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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L (n:88) | Other | patients treated surgically with laparoscopic cholecystectomy immediately |
|
| Group D (n:88) | Other | patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 Clipâ„¢ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | time spent totally in the hospital; time from admission to discharge from hospital in days | 4 to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riza Gurhan Isil, MD | Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22570746 | Background | 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. | |
| 20035546 | Result | 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. |
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I can share study data only without sharing patient names and protocol numbers.
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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patients suffering acute pain because of acute cholecystitis
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| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |