Ileocolic Resection for Complex Crohn's Disease

May 14, 2019 updated by: simone sibio, University of Roma La Sapienza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient with complex terminal ileum Crohn's disease candidate for ileocolic resection who underwent to previous open appendectomy.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
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
Procedure: ileocolic resection
Ileocolic resection through McBurney incision
Control Group
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
Procedure: ileocolic resection
Ileocolic resection through McBurney incision

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative complications
Time Frame: 30 days
complications according to Clavien Dindo classification
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

May 4, 2019

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chirurgia Mini-invasiva PTV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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