Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04219956

Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

Led by Nantes University Hospital · Updated on 2025-11-14

278

Participants Needed

4

Research Sites

404 weeks

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

C

Centre de Recherche en Nutrition Humaine Ouest (CRNH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (over 18 years old)
  • Scheduled for a major abdominal surgery as a second procedure: eventration cure and restoration of digestive continuity
  • Planned use of a patient-controlled morphine pump or oral opioids after surgery
  • Ability to attend follow-up visits for up to 7 months (including 1 and 6 months post-surgery if needed)
  • Written informed consent provided
  • Affiliated with social security
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Minors, adults under guardianship, or those with legal protection
  • Undergoing oncological surgery
  • Surgery not considered painful (such as cholecystectomy, hernia, thyroidectomy, bariatric surgery)
  • Drug addiction or opioid dependency
  • Chronic pain lasting more than 3 months
  • Residents of nursing or convalescence homes
  • Planned hospitalization within 7 days before surgery
  • Severe undernutrition as defined by specific criteria
  • Refusal to change eating habits
  • Unable to eat by mouth before surgery
  • Unable to report or express pain
  • Severe psychiatric disorders
  • Unable to understand the protocol or provide informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

CHRU Brest La Cavale Blanche

Brest, France

Actively Recruiting

2

Hôpital Louis Mourier from Ap-HP

Colombes, France, 92700

Actively Recruiting

3

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

4

CHU Nantes Hôtel Dieu

Nantes, France

Actively Recruiting

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Research Team

C

Claire Blanchard, MD-PhD

CONTACT

L

Laetitia Berly

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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