Acute AppendicitisNCT04387370
The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
An observational study of Acute Appendicitis, run by Ulas Aday at 1 site in Turkey (Türkiye).
Trial summary
Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use, binding with endoloop and nonabsorbable clip are the most common methods. Although the stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the learning curve and surgical time are longer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Appendicitis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 18 Apr 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on for acute appendicitis
Who may be able to join
- diagnosis of acute appendicitis
- Performing laparoscopic surgery
- Patients with an ASA score of I-II-III
Who cannot join
- Appendectomies with the patient's refusal to participate in the study
- Open surgery
- Primary pathology without appendicitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dicle University Medical of School, Department of Gastrointestinal Surgery
Diyarbakır, 21280
About this study
Official title: Comparison of Single and Double Hem-o-log Clips in Laparoscopic Appendectomy
Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use, binding with endoloop and nonabsorbable clip are the most common methods. Although the stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the learning curve and surgical time are longer. Nonabsorbable clip application which has been used recently; Urethra was also used in appendectomy after its safety has been proven by large studies to close cystic ducts and vascular structures. Its advantages such as low cost, no need for a learning curve and shortening the surgical time have increased the frequency of use.In this prospective observational study; It will be aimed to investigate the effects of stump closure methods applied in laparoscopic appendectomy on short-term clinical results. In addition, the factors that determine the surgeon's stump closure method and cost results will be tried to be determined.
Read the detailed description
Detailed explanation will be made later if necessary.
- Conditions
- Acute Appendicitis
- Keywords
- Laparoscopic appendectomy, Hem-o-lok clip, stump closure
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Is it safe to close the appendix stump with a single hem-o-lok clip?
Complications of patients using single and double clips will be compared according to Clavien-Dindo scoring system.
Measured: one year
Secondary outcomes (1)
The effect of single and double hem-o-lok clips on cost in laparoscopic appendectomy
With the use of a single clip, surgery costs are expected to be less in dollars.Student's t-test will be used for cost analysis.
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 posted13 May 2020
- Study start1 Sep 2020
- Primary completion31 Jan 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 30 Days
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
- Abdullah Oğuz, MD, Principal investigator, Dicle University Medical of SchoolUlaş Aday, MD, Study chair, Dicle University Medical of SchoolMehmet veysi Bahadır, MD, Study director, Dicle University Medical of School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387370
- Sponsor's protocol ID
- 'KartalH'
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2020
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since there are no plans yet, planning will be done later.
Publications
Aday U, Cetin E, Kafadar MT, Oguz A, Bahadir MV, Ulger BV, Gedik E, Girgin S, Yilmaz M. Single versus double Hem-o-lok clips to secure the apendiceal stump during laparoscopic appendectomy: a prospective randomized multicentric clinical trial. Langenbecks Arch Surg. 2024 Mar 8;409(1):89. doi: 10.1007/s00423-024-03281-4.
PubMed 38457041
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single and Double Hem-o-log Clips in Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT04387370
- Acronym / sponsor ID
- 'KartalH'
- Conditions
- Acute Appendicitis
- Keywords
- Laparoscopic appendectomy, Hem-o-lok clip, stump closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ulas AdayOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 13 May 2020 (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.
Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use, binding with endoloop and nonabsorbable clip are the most common methods. Although the stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the learning curve and surgical time are longer. Nonabsorbable clip application which has been used recently; Urethra was also used in appendectomy after its safety has been proven by large studies to close cystic ducts and vascular structures. Its advantages such as low cost, no need for a learning curve and shortening the surgical time have increased the frequency of use.In this prospective observational study; It will be aimed to investigate the effects of stump closure methods applied in laparoscopic appendectomy on short-term clinical results. In addition, the factors that determine the surgeon's stump closure method and cost results will be tried to be determined.
Detailed description
Detailed explanation will be made later if necessary.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on for acute appendicitis
Key inclusion criteria (3 listed)
- diagnosis of acute appendicitis
- Performing laparoscopic surgery
- Patients with an ASA score of I-II-III
Key exclusion criteria (3 listed)
- Appendectomies with the patient's refusal to participate in the study
- Open surgery
- Primary pathology without appendicitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Is it safe to close the appendix stump with a single hem-o-lok clip?
Time frame: one year
Complications of patients using single and double clips will be compared according to Clavien-Dindo scoring system.
1 secondary outcome
The effect of single and double hem-o-lok clips on cost in laparoscopic appendectomy
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 19 Apr 2023.
- Derived from this study: PubMed 38457041Aday U, Cetin E, Kafadar MT, Oguz A, Bahadir MV, Ulger BV, Gedik E, Girgin S, Yilmaz M. Single versus double Hem-o-lok clips to secure the apendiceal stump during laparoscopic appendectomy: a prospective randomized multicentric clinical trial. Langenbecks Arch Surg. 2024 Mar 8;409(1):89. doi: 10.1007/s00423-024-03281-4.
- Individual participant dataSharing planned: No. Since there are no plans yet, planning will be done later.
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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.
Abdullah Oğuz, MD principal investigator
Dicle University Medical of School
Ulaş Aday, MD study chair
Dicle University Medical of School
Mehmet veysi Bahadır, MD study director
Dicle University Medical of School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, 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 3 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 19 Apr 2023. 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?
Is it safe to close the appendix stump with a single hem-o-lok clip? (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387370, which also lists 1 linked publication.
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 19 Apr 2023.