Back to resultsPolyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Primary Purpose
Surgery
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Polyamine low-diet
Liberal alimentation
Sponsored by
About this trial
This is an interventional prevention trial for Surgery focused on measuring Pain, Polyamine, Cholecystectomy
Eligibility Criteria
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.
Sites / Locations
- Hôpital de la Croix Saint-Simon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Polyamine low-diet
Liberal alimentation
Arm Description
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
No specific alimentary diet
Outcomes
Primary Outcome Measures
Pain intensity for the 7 days
Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients
Secondary Outcome Measures
Pain scores measured on the day of surgery,
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
Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)
Each day pain
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
QLQC30 Questionnaire (version 3)
Residual pain
Pain score (numerical scale from 0 to 10)
Blood levels of polyamine
Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02083003
Brief Title
Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Official Title
Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
End of commercialization of low polyamin diet
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
Pain, Polyamine, Cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyamine low-diet
Arm Type
Experimental
Arm Description
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
Arm Title
Liberal alimentation
Arm Type
Active Comparator
Arm Description
No specific alimentary diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyamine low-diet
Other Intervention Name(s)
Poyldol plus (Nutrialys)
Intervention Type
Dietary Supplement
Intervention Name(s)
Liberal alimentation
Other Intervention Name(s)
No specific alimentary recommendation
Primary Outcome Measure Information:
Title
Pain intensity for the 7 days
Description
Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pain scores measured on the day of surgery,
Description
Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position)
Time Frame
12 hours
Title
frequency of impeded hospital discharge the day of surgery
Description
Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)
Time Frame
24 hours
Title
Each day pain
Description
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) .
Time Frame
7 days
Title
Quality of life
Description
QLQC30 Questionnaire (version 3)
Time Frame
7 days
Title
Residual pain
Description
Pain score (numerical scale from 0 to 10)
Time Frame
30 days
Title
Blood levels of polyamine
Description
Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler, MD
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital de la Croix Saint-Simon
City
Paris
State/Province
Hauts de Seine
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
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Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
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