Cholecystectomy, Laparoscopic, Cholecystitis, Gall Stones (& [Calculus - Gall Bladder])
Conditions
Keywords
laparoscopic cholecystectomy, clipless cholecystectomy, harmonic scalpel
Brief summary
This randomized controlled trial compares the operative outcomes of clipless laparoscopic cholecystectomy using a harmonic scalpel (HS) versus conventional clip-based laparoscopic cholecystectomy (CLC) in patients with gallstone disease. The primary goals are to determine if the clipless HS technique reduces operative time and intraoperative blood loss. Secondary outcomes include the length of postoperative hospital stay and the rate of port-site infections.
Detailed description
Conventional laparoscopic cholecystectomy (CLC) uses metal clips to control the cystic duct and artery. Potential complications include clip slippage, which can lead to bleeding or bile leak, and clips acting as a nidus for future stone formation. The harmonic scalpel (HS) uses ultrasonic energy to simultaneously cut and coagulate tissue, allowing for dissection and sealing of vessels without clips. This single-center randomized controlled trial, conducted at Services Hospital, Lahore, Pakistan, enrolled 158 adults scheduled for elective laparoscopic cholecystectomy. Participants were randomly assigned to either undergo a clipless cholecystectomy with a harmonic scalpel (Group A) or a conventional clip-based cholecystectomy with monopolar electrocautery (Group B). All procedures were performed by the same experienced surgical team. The study aims to provide evidence on the safety and efficiency of the clipless HS technique in a high-volume public hospital setting.
Interventions
PROCEDUREClipless Laparoscopic Cholecystectomy with Harmonic Scalpel
Patients in this arm undergo a clipless laparoscopic cholecystectomy using a harmonic scalpel. Dissection of Calot's triangle is performed with the harmonic scalpel. The cystic duct and cystic artery are occluded and divided using the harmonic shear without the application of any metal clips. The harmonic scalpel is used on power setting 2 for closure and division of the cystic pedicle. The gallbladder is dissected from the liver bed using the harmonic scalpel on power setting 5 to achieve hemostasis.
Patients in this arm undergo a conventional laparoscopic cholecystectomy. Calot's triangle is dissected using standard instruments and monopolar electrocautery. The cystic duct and cystic artery are individually controlled with metal clips (two clips applied proximally toward the common bile duct / hepatic artery side and one clip distally on the specimen side) and divided with laparoscopic scissors. The gallbladder is dissected from the liver bed using a monopolar hook
Sponsors
Services Hospital, Lahore
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20-70 years. * Diagnosis of gallstone disease confined to the gallbladder. * Scheduled for elective laparoscopic cholecystectomy.
Exclusion criteria
* ASA (American Society of Anesthesiologists) physical status class III or IV. * Renal dysfunction (serum creatinine \> 2.0 mg/dL). * Coagulopathy (PT \>1 s above control, aPTT \>33 s, INR \>1.5). * Pregnancy. * Presence of common bile duct stones. * Previous upper abdominal surgery or laparotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time in minutes | 120 minutes | Defined as the time from skin incision to the completion of skin closure, measured in minutes. |
| Intraoperative Blood Loss in ml | 120 minutes | Defined as the total volume of blood collected in suction canisters after subtracting the volume of irrigation fluid used, measured in milliliters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Postoperative Hospital Stay in days | 6 days | Defined as the number of days from operation to discharge when the patient can tolerate oral intake and pain is well-controlled with oral medication. |
| Port-Site Infection Rate | 7-10 days | Defined as the presence of fever (\>100°F) with pain and purulent discharge from any port site. |
Countries
Pakistan
Contacts
STUDY_DIRECTORAwais Amjad, MBBS, FCPS
Services Institute of Medical Sciences
Outcome results
None listed