NCT03122054

Early Versus Delayed Cholecystectomy

Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: 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. All operations and medical treatments were done by surgeons having work experience \<2 years.

Conditions

• Acute Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	laparoscopic cholecystectomy	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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-11-01
• Completion: 2017-02-15
• First posted: 2017-04-20
• Last updated: 2017-04-25