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NCT05161442 Clinical Trial

Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Surgery Clinical Trial

Official title:
Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05161442
Other study ID # 21-002141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date June 1, 2023

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.

Description:

All consecutive patients with Crohn's disease (CD) who underwent minimally invasive ileocolic resection from 2014 at Mayo Clinic were retrospectively identified using a prospectively maintained institutional database.

Recruitment information / eligibility
Status Completed
Enrollment 249
Est. completion date June 1, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Crohn's disease - Ileocolic resection Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary conversion intraoperative conversion to open (yes/no) 30-day after surgery
Primary postoperative complications 30-day postoperative complications described as binary variable (yes/no) and type. 30-day after surgery
Primary postoperative complications grade 30-day postoperative complications graded according Clavien-Dindo classification (I-V). 30-day after surgery
Primary length of hospital stay length of hospital stay (days) 30-day after surgery
Primary hospital readmission 30-day hospital readmission (yes/no) 30-day after surgery
Secondary Recurrence date Endoscopic recurrence (date) 5 years
Secondary Recurrence grade Endoscopic recurrence (Rutgeerts) 5 years
Secondary Recurrence clinical Clinical recurrence (yes/no) 5 years
Secondary Gastrointestinal Quality of Life Index quality of life measured according to Gastrointestinal Quality of Life Index (GIQLI) 7 years
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