Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis

NCT05352087 | Completed

• 1 other identifier: 1/134
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade IIcholecystitis according to Tokyo 2018 guidelines.

Conditions

Cholecystitis

Keywords

Acute cholecystitis; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• mortality, morbidity and difficult cholecystectomy rates between two groups

  effect of the timing on mortality, morbidity and difficult cholecystectomy in patients with acute cholecystitis

  patients will be followed up to the first 30 day period from discharge.

Study Arms (2)

early cholecystectomy

ACTIVE COMPARATOR

In early cholecystectomy group after antibiotherapy was started with ceftriaxone and metronidazole, laparoscopic cholecystectomy was performed in the first 7 days following the hospitalization.

Procedure: Laparoscopic cholecystectomy

delayed cholecystectomy

ACTIVE COMPARATOR

Patients who accepted delayed surgery were also given the same antibiotherapy and operated after 6 weeks following their discharge

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.

delayed cholecystectomy; early cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Grade II cholecystitis according to Tokyo 2018 guidelines
• Patients older than 18 years of age

You may not qualify if:

• Patients younger than 18 years of age
• Patients diagnosed with choledocholithiasis
• Patients with Grade I or Grade III cholecystitis
• Pregnancy
• Patients unable to comply with the treatment or who could not consent to the treatment due to their mental state
• Patients that refused the treatment

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Izmir Tepecik Training and Research Hospital

Izmir, Konak, 35180, Turkey (Türkiye)

Location

Related Publications (3)

• Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.

  PMID: 29032636 RESULT

• Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF; Tokyo Guidelines Revision Committee. New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines. J Hepatobiliary Pancreat Sci. 2012 Sep;19(5):578-85. doi: 10.1007/s00534-012-0548-0.

  PMID: 22872303 RESULT

• Borzellino G, Sauerland S, Minicozzi AM, Verlato G, Di Pietrantonj C, de Manzoni G, Cordiano C. Laparoscopic cholecystectomy for severe acute cholecystitis. A meta-analysis of results. Surg Endosc. 2008 Jan;22(1):8-15. doi: 10.1007/s00464-007-9511-6. Epub 2007 Aug 18.

  PMID: 17704863 RESULT

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Consultant

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 28, 2022
• Study Start: December 14, 2019
• Primary Completion: June 14, 2021
• Study Completion: July 14, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)