Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Acute Calculous Cholecystitis Clinical Trial

Official title:

Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477253
• Other study ID #: LC in management of ACC
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Calculous Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy
The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. Review. — View 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. — View Citation

Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Corrêa LD, Alves CB, Guimarães 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. Review. Erratum in: World J Gastrointest Surg. 2017 Oct 27;9(10 ):214. — View 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. — View Citation

Terho PM, Leppäniemi 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. eCollection 2016. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage	compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage	first 72 hours post-operative
Secondary	comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding	compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding	7 days postoperative
Secondary	presence of any wound complication by examining the wound	comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative	within 10 days post-operative