Ileocolic Resection for Complex Crohn's Disease

Crohn Disease of Ileum Clinical Trial

Official title:

Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950726
• Other study ID #: Chirurgia Mini-invasiva PTV
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: May 4, 2019

Study information

• Verified date: May 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 4, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosed Crohn's disease

• previous appendectomy trough a mcburney incision

Exclusion Criteria:

• patients with major comorbidities

• age>75

• previous midline laparotomy

Related Conditions & MeSH terms

• Crohn Disease
• Crohn Disease of Ileum

Intervention

Procedure:
• ileocolic resection
Ileocolic resection through McBurney incision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean operative time	duration of surgical procedure	75-156 minutes
Primary	Mean blood loss during surgical procedure	blood loss from the beginning to the end of the procedure	2 hours
Primary	Mean post-operative hospital stay	time from day of surgery to discharge	3-7 days
Secondary	post-operative complications	complications according to Clavien Dindo classification	30 days