NCT03950726

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 7, 2019

Last Update Submit

May 14, 2019

Conditions

Crohn Disease of Ileum

Keywords

Crohn DiseaseIleocolic resectionAppendectomySingle-port incisionMcBurneyLaparoscopy

Outcome Measures

Primary Outcomes (3)

  • Mean operative time

    duration of surgical procedure

    75-156 minutes

  • Mean blood loss during surgical procedure

    blood loss from the beginning to the end of the procedure

    2 hours

  • Mean post-operative hospital stay

    time from day of surgery to discharge

    3-7 days

Secondary Outcomes (1)

  • post-operative complications

    30 days

Study Arms (2)

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

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

Interventions

ileocolic resectionPROCEDURE

Ileocolic resection through McBurney incision

Control GroupStudy Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 15, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

May 4, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05