Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02083003
Recruitment Status : Terminated (End of commercialization of low polyamin diet)
First Posted : March 11, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Pain intensity for the 7 days [ Time Frame: 7 days ]
Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Pain scores measured on the day of surgery, [ Time Frame: 12 hours ]
    Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position)
  • frequency of impeded hospital discharge the day of surgery [ Time Frame: 24 hours ]
    Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)
  • Each day pain [ Time Frame: 7 days ]
    Pain scores (numerical scale from 0 to 10) assessed daily from J1 ( after surgery) to J7 in mid afternoon , lying at rest position , coughing and mobilization (from lying to sitting position) .
  • Quality of life [ Time Frame: 7 days ]
    QLQC30 Questionnaire (version 3)
  • Residual pain [ Time Frame: 30 days ]
    Pain score (numerical scale from 0 to 10)
  • Blood levels of polyamine [ Time Frame: 2 years ]
    Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Official Title  ICMJE Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Brief Summary It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Surgery
Intervention  ICMJE
  • Dietary Supplement: Polyamine low-diet
    Other Name: Poyldol plus (Nutrialys)
  • Dietary Supplement: Liberal alimentation
    Other Name: No specific alimentary recommendation
Study Arms  ICMJE
  • Experimental: Polyamine low-diet
    Polyamines depleted diet during the week before surgery : 2 cans per day of Polydol (oral alimentation without polyamines), associated to predefined menus low in polyamines
    Intervention: Dietary Supplement: Polyamine low-diet
  • Active Comparator: Liberal alimentation
    No specific alimentary diet
    Intervention: Dietary Supplement: Liberal alimentation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 14, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
100
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • laparoscopic cholecystectomy
  • ambulatory surgery
  • agreeing to follow a polyamine-low diet with Polydol plus

Exclusion Criteria:

  • Pregnancy
  • Contra-indication to a non-steroidal anti-inflammatory, to tramadol
  • Intolerance to cow proteins
  • Diabetic patients
  • Poor understanding of the French language.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083003
Other Study ID Numbers  ICMJE 2011/68
2011-A01675-36 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marc Fischler, MD Hopital Foch
PRS Account Hopital Foch
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP