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Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

Primary Purpose

Acute Calculous Cholecystitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Laparoscopic cholecystectomy

About this trial

This is an interventional treatment trial for Acute Calculous Cholecystitis focused on measuring Acute calculous cholecystitis, Laparoscopic cholecystectomy, Early laparoscopic cholecystectomy, Late laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LC within 72 hours of disease onset

LC after 72 hours of disease onset

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03477253

First Posted

March 14, 2018

Last Updated

April 26, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03477253

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Calculous Cholecystitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LC within 72 hours of disease onset

Arm Type

Active Comparator

Arm Description

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

Arm Title

LC after 72 hours of disease onset

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic cholecystectomy

Intervention Description

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

Primary Outcome Measure Information:

Title

Comparison between early and late laparoscopic cholecystectomy regarding Operation time

Description

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

Time Frame

intra-operative

Title

Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation

Description

Time Frame

intra-operative

Title

comparison between early and late laparoscopic cholecystectomy regarding post operative pain

Description

Time Frame

within 1month post operative

Title

Duration of postoperative hospital stay

Description

Time Frame

within 2 weeks post-operative

Secondary Outcome Measure Information:

Title

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

Description

compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage

Time Frame

first 72 hours post-operative

Title

comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding

Description

compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding

Time Frame

7 days postoperative

Title

presence of any wound complication by examining the wound

Description

comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative

Time Frame

within 10 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Elmahdy

Organizational Affiliation

Assiut University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gamal Abdel Hameed

Organizational Affiliation

Assiut University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gamal Makhlouf

Organizational Affiliation

Assiut University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assiut University

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

28251270

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.

Results Reference

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PubMed Identifier

28603584

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. Erratum In: World J Gastrointest Surg. 2017 Oct 27;9(10 ):214.

Results Reference

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PubMed Identifier

27891173

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.

Results Reference

background

PubMed Identifier

27429137

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.

Results Reference

background

PubMed Identifier

26521459

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.

Results Reference

background

PubMed Identifier

26264362

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.

Results Reference

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Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

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