NCT07517783

"Comparison of Clip-Based and Clipless Laparoscopic Gallbladder Surgery in Controlling Bleeding"

Comparison of Conventional Laparoscopic Cholecystectomy With Clips and Laparoscopic Cholecystectomy Using LigaSure (High Energy Vessel Sealing Devices) Without Clips in Terms of Hemostasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Wah Medical college , POF hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial compared titanium clips and LigaSure (a vessel sealing device) for controlling bleeding during laparoscopic gallbladder surgery. A total of 114 patients were divided into two equal groups, with one group receiving clips and the other treated using LigaSure. The study found that LigaSure significantly reduced intraoperative blood loss and the time required to achieve hemostasis compared to clips, while overall operative time remained similar in both groups. No major complications were observed. The results suggest that LigaSure provides more efficient and reliable bleeding control, likely due to its advanced mechanism of sealing blood vessels. Although clips remain widely used, LigaSure may be a better option, especially in difficult surgical cases. Overall, the study concludes that LigaSure is a safe and effective alternative to titanium clips with superior hemostatic outcomes in laparoscopic cholecystectomy.

Detailed description

This randomized clinical trial was conducted to compare the effectiveness of titanium clips and LigaSure, an advanced bipolar vessel sealing device, in achieving hemostasis during laparoscopic cholecystectomy. A total of 114 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. In Group A, the cystic artery was ligated using conventional titanium clips, while in Group B, vessel sealing was performed using the LigaSure device without the use of clips. This study specifically focused on key intraoperative outcomes, including blood loss and the time required to achieve complete hemostasis. The findings of the study demonstrated that patients in the LigaSure group experienced significantly lower intraoperative blood loss compared to those in the clip group. In addition, the time required to achieve hemostasis was markedly shorter in the LigaSure group, indicating faster and more efficient control of bleeding. Despite these advantages, the total operative time remained comparable between the two groups, suggesting that the use of LigaSure does not prolong the surgical procedure. Importantly, no major intraoperative or postoperative complications were reported in either group, confirming the safety of both techniques. The improved performance of LigaSure in achieving hemostasis can be attributed to its mechanism of action, which involves the application of controlled bipolar energy to seal blood vessels by denaturing collagen and elastin within the vessel walls. This results in a permanent and reliable seal, minimizing the risk of bleeding. In contrast, titanium clips rely on mechanical occlusion, which may be associated with potential issues such as clip slippage or displacement, particularly in difficult surgical conditions. These results suggest that LigaSure provides more efficient and consistent hemostatic control compared to conventional clips. This advantage is particularly relevant in complex cases, such as acute inflammation or dense adhesions, where precise and secure vessel sealing is crucial. Although titanium clips continue to be widely used due to their low cost and accessibility, LigaSure may offer superior outcomes in selected patients. In conclusion, this study establishes that LigaSure is a safe, effective, and reliable alternative to titanium clips for cystic artery control in laparoscopic cholecystectomy. Its use is associated with reduced intraoperative blood loss and faster achievement of hemostasis, making it a valuable tool for improving surgical efficiency and patient outcomes.

Conditions

• Laparoscopic Cholecystectomy Surgery

Interventions

Type	Name	Description
DEVICE	clips	in group A titanium clips are used to seal the cystic artery
DEVICE	ligasure	in group B, ligasure high energy vessel sealing device is used to seal cystic artery

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-05-28
• Completion: 2024-06-30
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Pakistan