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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01009450
Acronym
CLC
Enrollment
120
Registered
2009-11-06
Start date
2008-08-31
Completion date
2009-10-31
Last updated
2009-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Bladder Stone in Cirrhotics

Keywords

cirrhotic liver, gall bladder stone

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)

Interventions

PROCEDURELC 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.

PROCEDURELC 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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
time of operation,pain,and bleeding14 days postoperative

Secondary

MeasureTime frame
complications30 days postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026