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Clinical Trials/NCT03261414
NCT03261414
Completed
Not Applicable

Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.

University Hospital, Lille1 site in 1 country77 target enrollmentMay 27, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
University Hospital, Lille
Enrollment
77
Locations
1
Primary Endpoint
Total morphine consumption
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease

Registry
clinicaltrials.gov
Start Date
May 27, 2015
End Date
January 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy
  • Never been operated for abdominal crohn's disease

Exclusion Criteria

  • Pregnant women
  • A history of intestinal resection for crohn's disease
  • Emergency surgery
  • Corticotherapy in progress
  • Deaf patients
  • non-Francophone Patients
  • Patients with knowledge of self-hypnosis

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: During the first 24 postoperative hours

Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record

Secondary Outcomes

  • Intraoperative consumption of hypnotics and opioids(during first 7 postoperative days)
  • Postoperative nausea and vomiting (PONV) Score(first 24 postoperative hours)
  • Time physiological function recovery(during first 7 postoperative days)
  • Total morphine consumption(between the 24 and the 48 postoperative hours)
  • Duration of hospital stay(during first 7 postoperative days)
  • Total number of patients with complications(during first 7 postoperative days)
  • Antiemetics consumption(during first 7 postoperative days)

Study Sites (1)

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