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Completed

NCT Number: NCT03950726

Ileocolic Resection for Complex Crohn's Disease

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.

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Key information

Conditions

Crohn Disease of Ileum Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ileocolic resection

Procedure

Ileocolic resection through McBurney incision

Primary outcomes

  1. Mean operative time

    Time frame: 75-156 minutes

    duration of surgical procedure

  2. Mean blood loss during surgical procedure

    Time frame: 2 hours

    blood loss from the beginning to the end of the procedure

  3. Mean post-operative hospital stay

    Time frame: 3-7 days

    time from day of surgery to discharge

Secondary outcomes

  1. post-operative complications

    Time frame: 30 days

    complications according to Clavien Dindo classification

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
May 15, 2019
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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