Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

NCT03477253 | Completed

• 1 other identifier: LC in management of ACC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Calculous Cholecystitis

Keywords

Acute calculous cholecystitis; Laparoscopic cholecystectomy; Early laparoscopic cholecystectomy; Late laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (4)

• Comparison between early and late laparoscopic cholecystectomy regarding Operation time

  comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes

  intra-operative

• Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation

  comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy

  intra-operative

• comparison between early and late laparoscopic cholecystectomy regarding post operative pain

  comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics

  within 1month post operative

• Duration of postoperative hospital stay

  comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital

  within 2 weeks post-operative

Secondary Outcomes (3)

• comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage

  first 72 hours post-operative

• comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding

  7 days postoperative

• presence of any wound complication by examining the wound

  within 10 days post-operative

Study Arms (2)

LC within 72 hours of disease onset

ACTIVE COMPARATOR

Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients

Procedure: Laparoscopic cholecystectomy

LC after 72 hours of disease onset

ACTIVE COMPARATOR

Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

LC after 72 hours of disease onset; LC within 72 hours of disease onset

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Initial surgical management planned for immediate laparoscopic cholecystectomy.
• Patients who are fit for laparoscopy and general anesthesia.
• Patient who agree to provide short term outcome data and agree to provide contact information.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (6)

• 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.

  PMID: 28251270 BACKGROUND

• 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.

  PMID: 28603584 BACKGROUND

• 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.

  PMID: 27891173 BACKGROUND

• 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.

  PMID: 27429137 BACKGROUND

• 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.

  PMID: 26521459 BACKGROUND

• 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.

  PMID: 26264362 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Mohamed Elmahdy

  Assiut University

  STUDY CHAIR

• Gamal Abdel Hameed

  Assiut University

  STUDY DIRECTOR

• Gamal Makhlouf

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 26, 2018
• Study Start: October 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

EG (1)