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

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ClinicalTrials.gov Identifier: NCT01009450
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:

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.

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

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)


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study
Study Start Date : August 2008
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. time of operation,pain,and bleeding [ Time Frame: 14 days postoperative ]

Secondary Outcome Measures :
  1. complications [ Time Frame: 30 days postoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009

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