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

Completed

• Conditions: Surgery; Crohn Disease

• Registration Number: NCT05161442
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-17
• Primary Completion: 2021-12-31
• Study Completion: 2023-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Crohn's disease
• Ileocolic resection

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospital readmission	30-day after surgery	30-day hospital readmission (yes/no)
conversion	30-day after surgery	intraoperative conversion to open (yes/no)
length of hospital stay	30-day after surgery	length of hospital stay (days)
postoperative complications	30-day after surgery	30-day postoperative complications described as binary variable (yes/no) and type.
postoperative complications grade	30-day after surgery	30-day postoperative complications graded according Clavien-Dindo classification (I-V).

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Quality of Life Index	7 years	quality of life measured according to Gastrointestinal Quality of Life Index (GIQLI)
Recurrence grade	5 years	Endoscopic recurrence (Rutgeerts)
Recurrence clinical	5 years	Clinical recurrence (yes/no)
Recurrence date	5 years	Endoscopic recurrence (date)