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Clinical Trials/NCT05257863
NCT05257863
Recruiting
Not Applicable

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)

Dr. Med Anas Taha1 site in 1 country10,000 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
Dr. Med Anas Taha
Enrollment
10000
Locations
1
Primary Endpoint
Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Med Anas Taha
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Med Anas Taha

Research Fellow

University of Basel

Eligibility Criteria

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

Outcomes

Primary Outcomes

Complication after surgery/ Comprehensive Complication Index/ Clavian Dindo Score

Time Frame: From index surgery up to six weeks postoperatively

Impact of psychatric and psychosomatic disorders are having higher complication rates

Intraoperative influid manangment

Time Frame: 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)

Time Frame: 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

Time Frame: From index surgery up to six weeks postoperatively

Check the risk for morbidity/mortality in colorectal surgery

Anastomotic insufficiency/leakage

Time Frame: From index surgery up to six weeks postoperatively

Predictive model with an app for the development of anastomosis insufficiency based on the risk factors.

Study Sites (1)

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