Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

NCT ID: NCT05366907

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholelithiasis Laparoscopic Cholecystectomy Cholecystectomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

Exclusion Criteria

* Age \<10 years,
* Gall Bladder Malignancy,
* Adults with preoperative choledocholithiasis, and
* Perforated gall bladder
Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chitwan Medical College

OTHER

Sponsor Role lead

Responsible Party

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Gaurav Katwal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harish Chandra Neupane, MS

Role: STUDY_CHAIR

CMCTH

Locations

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Chitwan Medical College Teaching Hospital

Bharatpur, Bagmati, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type BACKGROUND
PMID: 21552665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30945646 (View on PubMed)

European Association for the Study of the Liver (EASL). Electronic address: [email protected]. 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.

Reference Type BACKGROUND
PMID: 27085810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24006122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7979854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28779254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28739121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27160289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30439536 (View on PubMed)

Related Links

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Other Identifiers

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CMC-IRC/0770798-271

Identifier Type: -

Identifier Source: org_study_id

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