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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01009450
First received: November 5, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Gall Bladder Stone in Cirrhotics
Procedure: LC was done using traditional method
Procedure: LC was done using harmonic ACE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • time of operation,pain,and bleeding [ Time Frame: 14 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LC was done using traditional method
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.
Procedure: LC was done using traditional method
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.
Other Name: traditional laparoscopic cholecystectomy
Active Comparator: LC was done using harmonic ACE
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.
Procedure: LC was done using harmonic ACE
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.
Other Name: clipless laparoscopic cholecystectomy

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)

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01009450

Locations
Egypt
Ayman El Nakeeb
Mansoura, Egypt, 335111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ayman el nakeeb, MD Mansoura University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT01009450     History of Changes
Other Study ID Numbers: clipless cholecystectomy
Study First Received: November 5, 2009
Last Updated: November 5, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
cirrhotic liver, gall bladder stone

Additional relevant MeSH terms:
Urinary Bladder Calculi
Cholelithiasis
Cholecystolithiasis
Gallstones
Urinary Bladder Diseases
Urologic Diseases
Urinary Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on September 18, 2014