Laparoscopic Cholecystectomy SurgeryNCT07517783
"Comparison of Clip-Based and Clipless Laparoscopic Gallbladder Surgery in Controlling Bleeding"
A study testing clips and ligasure in people with Laparoscopic Cholecystectomy Surgery, run by Wah Medical college , POF hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- clips and ligasure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Fully consented patients aged 18 to 60 years
- With any indication of laparoscopic cholecystectomy
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Wah Medical College, POF Hospital Wah cantt
Wāh, Punjab Province, 47040
About this study
Official title: Comparison of Conventional Laparoscopic Cholecystectomy With Clips and Laparoscopic Cholecystectomy Using LigaSure (High Energy Vessel Sealing Devices) Without Clips in Terms of Hemostasis
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.
Read more
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.
Read the 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
- Being tested
- clips, ligasure
- Keywords
- Laparoscopic cholecystectomy, LigaSure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clipsDevice
in group A titanium clips are used to seal the cystic artery
ligasureDevice
in group B, ligasure high energy vessel sealing device is used to seal cystic artery
| Study group | Role | What they receive |
|---|---|---|
| group A: clips | Experimental | Group A is the control arm where patients have the cystic artery sealed with titanium clips during laparoscopic gallbladder surgery, and their bleeding and time to achieve hemostasis are measured for comparison. Receives: Device: clips |
| group B: ligasure | Experimental | Group B is the intervention arm where patients have the cystic artery sealed using LigaSure, and their bleeding and time to achieve hemostasis are measured for comparison with the conventional clip group. Receives: Device: ligasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
The study primarily aimed to compare how much patients bleed during surgery and how fast bleeding is controlled using titanium clips versus LigaSure.
Measured: From surgical incision to completion of surgery
Secondary outcomes (2)
time to achieve hemostasis
this study compares how much intraoperative time of surgery required to control bleeding and achieve hemostasis with titanium clips vs using ligasure
Measured: From onset of cystic artery bleeding to complete cessation of bleeding during surgery
operative time
this study compares duration of surgery using titanium clips vs using ligasure
Measured: From surgical incision to completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Jan 2024
- Primary completion28 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving hemostasis during laparoscopic cholecystectomy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wah Medical college , POF hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517783
- Sponsor's protocol ID
- WMC/ERC/IRB/117
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Laparoscopic Cholecystectomy With Clips and Laparoscopic Cholecystectomy Using LigaSure (High Energy Vessel Sealing Devices) Without Clips in Terms of Hemostasis
- ClinicalTrials.gov ID
- NCT07517783
- Acronym / sponsor ID
- WMC/ERC/IRB/117
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Keywords
- Laparoscopic cholecystectomy, LigaSure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Wah Medical college , POF hospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving hemostasis during laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| group A: clips | Experimental | Device: clipsGroup A is the control arm where patients have the cystic artery sealed with titanium clips during laparoscopic gallbladder surgery, and their bleeding and time to achieve hemostasis are measured for comparison. |
| group B: ligasure | Experimental | Device: ligasureGroup B is the intervention arm where patients have the cystic artery sealed using LigaSure, and their bleeding and time to achieve hemostasis are measured for comparison with the conventional clip group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Fully consented patients aged 18 to 60 years
Key exclusion criteria (3 listed)
- • Who need conversion to open cholecystectomy per-operatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clipsin group A titanium clips are used to seal the cystic artery | Device | group A: clips |
| ligasurein group B, ligasure high energy vessel sealing device is used to seal cystic artery | Device | group B: ligasure |
Primary outcome
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.
2 secondary outcomes
time to achieve hemostasis
Time frame: From onset of cystic artery bleeding to complete cessation of bleeding during surgery
operative time
Time frame: From surgical incision to completion of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Laparoscopic Cholecystectomy Surgery
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Not yet recruiting
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
Cholelithiasis
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
Not yet recruiting
Does the Transversus Abdominis Plane(TAP) Block Effectively Manage Pain After Laparoscopic Cholecystectomy?
TAP Block, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clips and ligasure in people with Laparoscopic Cholecystectomy Surgery, run by Wah Medical college , POF hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: From surgical incision to completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.