The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study

Sponsor

Michel Adamina, MD (Other)

Overall Status

Suspended

CT.gov ID

NCT04985981

Collaborator

Cantonal Hospital of St. Gallen (Other), University Hospital, Geneva (Other), Clarunis - Universitäres Bauchzentrum Basel (Other), University Hospital, Basel, Switzerland (Other), University of Zurich (Other)

11,000

Enrollment

Locations

Anticipated Duration (Months)

5500

Patients Per Site

262

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anastomotic Leak Colorectal Cancer Diverticulosis Crohn Disease Ulcerative Colitis Mesenteric Ischemia

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

11000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study: Development and External Validation of an International, Multicenter Machine Learning Algorithm for Prediction of Anastomotic Insufficiency After Colonic or Colorectal Anastomosis

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

Disease-free survival (months) [5 years]
Overall survival (months) [5 years]
Adjuvant/additive immunochemotherapy (yes/no) [5 years]
Did the patient receive adjuvant/additive immunochemotherapy after surgery? (yes/no)
Adjuvant/additive radiotherapy (yes/no) [5 years]
Did the patient receive adjuvant/additive radiotherapy after surgery? (yes/no)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland	Allschwil	Basel	Switzerland	4123
2	Kantonsspital Winterthur	Winterthur	Zürich	Switzerland	8401

Sponsors and Collaborators

Michel Adamina, MD
Cantonal Hospital of St. Gallen
University Hospital, Geneva
Clarunis - Universitäres Bauchzentrum Basel
University Hospital, Basel, Switzerland
University of Zurich

Investigators

Study Chair: Michel Adamina, Prof. Dr. med., Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland
Principal Investigator: 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