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)

Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257863
• Other study ID #: P-Study
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Basel
• Contact: Anas Taha, MD
• Phone: 0041612075402
• Email: anas.taha[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Complication
• Anastomotic Leak
• Cancer
• Disease
• Diverticulitis
• Mental Disorders
• Morbus Crohn
• Postoperative Complications
• Problem Behavior
• Psychiatric Disorder
• Psychophysiologic Disorders
• Psychosomatic Disorder
• Somatoform Disorders

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Med Anas Taha	University of Basel, University of Hamburg-Eppendorf

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Length of Hospital Stay (in Days)	Impact of psychatric and psychosomatic disorders are having longer hospitalization	From surgery up to 12 weeks postoperatively
Primary	Intraoperative influid manangment	Impact of Intraoperative influid on the development of anastomotic insuffiency	Time Frame: From index surgery up to six weeks postoperatively
Primary	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