Early Versus Delayed Cholecystectomy

NCT03122054 | Completed DMC

• 1 other identifier: SHEEAH 12.04.2016/1141
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.

Conditions

Acute Cholecystitis

Keywords

Laparoscopic Cholecystectomy, Delayed Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  time spent totally in the hospital; time from admission to discharge from hospital in days

  4 to 8 weeks

Secondary Outcomes (1)

• Costs of treatment

  4 to 8 weeks

Study Arms (2)

Group L (n:88)

OTHER

patients treated surgically with laparoscopic cholecystectomy immediately

Procedure: laparoscopic cholecystectomy

Group D (n:88)

OTHER

patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy PROCEDURE

First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision.

Group D (n:88); Group L (n:88)

Eligibility Criteria

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

You may qualify if:

• patients suffering acute cholecystitis in their first 72 hours of pain

You may not qualify if:

• clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin \>2gr/dl, elevated transaminases (\>100 u/l), and cholestatic enzymes (gamma glutamyl transferase \>50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Related Publications (2)

• Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.

  PMID: 22570746 BACKGROUND

• Gurusamy K, Samraj K, Gluud C, Wilson E, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 2010 Feb;97(2):141-50. doi: 10.1002/bjs.6870.

  PMID: 20035546 RESULT

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; 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 Officials

• Riza Gurhan Isil, MD

  Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

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: Ast.Clinical Professor

Model Details: patients suffering acute pain because of acute cholecystitis

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 20, 2017
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 15, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share