Ileocolic Resection for Complex Crohn's Disease

Completed

• Conditions: Crohn Disease of Ileum
• Interventions: Procedure: ileocolic resection

• Registration Number: NCT03950726
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.

Detailed Description

From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Status Verified: 2019-05
• Study Completion: 2019-05-04
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• diagnosed Crohn's disease
• previous appendectomy trough a mcburney incision

Exclusion Criteria

• patients with major comorbidities
• age>75
• previous midline laparotomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	ileocolic resection	patients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection through the same incision
Control Group	ileocolic resection	patients with complex crohn's disease who had a previous open appendectomy through a mc burney incision scheduled for ileo-colic resection who underwent standard laparoscopic resection

Primary Outcome Measures

Name	Time	Method
Mean post-operative hospital stay	3-7 days	time from day of surgery to discharge
Mean operative time	75-156 minutes	duration of surgical procedure
Mean blood loss during surgical procedure	2 hours	blood loss from the beginning to the end of the procedure

Secondary Outcome Measures

Name	Time	Method
post-operative complications	30 days	complications according to Clavien Dindo classification