CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 755 enrolled
Drug / intervention
Major abdominal Surgeryprocedure
Likely dose
Not stated in record
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Search/NCT04675190
NCT04675190N/ACompleted

History of Abdominal Surgery Can be a Risk Factor of Gall Stone Disease? A Case Control Study

Nepal Medical College and Teaching Hospital·observational·Posted Dec 19, 2020·Updated Sep 28, 2022

In Brief

An observational study evaluating Major abdominal Surgery for Gall Stones (& [Calculus - Gall Bladder]) and Surgery. Completed, enrolled 755 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNepal

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 19, 2020
Enrollment StartOct 22, 2020
Primary CompletionNov 20, 2021
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.5 years ago

Interventions

Major abdominal Surgeryprocedure

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.