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)
1 other identifier
observational
10,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 9, 2023
May 1, 2023
1.7 years
January 21, 2022
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Eligibility Criteria
Patients undergoing colorectal and small intestine surgery.
You may qualify if:
- Colocolic, colorectal and small intestine anastomosis
- Neoplasia,
- Diverticulitis
- Mesenteric ischemia
- Iatrogenic or traumatic perforation
- Inflammatory bowel disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Med Anas Tahalead
- University of Baselcollaborator
- University of Hamburg-Eppendorfcollaborator
Study Sites (1)
University of Basel
Basel, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
January 21, 2022
First Posted
February 25, 2022
Study Start
May 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
May 9, 2023
Record last verified: 2023-05