Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)

Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery.

Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques

The service mentioned above will be publicly available as a web-based application

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Cancer; Anastomotic Leak; Diverticulitis; Psychiatric Disorder; Anastomotic Complication; Psychosomatic Disorder; Morbus Crohn; Colitis Ulcerosa; Small Intestine Anastomotic Leak

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Stephanie Taha-Mehlitz, MD; Email: Stephanie.taha@clarunis.ch
• Study Contact Backup: Name: Anas Taha, MD; Phone Number: 0041612075402; Email: anas.taha@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University of Basel
    • Principal Investigator: Stephanie Taha-Mehlitz, MD
    • Contact: Anas Taha, MD; Phone Number: 0041 61 207 54 02; Email: anas.taha@unibas.ch

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing colorectal and small intestine surgery.

Description

Inclusion Criteria:

• Colocolic, colorectal and small intestine anastomosis
• Neoplasia,
• Diverticulitis
• Mesenteric ischemia
• Iatrogenic or traumatic perforation
• Inflammatory bowel disease

Exclusion Criteria:

• Patients <18 years
• Patients suffering from recurrent colorectal cancer bearing
• Peritoneal carcinomatosis or unresectable metastatic disease at the time of bowel resection and anastomosis will be excluded.
• Patients who cannot be followed up on for more than six weeks after surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic insufficiency/leakage	Predictive model with an app for the development of anastomosis insufficiency based on the risk factors.	From index surgery up to six weeks postoperatively
Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score	Impact of psychatric and psychosomatic disorders are having higher complication rates	From index surgery up to six weeks postoperatively
Length of Hospital Stay (in Days)	Impact of psychatric and psychosomatic disorders are having longer hospitalization	From surgery up to 12 weeks postoperatively
Intraoperative influid manangment	Impact of Intraoperative influid on the development of anastomotic insuffiency	Time Frame: From index surgery up to six weeks postoperatively
Development of a preoperative score for morbidity/mortality in colorectal surgery	Check the risk for morbidity/mortality in colorectal surgery	From index surgery up to six weeks postoperatively

Collaborators and Investigators

• Sponsor: Dr. Med Anas Taha
• Collaborators: University of Basel; University of Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: machine learning; artificial intelligence; clinical prediction modeling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Digestive System Diseases; Pathologic Processes; Neurologic Manifestations; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Disease; Problem Behavior; Mental Disorders; Somatoform Disorders; Anastomotic Leak; Postoperative Complications; Diverticulitis; Psychophysiologic Disorders
• Other Study ID Numbers: P-Study

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