Laparoscopic CholecystectomyNCT06470360
Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy
A study testing Surgycal procedure in people with Laparoscopic Cholecystectomy, run by Ulas Aday at 1 site in Turkey (Türkiye).
Trial summary
Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Surgycal procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 27 Aug 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study
Who cannot join
- open surgery emergency cholecystectomy refuse to trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Koşuyolu Higher Specialization Training and Research Hospital
Istanbul, Kartal, 34000
About this study
Official title: Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial
Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.
Read the detailed description
In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Surgycal procedure
- Keywords
- laparoscopic cholecystectomy, cystic duct closure, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgycal procedureOther
surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Single absorbable | Active comparator | Cystic duct to be closed with absorbable single clip Receives: Other: Surgycal procedure |
| Single Hem-o-lok | Active comparator | Cystic duct to be closed with Hem-o-lok single clip Receives: Other: Surgycal procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?
Measured: first 30 day
Secondary outcomes (1)
The costs of the clips used
The costs of the clips used will be determined in dollars using Student's t-test.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Jun 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulas Aday
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ulas Aday, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Investigators
- Mustafa Duman, Principal investigator, Kartal Kosuyolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470360
- Sponsor's protocol ID
- Dicle University
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06470360
- Acronym / sponsor ID
- Dicle University
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- laparoscopic cholecystectomy, cystic duct closure, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ulas AdayOther government
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 24 Jun 2024 (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.
Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.
Detailed description
In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single absorbable | Active comparator | Other: Surgycal procedureCystic duct to be closed with absorbable single clip |
| Single Hem-o-lok | Active comparator | Other: Surgycal procedureCystic duct to be closed with Hem-o-lok single clip |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study
Key exclusion criteria (1 listed)
- open surgery emergency cholecystectomy refuse to trial
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 |
|---|---|---|
| Surgycal proceduresurgical technique | Other | Single Hem-o-lok, Single absorbable |
Primary outcome
Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.
Time frame: first 30 day
Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?
1 secondary outcome
The costs of the clips used
Time frame: one week
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 4 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Mustafa Duman principal investigator
Kartal Kosuyolu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgycal procedure in people with Laparoscopic Cholecystectomy, run by Ulas Aday at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 4 Sep 2025. 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 Turkey (Türkiye). 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?
Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system. (time frame: first 30 day). 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 4 Sep 2025.