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)

Recruiting

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

• Registration Number: NCT05257863
• Lead Sponsor: Dr. Med Anas Taha

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-02-25
• Study Start: 2022-05-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Basel; 🇨🇭 Basel, Switzerland