Major Surgery as a Risk of Gall Stone Disease?

NCT04675190 | Completed

• 1 other identifier: 024-077/078
• Study Type: observational
• Target: 755
• Locations: 1 country
• Sites: 3

Brief Summary

Gall stone disease is one of the most common diseases occurring in the world as well as in our country, Nepal. This disease is problematic to a lot of patients and poses a huge economic burden to the country. Gall stone disease is usually diagnosed by abdominal ultrasonography as echogenic foci that cast an acoustic shadow. The risk factors for the development of gall stones are multiple; age, sex, genetic susceptibility, pregnancy, dyslipidemia, obesity, rapid weight loss, prolonged fasting and parenteral nutrition, spinal cord injury, cirrhosis, hyperbilirubinemia, and Crohn's disease. In cases of prolonged fasting, total parenteral nutrition, and spinal cord injury; biliary stasis due to lack of enteral stimulation is thought to contribute for the development of gall stones.8 Biliary stasis leads to the formation of sludge which consists of mucus, calcium bilirubinate, and cholesterol crystals. It has been established that several drugs viz.fibrates, ceftriaxone, somatostatin analogues and oral contraceptive pill can promote gall stone formation. The elective surgeries are performed after preoperative fasting \>6 hrs. as recommended by different society of anesthesiology. Moreover, fasting continues throughout surgery and few post-operative hours which usually lasts more than 12 hours. Also group of people after major abdominal surgeries frequently develop post-operative hyperbilirubinemia. All these factors after any major surgeries may pose a risk for the development of Gall stones. The major goal of this study is to look if the history of major surgery in the past is one of the etiological factors for the development of gall stone disease. It is a case-control study carried out in the Department of Surgery. It will also help us analyze other multiple epidemiological factors like age, sex, BMI, drugs, lipid profile, family history lifestyle, and dietary factors associated with the disease. The epidemiological data from this study can also help us analyze other confounding and determining factors.

Conditions

Gall Stones (& [Calculus - Gall Bladder]); Surgery

Keywords

Abdominal Surgery; Gall Stones

Outcome Measures

Primary Outcomes (1)

• Odds ratio

  Ratio of the odds for gall stone disease among patient with past history of major abdominal surgery to patient without history of major abdominal surgery and it its significance.

  2 months

Study Arms (2)

Case

Cases will be patients in the department of surgery above 18 years with ultrasound findings of gall stone disease.

Procedure: Major abdominal Surgery

Control

Controls will be patients in the department of surgery above 18 years with ultrasound findings showing evidence of no gallstones

Procedure: Major abdominal Surgery

Interventions

Major abdominal Surgery PROCEDURE

Any surgery performed under general or regional anesthesia and procedures involving abdominal cavity is considered major abdominal surgery and those who have undergone any major abdominal surgery before 6 months from the date of ultrasound findings confirming the presence or absence of gall stone will be considered exposed.

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients above 18 years in the department of surgery in Nepal medical college and teaching hospital, Lumbini Medical College and teaching hospital and Chitwan medical college and teaching hospital

You may qualify if:

• Must be above 18 years of age.

You may not qualify if:

• Liver Cirrhosis
• Hepatobiliary and pancreatic malignancy

Sponsors & Collaborators

• Nepal Medical College and Teaching Hospital: lead
• Lumbini Medical College: collaborator
• Chitwan Medical College: collaborator

Study Sites (3)

Chitwan Medical college and teaching hospital

Bharatpur, Bagmati, 44200, Nepal

Location

Nepal Medical College and teaching hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Lumbini Medical College and teaching hospital

Pālpāthok, Lumbini, 32500, Nepal

Location

Related Publications (6)

• Little JM, Avramovic J. Gallstone formation after major abdominal surgery. Lancet. 1991 May 11;337(8750):1135-7. doi: 10.1016/0140-6736(91)92796-5.

  PMID: 1674022 BACKGROUND

• Bolondi L, Gaiani S, Testa S, Labo G. Gall bladder sludge formation during prolonged fasting after gastrointestinal tract surgery. Gut. 1985 Jul;26(7):734-8. doi: 10.1136/gut.26.7.734.

  PMID: 3894170 BACKGROUND

• Attili AF, Scafato E, Marchioli R, Marfisi RM, Festi D. Diet and gallstones in Italy: the cross-sectional MICOL results. Hepatology. 1998 Jun;27(6):1492-8. doi: 10.1002/hep.510270605.

  PMID: 9620318 BACKGROUND

• Bloch HM, Thornton JR, Heaton KW. Effects of fasting on the composition of gallbladder bile. Gut. 1980 Dec;21(12):1087-9. doi: 10.1136/gut.21.12.1087.

  PMID: 7461468 BACKGROUND

• Hegardt FG, Dam H. The solubility of cholesterol in aqueous solutions of bile salts and lecithin. Z Ernahrungswiss. 1971 Apr;10(3):223-33. doi: 10.1007/BF02020933. No abstract available.

  PMID: 5104113 BACKGROUND

• Lee SP, Maher K, Nicholls JF. Origin and fate of biliary sludge. Gastroenterology. 1988 Jan;94(1):170-6. doi: 10.1016/0016-5085(88)90626-9.

  PMID: 3275565 BACKGROUND

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaurav Dr Katwal, MS

  Chitwan Medical college and teaching hospital, Nepal

  PRINCIPAL INVESTIGATOR

• Neeraj Dr. Thapa, MS

  Lumbini Medical college and teaching hospital, Nepal

  PRINCIPAL INVESTIGATOR

• Sunil Prof. Dr. Shrestha, MS

  Nepal medical college and teaching hospital, Nepal

  STUDY CHAIR

• Harish C Prof. Dr. Neupane, MS

  Chitwan Medical college and teaching hospital, Nepal

  STUDY CHAIR

• Kishor K Prof. Dr. Tamrakar, MS

  Chitwan Medical colllege and teaching hospital, Nepal

  STUDY CHAIR

• Nabin Dr. Pokharel, MCh

  Nepal medical college and teaching hospital, Nepal

  PRINCIPAL INVESTIGATOR

• Biplov Dr. Adhikari, MBBS

  Nepal medical college and teaching hospital, Nepal

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 19, 2020
• Study Start: October 22, 2020
• Primary Completion: November 20, 2021
• Study Completion: April 1, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

NE (3)