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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05257863
Other study ID # P-Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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