Clinical trial NCT03477253: Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days
Official title: Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Calculous Cholecystitis
Keywords: Acute calculous cholecystitis
Laparoscopic cholecystectomy
Early laparoscopic cholecystectomy
Late laparoscopic cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms
Primary purpose: TREATMENT

Brief summary: This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

Detailed description: The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Eligibility criteria: Inclusion Criteria:

1. Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count \> 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
2. Initial surgical management planned for immediate laparoscopic cholecystectomy.
3. Patients who are fit for laparoscopy and general anesthesia.
4. Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion Criteria:

1. Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
2. Patients with other associated abdominal pathology.
3. Patients with any previous abdominal surgery or any significant systemic disease.
4. Septic shock.
5. Pregnancy/ Breast-feeding mothers.
6. Participation in an additional drug or device study and inability to offer informed consent.

Primary outcomes:
measure: Comparison between early and late laparoscopic cholecystectomy regarding Operation time
timeFrame: intra-operative
measure: Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation
timeFrame: intra-operative
measure: comparison between early and late laparoscopic cholecystectomy regarding post operative pain
timeFrame: within 1month post operative
measure: Duration of postoperative hospital stay
timeFrame: within 2 weeks post-operative
Secondary outcomes:
measure: comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage
timeFrame: first 72 hours post-operative
measure: comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding
timeFrame: 7 days postoperative
measure: presence of any wound complication by examining the wound
timeFrame: within 10 days post-operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mohamed Elmahdy
role: STUDY_CHAIR
affiliation: Assiut University
name: Gamal Abdel Hameed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Gamal Makhlouf
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuval JB, Mizrahi I, Mazeh H, Weiss DJ, Almogy G, Bala M, Kuchuk E, Siam B, Simanovsky N, Eid A, Pikarsky AJ. Delayed Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis: Is it Time for a Change? World J Surg. 2017 Jul;41(7):1762-1768. doi: 10.1007/s00268-017-3928-4.
citation: Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Correa LD, Alves CB, Guimaraes SF. Acute calculous cholecystitis: Review of current best practices. World J Gastrointest Surg. 2017 May 27;9(5):118-126. doi: 10.4240/wjgs.v9.i5.118.
citation: Terho PM, Leppaniemi AK, Mentula PJ. Laparoscopic cholecystectomy for acute calculous cholecystitis: a retrospective study assessing risk factors for conversion and complications. World J Emerg Surg. 2016 Nov 16;11:54. doi: 10.1186/s13017-016-0111-4. eCollection 2016.
citation: Bagla P, Sarria JC, Riall TS. Management of acute cholecystitis. Curr Opin Infect Dis. 2016 Oct;29(5):508-13. doi: 10.1097/QCO.0000000000000297.
citation: Dudchenko MO, Kravtsiv MI, Lyulka MO, Lyakhovsky VI, Furman DD, Bondar LD. [TREATMENT OF ACUTE CALCULOUS CHOLECYSTITIS: "EARLY" OR "PLANNED" LAPAROSCOPIC CHOLECYSTECTMIVY]. Klin Khir. 2015 Jun;(6):19-21. Ukrainian.
citation: Polo M, Duclos A, Polazzi S, Payet C, Lifante JC, Cotte E, Barth X, Glehen O, Passot G. Acute Cholecystitis-Optimal Timing for Early Cholecystectomy: a French Nationwide Study. J Gastrointest Surg. 2015 Nov;19(11):2003-10. doi: 10.1007/s11605-015-2909-x. Epub 2015 Aug 12.