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

NCT04985981 | Suspended DMC

• 1 other identifier: PANIC
• Study Type: observational
• Target: 11,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Anastomotic Leak; Colorectal Cancer; Diverticulosis; Crohn Disease; Ulcerative Colitis; Mesenteric Ischemia

Keywords

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Occurrence of Death

  90 days

• Time to diagnosis of anastomotic leak

  90 days

Other Outcomes (5)

• Disease-free survival (months)

  5 years

• Overall survival (months)

  5 years

• Adjuvant/additive immunochemotherapy (yes/no)

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who underwent colon or colorectal anastomosis for neoplasia, diverticulitis, mesenterial ischemia, iatrogenic or traumatic perforation, or inflammatory bowel disease

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Clinical Research and Artificial Intelligence in Surgery, Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland

Allschwil, Basel, 4123, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms; Diverticulum; Crohn Disease; Colitis, Ulcerative; Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticular Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Colitis; Peritoneal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chefarzt

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

CH (2)