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Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study (CLC)

Primary Purpose

Gall Bladder Stone in Cirrhotics

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LC was done using traditional method
LC was done using harmonic ACE
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gall Bladder Stone in Cirrhotics focused on measuring cirrhotic liver, gall bladder stone

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with liver cirrhosis with symptomatic gall bladder stone

Exclusion Criteria:

  • patients above 80 years old,
  • patients with history of upper laparotomy,
  • patients with common bile duct stones
  • and pregnant females.

Sites / Locations

  • Ayman El Nakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LC was done using traditional method

LC was done using harmonic ACE

Arm Description

LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch.

LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch.

Outcomes

Primary Outcome Measures

time of operation,pain,and bleeding

Secondary Outcome Measures

complications

Full Information

First Posted
November 5, 2009
Last Updated
November 5, 2009
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01009450
Brief Title
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study
Acronym
CLC
Official Title
Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study included group (A) (60 patients with liver cirrhosis and complaining of gall stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS) closure and division of both cystic duct, artery and dissection of gall bladder from liver bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected included duration of operation, postoperative pain, and complications.
Detailed Description
Under general anesthesia, and same antibiotics (3rd generation cephalosporin) Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitoneum at pressure 12 mmHg was used. In group (A) LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch. In group (B) LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch. The Intraoperative parameter observed included duration of the operation, bile escape and volume of blood loss were recorded The patients started oral feeding 8 h postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. The patients were usually discharged after removal of drain, and when the patient surgically free. Postoperative pain was evaluated at 12 h, 24h, 48, 1 w after operation using a visual analog scale (VAS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Bladder Stone in Cirrhotics
Keywords
cirrhotic liver, gall bladder stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LC was done using traditional method
Arm Type
Active Comparator
Arm Description
LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch.
Arm Title
LC was done using harmonic ACE
Arm Type
Active Comparator
Arm Description
LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch.
Intervention Type
Procedure
Intervention Name(s)
LC was done using traditional method
Other Intervention Name(s)
traditional laparoscopic cholecystectomy
Intervention Description
LC was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. Then dissection of gall bladder from its bed by hook using electrocautery technique. Finally we insert abdominal drain in Morrison pouch.
Intervention Type
Procedure
Intervention Name(s)
LC was done using harmonic ACE
Other Intervention Name(s)
clipless laparoscopic cholecystectomy
Intervention Description
LC was done using harmonic ACE (Ethicon Endo-Surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ACE. For closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. And when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. And control of any bleeding from the bed using the active blade of harmonic ACE. Finally we insert abdominal drain in Morrison pouch.
Primary Outcome Measure Information:
Title
time of operation,pain,and bleeding
Time Frame
14 days postoperative
Secondary Outcome Measure Information:
Title
complications
Time Frame
30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with liver cirrhosis with symptomatic gall bladder stone Exclusion Criteria: patients above 80 years old, patients with history of upper laparotomy, patients with common bile duct stones and pregnant females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman el nakeeb, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
ZIP/Postal Code
335111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19882194
Citation
Kandil T, El Nakeeb A, El Hefnawy E. Comparative study between clipless laparoscopic cholecystectomy by harmonic scalpel versus conventional method: a prospective randomized study. J Gastrointest Surg. 2010 Feb;14(2):323-8. doi: 10.1007/s11605-009-1039-8. Epub 2009 Oct 31.
Results Reference
result
PubMed Identifier
19028148
Citation
El-Awadi S, El-Nakeeb A, Youssef T, Fikry A, Abd El-Hamed TM, Ghazy H, Foda E, Farid M. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study. Int J Surg. 2009 Feb;7(1):66-9. doi: 10.1016/j.ijsu.2008.10.013. Epub 2008 Oct 26.
Results Reference
result
PubMed Identifier
15832428
Citation
Ji W, Li LT, Wang ZM, Quan ZF, Chen XR, Li JS. A randomized controlled trial of laparoscopic versus open cholecystectomy in patients with cirrhotic portal hypertension. World J Gastroenterol. 2005 Apr 28;11(16):2513-7. doi: 10.3748/wjg.v11.i16.2513.
Results Reference
result
PubMed Identifier
18977740
Citation
Dery L, Galambos Z, Kupcsulik P, Lukovich P. [Cirrhosis and cholelithiasis. Laparoscopic or open cholecystectomy?]. Orv Hetil. 2008 Nov 9;149(45):2129-34. doi: 10.1556/OH.2008.28450. Hungarian.
Results Reference
result
PubMed Identifier
18831871
Citation
Vu T, Aguilo R, Marshall NC. Clipless technique of laparoscopic cholecystectomy using the harmonic scalpel. Ann R Coll Surg Engl. 2008 Oct;90(7):612. doi: 10.1308/rcsann.2008.90.7.612a. No abstract available.
Results Reference
result
PubMed Identifier
18721011
Citation
Bessa SS, Al-Fayoumi TA, Katri KM, Awad AT. Clipless laparoscopic cholecystectomy by ultrasonic dissection. J Laparoendosc Adv Surg Tech A. 2008 Aug;18(4):593-8. doi: 10.1089/lap.2007.0227.
Results Reference
result

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Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study

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