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

March 19, 2019 updated by: Lluis Oms Bernad, Consorci Sanitari de Terrassa

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction The post-cholecystectomy syndrome includes a heterogeneous group of gastrointestinal symptoms presenting after cholecystectomy. However, the term is inaccurate as it is frequently used both for biliary and non-biliary disorders. Liver function and imaging tests are key to rule out biliary disorders such as choledocolithiasis, bile duct injuries or biliary leaks that may have a specific treatment.

Symptoms of non-biliary disorders may persist or arise the novo after surgery. Patients may refer a large variation of symptoms including upper abdominal pain, dyspepsia, diarrhoea, constipation, bloating, flatulence, heartburn or nausea. However, data on prevalence vary enormously. A recent systematic review underscored the lack of accurate data regarding post-cholecystectomy symptoms and only one of the 38 included studies fulfilled all quality criteria. This review showed a great variation of symptoms among the studies, diarrhoea being the most reported postoperative symptom but also with the largest variation across the studies. Moreover, the review found differences between persistent and de novo symptoms in the studies in which this distinction was made, showing that some symptoms considered to be due to the cholecystectomy may, however, be explained by coexisting pathologies such as irritable bowel syndrome or gastrointestinal disorders.

It has also been reported that most preoperative symptoms decrease after surgery except for diarrhoea, which may be a more persistent problem for a proportion of patients. However, data are controversial. Although some studies have reported a frequency of post-cholecystectomy diarrhoea between 5-12%, others support that new onset of diarrhoea is infrequent. A recent large population-based cohort study showed that cholecystectomy was associated with an increased risk of diarrhoea and stomach pain postoperatively, but a weakness of the study may be that questionnaires on gastrointestinal symptoms had not been validated.

Furthermore, a low-fat diet has been traditionally recommended after cholecystectomy for a variable period of time, but there is not a standard guideline on nutrition after surgery . Supposedly, the rationale for this recommendation is that the digestion of lipids may be hindered without the gallbladder. Other recommendations include a gradually increase of the fibre intake. However, literature addressing this issue is scarce and, to our knowledge, only three studies have assessed the effect of a low-fat diet on postoperative symptoms after cholecystectomy. One study failed to find differences in the postoperative symptoms between patients who followed a low-fat diet compared with a normal diet. On the contrary, two studies reported more postoperative symptoms in patients who did not follow a low-fat diet. The current situation is that there is a great variability in the dietary advice given by surgeons after surgery and, in addition, patients may or may not follow their recommendations making it more difficult to know whether specific dietary advice would be really necessary. A previous descriptive study carried by our group has evidenced the expected postoperative improvement in QoL and symtoms following the operation and has shown no differences in GIQLI scores between patients restricting fat intake and those following a diet without restriction.

Therefore, our aims is to prospectively assess symptoms after cholecystectomy by using a validated questionnaire and to assess the potential effect of the type of diet (fat restriction or banaced) followed after cholecystectomy.

Study design Prospective randomized trial in patients admitted at Consorci Sanitari de Terrassa (Barcelona, Spain) for treatment of symptomatic gallstone disease or its complications, evaluating short term postoperative digestive symptoms and if they are influenced by diet. Randomization according a random number table.

Group A: Low fat diet for hyperlipidemic conditions provided by Dietetics team. Group B: Balanced diet provided by Dietetics team

Participants Inclusion criteria: age > 18 years; symptomatic gallstone disease considering biliary pain or complications of gallstones (pancreatitis, cholangitis, cholecystitis).

Exclusion criteria: not willing to participate in the study, inability to understand the information due to mental disorders or language barrier; and severe postoperative complications which could affect the assessment of quality of life after cholecystectomy.

Assessments Prospective collection of patiens demographics, comorbidities and type of surgery. Score of digestive symptoms at baseline, and one month after the surgical procedure. Evaluations carried out during the visit at clinics at baseline and one month after surgery.

Completion the validated version of GIQLI score in Spanish, which has been widely used to assess the quality of life related to several digestive disorders including gallstone disease. The GIGLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life and score from 0 to 4. Higher scores represent a better quality of life and the maximum score is 144. The GIGLI has five subscales: symptoms, physical function, emotional function, social function, and effects of treatment.

The symptoms subscale is the one considered in this study including:

Pain, Bloating, Epigastric fullness, Flatus, Belching, Abdominal noises, Bowel frequency, Restricted eating, Enjoyed eating, Regurgitation, Dysphagia, Eating speed, Nausea, Diarrhoea, Bowel urgency, Constipation, Blood in stod, Burning, Fecal incontinence.

Statistical analysis Descriptions of data will be presented as means and standard deviation for quantitative measures, and as absolute and relative frequencies for qualitative measures. Student's paired t test will be applied to assess differences in the GIGLI score between baseline and one month after treatment. Independent t-test will be applied to assess differences in the GIQLI overtime depending on the type of diet. A p-value <0.05 will be considered statistically significant. Sample size has been evaluated on the basis of standard deviation of the GIQLI score in our precedent descriptive study. Eighty patients per group for a beta error of 20% have to be included. Data analysis will be performed using the statistical Package SPSS version 20.

Ethical approval The study was approved by the Ethics Committees of the Consorci Sanitari de Terrassa. All patients provided written informed consent.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Gallbladder removal because biliary pain or gallstones complications

Exclusion Criteria:

- Major postoperative complications, refusal to participate or not completion of questionnary.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low fat intake
Patients who underwent cholecystectomy and were instructed to have a low fat diet.
Other: Diet
Restriction in postoperative fat diet
No Intervention: Regular diet
Patients who underwent cholecystectomy and were instructed to have a regular diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Quality of Life (GIQLI)Symptoms
Time Frame: 1 month

The Gastrointestinal Quality of Life Index (GIQLI) is a score validated in Spanish, that has been widely used to assess the quality of life related to several digestive disorders including gallstone disease. The GIGLI is a 36-item patient reported outcomes instrument designed to assess gastrointestinal quality of life. Items score from 0 to 4. Higher scores represent a better quality of life and the overall score ranges from 0 to 144, being a score 100 or higher indicative a good health status. This score has five subscales: symptoms, physical function, emotional function, social function, and effects of treatment.

The symptoms subscale is the one considered and includes: Pain, Bloating, Epigastric fullness, Flatus, Belching, Abdominal noises, Bowel frequency, Restricted eating, Enjoyed eating, Regurgitation, Dysphagia, Eating speed, Nausea, Diarrhoea, Bowel urgency, Constipation, Blood in stod, Burning, Fecal incontinence. It scores from 0 to 76.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Luis Oms, PhD, Consorci Sanitari de Terrassa
  • Study Director: Luis Oms, PhD, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Actual)

March 12, 2019

Study Completion (Actual)

March 12, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-16-102-028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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