conditions, Anatomical |
| D015212 | Inflammatory Bowel Diseases |
| D003092 | Colitis |
| D010532 | Peritoneal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |