Major Surgery as a Risk of Gall Stone Disease?

NCT04675190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 755

Last updated 2022-09-28

No results posted yet for this study

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

Interventions

PROCEDURE

Major abdominal Surgery

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.

Sponsors & Collaborators

  • Lumbini Medical College

    collaborator OTHER
  • Chitwan Medical College

    collaborator OTHER
  • Nepal Medical College and Teaching Hospital

    lead OTHER

Principal Investigators

  • Gaurav Dr Katwal, MS · Chitwan Medical college and teaching hospital, Nepal

  • Neeraj Dr. Thapa, MS · Lumbini Medical college and teaching hospital, Nepal

  • Sunil Prof. Dr. Shrestha, MS · Nepal medical college and teaching hospital, Nepal

  • Harish C Prof. Dr. Neupane, MS · Chitwan Medical college and teaching hospital, Nepal

  • Kishor K Prof. Dr. Tamrakar, MS · Chitwan Medical colllege and teaching hospital, Nepal

  • Nabin Dr. Pokharel, MCh · Nepal medical college and teaching hospital, Nepal

  • Biplov Dr. Adhikari, MBBS · Nepal medical college and teaching hospital, Nepal

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2021-11-20
Completion
2022-04-01

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675190 on ClinicalTrials.gov