An interventional study of laparoscopic cholecystectomy in Acute Cholecystitis, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 176 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
patients treated surgically with laparoscopic cholecystectomy immediately
Procedure: laparoscopic cholecystectomy
patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy
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.
Hospital stay
time spent totally in the hospital; time from admission to discharge from hospital in days
Time frame: 4 to 8 weeks
Costs of treatment
costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
Time frame: 4 to 8 weeks
No study locations are listed for this record.
Plan to share: No — I can share study data only without sharing patient names and protocol numbers.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Sisli Hamidiye Etfal Training and Research Hospital