Appendicitis, SurgeryNCT03930667
Closure of the Appendix Stump in Laparoscopic Appendectomy
A study testing clips and knotting in people with Appendicitis, Surgery, run by Orhan Üreyen.
Trial summary
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis, Surgery
- What is being tested?
- clips and knotting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2015to 31 Dec 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of acute appendicitis
Who cannot join
- under 18 years of age
- other patology in addition to appendiceal pathology
About this study
Official title: Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.
Read the detailed description
Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.
- Conditions
- Appendicitis, Surgery
- Being tested
- clips, knotting
- Keywords
- Appendicitis; Laparoscopic Surgery; Cost Effectiveness
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clipsProcedure or surgery
knottingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| clips | Active comparator | Closure of the appendix stump with hem-o-lok clips Receives: Procedure: clips |
| knotting | Experimental | Closure of the appendix stump with intracorporal knotting. Receives: Procedure: knotting |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost effectiveness
cost of treatment from surgery to discharge
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start25 Mar 2015
- Primary completion1 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis, 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orhan Üreyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Orhan Üreyen, Bozyaka Training and Research Hospital
- Investigators
- Orhan Ureyen, Principal investigator, Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930667
- Sponsor's protocol ID
- 24.03.2015-no:3
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03930667
- Acronym / sponsor ID
- 24.03.2015-no:3
- Conditions
- Appendicitis, Surgery
- Keywords
- Appendicitis; Laparoscopic Surgery; Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Orhan ÜreyenUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Apr 2019 (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.
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.
Detailed description
Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clips | Active comparator | Procedure: clipsClosure of the appendix stump with hem-o-lok clips |
| knotting | Experimental | Procedure: knottingClosure of the appendix stump with intracorporal knotting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of acute appendicitis
Key exclusion criteria (2 listed)
- under 18 years of age
- other patology in addition to appendiceal pathology
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 |
|---|---|---|
| clips | Procedure or surgery | clips |
| knotting | Procedure or surgery | knotting |
Primary outcome
cost effectiveness
Time frame: 4 years
cost of treatment from surgery to discharge
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 30 Apr 2019.
- Individual participant dataSharing planned: Yes
Related trials for Appendicitis, Surgery
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
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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.
Orhan Ureyen principal investigator
Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir
Questions about this trial
What is this clinical trial studying?
A study testing clips and knotting in people with Appendicitis, Surgery, run by Orhan Üreyen.
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 2 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
cost effectiveness (time frame: 4 years). 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 30 Apr 2019.