Anastomotic Leak, Colorectal Cancer, Crohn Disease, Diverticulosis, Mesenteric Ischemia, Ulcerative Colitis
Conditions
Keywords
Anastomotic Leak
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Cantonal Hospital of St. Gallen
University Hospital, Geneva
Clarunis - Universitäres Bauchzentrum Basel
University Hospital, Basel, Switzerland
University of Zurich
Michel Adamina, MD
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease
Exclusion criteria
* age \< 18 * recurrent colorectal cancer * peritoneal carcinomatosis or unresectable metastatic disease at time of bowel resection * informed consent not obtainable * follow-up \< 6 weeks after surgery * no reversal of and ostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Anastomotic leak | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Death | 90 days | — |
| Time to diagnosis of anastomotic leak | 90 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adjuvant/additive radiotherapy (yes/no) | 5 years | Did the patient receive adjuvant/additive radiotherapy after surgery? (yes/no) |
| Disease-free survival (months) | 5 years | — |
| Additive curative surgery (no/yes: liver; lung; locoragional relapse) | 5 years | Did the patient receive additive curative surgery after the initial intervention? (no/yes: liver; lung; locoragional relapse) |
| Overall survival (months) | 5 years | — |
| Adjuvant/additive immunochemotherapy (yes/no) | 5 years | Did the patient receive adjuvant/additive immunochemotherapy after surgery? (yes/no) |
Countries
Switzerland
Outcome results
None listed