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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04985981
• Other study ID #: PANIC
• Status: Suspended
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 11000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Colitis, Ulcerative
• Colorectal Cancer
• Crohn Disease
• Diverticulosis
• Diverticulum
• Ischemia
• Mesenteric Ischemia
• Ulcerative Colitis

Locations

Country	Name	City	State
Switzerland	Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland	Allschwil	Basel
Switzerland	Kantonsspital Winterthur	Winterthur	Zürich

Sponsors (6)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease-free survival (months)		5 years
Other	Overall survival (months)		5 years
Other	Adjuvant/additive immunochemotherapy (yes/no)	Did the patient receive adjuvant/additive immunochemotherapy after surgery? (yes/no)	5 years
Other	Adjuvant/additive radiotherapy (yes/no)	Did the patient receive adjuvant/additive radiotherapy after surgery? (yes/no)	5 years
Other	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
Primary	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	Occurrence of Death		90 days
Secondary	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