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Completed

NCT Number: NCT03261414

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Anesthesia Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hypnosis

Procedure

A short preanesthetic hypnosis before induction of anesthesia

usual care

Procedure

Standard care before induction of anesthesia

Primary outcomes

  1. 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

  1. Total morphine consumption

    Time frame: 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

  2. Total number of patients with complications

    Time frame: during first 7 postoperative days

  3. Intraoperative consumption of hypnotics and opioids

    Time frame: during first 7 postoperative days

    The hypnotics and opioids drug dose will be recorded

  4. Antiemetics consumption

    Time frame: during first 7 postoperative days

    The antiemetic drug dose will be recorded

  5. Postoperative nausea and vomiting (PONV) Score

    Time frame: first 24 postoperative hours

    PONV risk assessment tool Based on apfel's simplified risk score

  6. Duration of hospital stay

    Time frame: during first 7 postoperative days

  7. Time physiological function recovery

    Time frame: during first 7 postoperative days

    Ability to drink, to eat, to urinate, to walk

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: HYSTERIA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2017
Registry last updated
Mar 9, 2021

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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