Early Versus Delayed Cholecystectomy

NCT ID: NCT03122054

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2017-02-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group L (n:88)

patients treated surgically with laparoscopic cholecystectomy immediately

Group Type: OTHER

laparoscopic cholecystectomy

Intervention Type: 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)

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

Group Type: OTHER

laparoscopic cholecystectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Canan Tulay ISIL

Ast.Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riza Gurhan Isil, MD

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

References

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.

Reference Type: BACKGROUND

PMID: 22570746 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20035546 (View on PubMed)

Other Identifiers

SHEEAH 12.04.2016/1141

Identifier Type: -

Identifier Source: org_study_id