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)

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05257863

Studienbeginn:
Mai 2022

Letztes Update:
09.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Diverticulitis, Postoperative Complications, Anastomotic Leak, Psychophysiologic Disorders, Mental Disorders, Problem Behavior, Somatoform Disorders

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Dr. Med Anas Taha

Collaborator:
University of Basel, University of Hamburg-Eppendorf,

Kontakt

Anas Taha, MD
Kontakt:
Phone: 0041612075402
E-Mail: anas.taha@unibas.ch» Kontaktdaten anzeigen

Stephanie Taha-Mehlitz, MD
Kontakt:
E-Mail: Stephanie.taha@clarunis.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University of Basel
Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Anas Taha, MD
Phone: 0041 61 207 54 02
E-Mail: anas.taha@unibas.ch» Ansprechpartner anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

2. 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

3. 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

4. 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

5. 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

Quelle: ClinicalTrials.gov

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"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)"

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