Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study - Full Text View

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:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

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

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

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:

Mansoura University Hospital This link exits the ClinicalTrials.gov site

Publications:

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. 2009 Oct 31; [Epub ahead of print]

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. Epub 2008 Oct 26.

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.

Déry L, Galambos Z, Kupcsulik P, Lukovich P. [Cirrhosis and cholelithiasis. Laparoscopic or open cholecystectomy?] Orv Hetil. 2008 Nov 9;149(45):2129-34. Hungarian.

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. No abstract available.

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.

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 May 23, 2013

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