HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Anesthesia
• Interventions: Procedure: usual care; Procedure: Hypnosis

• Registration Number: NCT03261414
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-25
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without preoperative hypnosis	usual care	standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
With preoperative hypnosis	Hypnosis	standard care plus hypnosis followed by administration of propofol for anesthesia induction

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	During the first 24 postoperative hours	Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record

Secondary Outcome Measures

Name	Time	Method
Intraoperative consumption of hypnotics and opioids	during first 7 postoperative days	The hypnotics and opioids drug dose will be recorded
Postoperative nausea and vomiting (PONV) Score	first 24 postoperative hours	PONV risk assessment tool Based on apfel's simplified risk score
Time physiological function recovery	during first 7 postoperative days	Ability to drink, to eat, to urinate, to walk
Total morphine consumption	between the 24 and the 48 postoperative hours	Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record
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	The antiemetic drug dose will be recorded

Trial Locations

Locations (1)

Hôpital Claude Huriez; 🇫🇷 Lille, France