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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06156033
Other study ID # 2023-01186
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date August 2024

Study information

Verified date December 2023
Source Centre Hospitalier Universitaire Vaudois
Contact Benoit Henry
Phone 0798828587
Email benoit.henry@chuv.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, single-center, observational study designed to to quantify complications following major visceral surgery major visceral surgery (such as pancreatic resection or colorectal colorectal surgery), and to identify digital biomarkers (collected pre, and post-operatively by a connected watch) enabling early early identification of patients with post-operative complications. Patients will be invited to wear a watch during the perioperative period, and will receive questionnaires about their their health status.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Patients will be recruited prospectively for a total of 50 patients. Inclusion criteria are : - Patients scheduled for elective major visceral surgery (pancreatic resection or colorectal surgery) under general anesthesia - 18 years of age or older Exclusion criteria will be : - Patient refusal and/or inability to understand and sign informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland CHUV Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comprehensive Complication Index The primary endpoint was the overall postoperative morbidity following major visceral surgery (such as pancreatic resection or colorectal surgery) as defined by the CCI (Comprehensive Complication Index), which calculates a patient's overall morbidity following surgery based on the Clavien-Dindo classification of complications. The Comprehensive Complication Index (CCI) reflects the severity of this overall burden of complications for the patient on a scale ranging from 0 (no complications) to 100 (death). J30 post-op
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