CClinicalTrials.gg
CompletedNCT05366907Updated Sep 15, 2023

Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

An observational study in Cholelithiasis, Laparoscopic Cholecystectomy and Cholecystectomy, sponsored by Chitwan Medical College. Completed at 1 site in Nepal. Open to participants aged 10 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by Chitwan Medical College · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
345
Ages
10 Years to 75 Years
Sex
All
01

Study summary

In the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstone disease. The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care center.

Read the detailed description

Laparoscopic Cholecystectomy (LC) is the gold standard surgery for symptomatic cholelithiasis with low mortality and morbidity.1,2 However, 1% to 15% of conversion rate to Open Cholecystectomy (OC) during laparoscopic cholecystectomy has been reported.3 Converted cases were associated with increased perioperative time, complication rates, perioperative costs, the length of hospital stay, and a higher 30-day readmission rate.3,4 Conversion was also associated with complications including bile leak, bile duct injury, or bleeding, requiring reoperation or transfusion, and death. A recent detailed critical review found that preoperative variables like male gender, older age, high body mass index, previous abdominal surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with the higher rate of conversion to OC.4 However, data regarding its prevalence lacking in our setting.

The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care centre.

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Conditions studied

  • Cholelithiasis
  • Laparoscopic Cholecystectomy
  • Cholecystectomy
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In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 345 is above the median of 200 across 83 observational studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Chitwan Medical College is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the cases of elective LC admitted at the Department of Surgery at CMCTH were included.

Inclusion criteria

  • All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • Age \<10 years,
  • Gall Bladder Malignancy,
  • Adults with preoperative choledocholithiasis, and
  • Perforated gall bladder
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
345 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention is done

    It is a descriptive cross-sectional study so no groups like case/controls are present. All the cases are included in the study.

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What researchers measure

Primary outcomes

  1. Laparoscopic to Open cholecystectomy

    Demographic details, previous attack of biliary pathology, underlying condition, Huang classification of the biliary system are collected. And conversion rate among these patients were calculated with CR= number of converted surgeries/(number of converted surgeries + number of LC surgeries) × 100) Objectives- To identify the prevalence of conversion rate and, To compare the CR among independent variables- Age, Sex, history of previous attack with dependent variable Open cholecystectomy.

    Time frame: 1 year

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Study locations

1 site
  • Chitwan Medical College Teaching Hospital
    Bharatpur, Bagmati 44207, Nepal
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References and documents

Publications

  • Genc V, Sulaimanov M, Cipe G, Basceken SI, Erverdi N, Gurel M, Aras N, Hazinedaroglu SM. What necessitates the conversion to open cholecystectomy? A retrospective analysis of 5164 consecutive laparoscopic operations. Clinics (Sao Paulo). 2011;66(3):417-20. doi: 10.1590/s1807-59322011000300009. PubMed 21552665 ↗
  • Aziret M, Karaman K, Ercan M, Vargol E, Toka B, Arslan Y, Oter V, Bostanci EB, Parlak E. Early laparoscopic cholecystectomy is associated with less risk of complications after the removal of common bile duct stones by endoscopic retrograde cholangiopancreatography. Turk J Gastroenterol. 2019 Apr;30(4):336-344. doi: 10.5152/tjg.2018.18272. PubMed 30945646 ↗
  • European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available. PubMed 27085810 ↗
  • Deka P, Islam M, Jindal D, Kumar N, Arora A, Negi SS. Analysis of biliary anatomy according to different classification systems. Indian J Gastroenterol. 2014 Jan;33(1):23-30. doi: 10.1007/s12664-013-0371-9. Epub 2013 Sep 5. PubMed 24006122 ↗
  • Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81. PubMed 7979854 ↗
  • Coffin SJ, Wrenn SM, Callas PW, Abu-Jaish W. Three decades later: investigating the rate of and risks for conversion from laparoscopic to open cholecystectomy. Surg Endosc. 2018 Feb;32(2):923-929. doi: 10.1007/s00464-017-5767-7. Epub 2017 Aug 4. PubMed 28779254 ↗
  • Hu ASY, Menon R, Gunnarsson R, de Costa A. Risk factors for conversion of laparoscopic cholecystectomy to open surgery - A systematic literature review of 30 studies. Am J Surg. 2017 Nov;214(5):920-930. doi: 10.1016/j.amjsurg.2017.07.029. Epub 2017 Jul 21. PubMed 28739121 ↗
  • Philip Rothman J, Burcharth J, Pommergaard HC, Viereck S, Rosenberg J. Preoperative Risk Factors for Conversion of Laparoscopic Cholecystectomy to Open Surgery - A Systematic Review and Meta-Analysis of Observational Studies. Dig Surg. 2016;33(5):414-23. doi: 10.1159/000445505. Epub 2016 May 5. PubMed 27160289 ↗
  • van de Graaf FW, Zaimi I, Stassen LPS, Lange JF. Safe laparoscopic cholecystectomy: A systematic review of bile duct injury prevention. Int J Surg. 2018 Dec;60:164-172. doi: 10.1016/j.ijsu.2018.11.006. Epub 2018 Nov 12. PubMed 30439536 ↗

Related links

Individual participant data

Plan to share: Undecided — Data can be provided to the individual interested researcher only on the basis of sound interest in research with good moral intention.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05366907
Lead sponsor
Chitwan Medical College
Responsible party
Gaurav Katwal (Principal Investigator, Chitwan Medical College) — Principal investigator
First posted
May 9, 2022
Start date
Jun 1, 2020
Primary completion
May 30, 2021
Completion
Dec 30, 2021
Last update
Sep 15, 2023

Study contacts

Harish Chandra Neupane, MS
study chair · CMCTH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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