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

NCT03883464 | Completed DMC

• 1 other identifier: 02-16-102-028
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dyspepsia; Postoperative Complications; Quality of Life

Keywords

Quality of live; Cholecystectomy; Low fat diet; Postoperative

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Quality of Life (GIQLI)Symptoms

  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

Study Arms (2)

Low fat intake

EXPERIMENTAL

Patients who underwent cholecystectomy and were instructed to have a low fat diet.

Other: Diet

Regular diet

NO INTERVENTION

Patients who underwent cholecystectomy and were instructed to have a regular diet.

Interventions

Diet OTHER

Restriction in postoperative fat diet

Low fat intake

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Gallbladder removal because biliary pain or gallstones complications

You may not qualify if:

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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (23)

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  PMID: 11211857 BACKGROUND

• Altomare DF, Rotelli MT, Palasciano N. Diet After Cholecystectomy. Curr Med Chem. 2019;26(19):3662-3665. doi: 10.2174/0929867324666170518100053.

  PMID: 28521679 BACKGROUND

• Marcason W. What medical nutrition therapy guideline is recommended post-cholecystectomy? J Acad Nutr Diet. 2014 Jul;114(7):1136. doi: 10.1016/j.jand.2014.05.009. No abstract available.

  PMID: 24956996 BACKGROUND

• Shin Y, Choi D, Lee KG, Choi HS, Park Y. Association between dietary intake and postlaparoscopic cholecystectomic symptoms in patients with gallbladder disease. Korean J Intern Med. 2018 Jul;33(4):829-836. doi: 10.3904/kjim.2016.223. Epub 2017 Nov 10.

  PMID: 29117670 BACKGROUND

• Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

  PMID: 7749697 BACKGROUND

• Quintana JM, Cabriada J, Lopez de Tejada I, Varona M, Oribe V, Barrios B, Perdigo L, Bilbao A. Translation and validation of the gastrointestinal Quality of Life Index (GIQLI). Rev Esp Enferm Dig. 2001 Nov;93(11):693-706. English, Spanish.

  PMID: 11995369 BACKGROUND

• Phillips SF. Diarrhea after cholecystectomy: if so, why? Gastroenterology. 1996 Sep;111(3):816-8. doi: 10.1053/gast.1996.v111.agast961110816. No abstract available.

  PMID: 8780589 BACKGROUND

• Tan VP. The low-FODMAP diet in the management of functional dyspepsia in East and Southeast Asia. J Gastroenterol Hepatol. 2017 Mar;32 Suppl 1:46-52. doi: 10.1111/jgh.13697.

  PMID: 28244670 BACKGROUND

• Khodarahmi M, Azadbakht L. Dietary fat intake and functional dyspepsia. Adv Biomed Res. 2016 Apr 21;5:76. doi: 10.4103/2277-9175.180988. eCollection 2016.

  PMID: 27195249 BACKGROUND

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  PMID: 19857610 RESULT

• Filip M, Saftoiu A, Popescu C, Gheonea DI, Iordache S, Sandulescu L, Ciurea T. Postcholecystectomy syndrome - an algorithmic approach. J Gastrointestin Liver Dis. 2009 Mar;18(1):67-71.

  PMID: 19337637 RESULT

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  PMID: 15529838 RESULT

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  PMID: 23052498 RESULT

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  PMID: 8780565 RESULT

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  PMID: 3428678 RESULT

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  PMID: 8495304 RESULT

• Sauter GH, Moussavian AC, Meyer G, Steitz HO, Parhofer KG, Jungst D. Bowel habits and bile acid malabsorption in the months after cholecystectomy. Am J Gastroenterol. 2002 Jul;97(7):1732-5. doi: 10.1111/j.1572-0241.2002.05779.x.

  PMID: 12135027 RESULT

• Luman W, Adams WH, Nixon SN, Mcintyre IM, Hamer-Hodges D, Wilson G, Palmer KR. Incidence of persistent symptoms after laparoscopic cholecystectomy: a prospective study. Gut. 1996 Dec;39(6):863-6. doi: 10.1136/gut.39.6.863.

  PMID: 9038671 RESULT

• Hearing SD, Thomas LA, Heaton KW, Hunt L. Effect of cholecystectomy on bowel function: a prospective, controlled study. Gut. 1999 Dec;45(6):889-94. doi: 10.1136/gut.45.6.889.

  PMID: 10562588 RESULT

• Talseth A, Edna TH, Hveem K, Lydersen S, Ness-Jensen E. Quality of life and psychological and gastrointestinal symptoms after cholecystectomy: a population-based cohort study. BMJ Open Gastroenterol. 2017 Apr 1;4(1):e000128. doi: 10.1136/bmjgast-2016-000128. eCollection 2017.

  PMID: 28761686 RESULT

• de Menezes HL, Fireman PA, Wanderley VE, de Menconca AM, Bispo RK, Reis MR. Randomized study for assessment of hypolipidic diet in digestive symptoms immediately following laparoscopic cholecystectomy. Rev Col Bras Cir. 2013 May-Jun;40(3):203-7. doi: 10.1590/s0100-69912013000300007. English, Portuguese.

  PMID: 23912367 RESULT

• Yueh TP, Chen FY, Lin TE, Chuang MT. Diarrhea after laparoscopic cholecystectomy: associated factors and predictors. Asian J Surg. 2014 Oct;37(4):171-7. doi: 10.1016/j.asjsur.2014.01.008. Epub 2014 Mar 17.

  PMID: 24647139 RESULT

• Lamberts MP, Den Oudsten BL, Keus F, De Vries J, van Laarhoven CJ, Westert GP, Drenth JP, Roukema JA. Patient-reported outcomes of symptomatic cholelithiasis patients following cholecystectomy after at least 5 years of follow-up: a long-term prospective cohort study. Surg Endosc. 2014 Dec;28(12):3443-50. doi: 10.1007/s00464-014-3619-2. Epub 2014 Jun 21.

  PMID: 24950724 RESULT

MeSH Terms

Conditions

Dyspepsia; Postoperative Complications

Interventions

Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Luis Oms, PhD

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

• Luis Oms, PhD

  Consorci Sanitari de Terrassa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomly assigned low fat versus balanced diet following cholecystectomy.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 21, 2019
• Study Start: February 20, 2017
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

ES (1)