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

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

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.

Study Overview

• Status: Suspended
• Conditions: Colorectal Cancer; Crohn Disease; Anastomotic Leak; Ulcerative Colitis; Diverticulosis; 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 Type: Observational
• Enrollment (Anticipated): 11000

Contacts and Locations

Study Locations

• Switzerland
  • Basel
    • Allschwil, Basel, Switzerland, 4123
      • Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland
  • Zürich
    • Winterthur, Zürich, Switzerland, 8401
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (months)		5 years
Overall survival (months)		5 years
Adjuvant/additive immunochemotherapy (yes/no)	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

Collaborators and Investigators

• Sponsor: Michel Adamina, MD
• Collaborators: University of Zurich; University Hospital, Geneva; University Hospital, Basel, Switzerland; Cantonal Hospital of St. Gallen; Clarunis - Universitäres Bauchzentrum Basel
• 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Anastomotic Leak
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Postoperative Complications; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Ischemia; Crohn Disease; Anastomotic Leak; Diverticulum; Diverticular Diseases; Mesenteric Ischemia
• Other Study ID Numbers: PANIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No