Ileocolic Resection for Complex Crohn's Disease

NCT ID: NCT03950726

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-05-04

Brief Summary

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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

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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.

Conditions

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Crohn Disease of Ileum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ileocolic resection

Intervention Type PROCEDURE

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

ileocolic resection

Intervention Type PROCEDURE

Ileocolic resection through McBurney incision

Interventions

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ileocolic resection

Ileocolic resection through McBurney incision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients with major comorbidities
* age\>75
* previous midline laparotomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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simone sibio

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Chirurgia Mini-invasiva PTV

Identifier Type: -

Identifier Source: org_study_id

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