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Completed

NCT Number: NCT07517783

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wah Medical College, POF Hospital Wah cantt

Wāh, Punjab Province, 47040, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Fully consented patients aged 18 to 60 years
  • With any indication of laparoscopic cholecystectomy

Exclusion criteria

  • • Who need conversion to open cholecystectomy per-operatively
  • With bleeding diathesis (inherited or acquired bleeding disorders)
  • Who need concomitant complicated procedure during surgery (e.g., Whipple procedure, or stoma formation)

Treatment and study plan

Clips

Device

in group A titanium clips are used to seal the cystic artery

LIGASURE

Device

in group B, ligasure high energy vessel sealing device is used to seal cystic artery

Primary outcomes

  1. intraoperative blood loss

    Time frame: From surgical incision to completion of surgery

    The study primarily aimed to compare how much patients bleed during surgery and how fast bleeding is controlled using titanium clips versus LigaSure.

Secondary outcomes

  1. time to achieve hemostasis

    Time frame: From onset of cystic artery bleeding to complete cessation of bleeding during surgery

    this study compares how much intraoperative time of surgery required to control bleeding and achieve hemostasis with titanium clips vs using ligasure

  2. operative time

    Time frame: From surgical incision to completion of surgery

    this study compares duration of surgery using titanium clips vs using ligasure

Sponsors and collaborators

Lead sponsor

Wah Medical college , POF hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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