CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Dietother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03883464
NCT03883464N/ACompleted

Quality of Life Related to Digestive Symptoms After Cholecistectomy. Short Term Effects of a Low Fat Intake.

Consorci Sanitari de Terrassa·interventional·Posted Mar 21, 2019·Updated Mar 21, 2019

In Brief

A clinical study evaluating Diet for Dyspepsia and 2 related conditions. Completed, enrolled 160 participants across 1 site.

Detailed Summary

Background and aims: A low-fat diet has been traditionally recommended after cholecystectomy although evidence is lacking. The main aim of the study is to assess either if digestive symptoms improve following the operation and if the restriction of fat in diet does influence these symptoms. Methods: Symptoms have to be prospectively assessed by the GIQLI score (Gastrointestinal Quality of Life Index) at baseline, and one month after cholecystectomy. A low fat diet or equilibrated diet is randomly assigned to patientes distributed in two groups (N=80) candidates to gallbladder removal. Patients have to follow the prescribed diet and complet a questionnaire of symptoms (GIQLI Symptomantic score).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartFeb 20, 2017
Primary CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.3 years ago

Interventions

Dietother

Restriction in postoperative fat diet