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

NCT ID: NCT01009450

Last Updated: 2009-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-10-31

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)

Conditions

Gall Bladder Stone in Cirrhotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

LC was done using traditional method

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

LC was done using harmonic ACE

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

traditional laparoscopic cholecystectomy; clipless laparoscopic cholecystectomy

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mansoura University

Principal Investigators

ayman el nakeeb, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Ayman El Nakeeb

Al Mansurah, Mansoura, Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 19882194 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19028148 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15832428 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18977740 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18831871 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18721011 (View on PubMed)

Related Links

http://home.mans.eun.eg

Mansoura University Hospital

Other Identifiers

clipless cholecystectomy

Identifier Type: -

Identifier Source: org_study_id