NCT04219956

Brief Summary

The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Feb 2020Nov 2027

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

7.2 years

First QC Date

January 3, 2020

Last Update Submit

November 13, 2025

Conditions

Digestive System Surgical Procedures

Keywords

Abdominal surgeryPolyaminePostoperative painMorphineHypersensitivity

Outcome Measures

Primary Outcomes (1)

  • To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group

    To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room

    72 hours post-surgery

Secondary Outcomes (10)

  • Change in the analgesics consumption post-operatively

    15 days post-surgery

  • Change in the main dimension of pain

    6 months post-surgery

  • Change of the recovery time of the gas transit

    6 months post-surgery

  • Change of duration of urinary catheterization

    6 months post-surgery

  • Change in the delay before the first postoperative lift

    6 months post-surgery

  • +5 more secondary outcomes

Study Arms (2)

Polyamine deficient diet

EXPERIMENTAL

Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Other: Polyamine Deficient Diet

Control

NO INTERVENTION

Usual Diet plus two snacks

Interventions

Polyamine Deficient DietOTHER

Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Polyamine deficient diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 years)
  • Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
  • Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
  • Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
  • Written informed consent form obtained from the patient
  • Affiliated to the social security

You may not qualify if:

  • Pregnant women
  • Minor, adult under guardianship or benefiting from a legal protection
  • Oncological surgery
  • Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
  • Drug addicts patients, or under opiate dependency
  • Chronic pain patients (pain over 3 months)
  • Patients in nursing home or convalescence home (diet non possible in institution)
  • Planned hospitalisation before the intervention (during the 7 days before the surgery)
  • Patient refusing the possibility to change his eating habits
  • Oral feeding impossible preoperatively
  • Patient not able to express himself on their pain (silent, …)
  • Decompensated psychiatric pathologies (severe depression syndrome,…)
  • Patient unable to understand the protocol and/or to give his informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU Brest La Cavale Blanche

Brest, France

RECRUITING

Hôpital Louis Mourier from Ap-HP

Colombes, 92700, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CHU Nantes Hôtel Dieu

Nantes, France

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeHypersensitivity

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsImmune System Diseases

Study Officials

  • Claire Blanchard, MD-PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Blanchard, MD-PhD

CONTACT

+33 (0)2 40 08 30 22claire.blanchard@chu-nantes.fr

Laetitia Berly

CONTACT

+33 (0)2.53.52.62.04laetitia.berly@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The anesthetist is blinded to the arm of attribution
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

February 3, 2020

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations

FR(4)