AppendectomyNCT06443749
Closure of the Appendiceal Stump
A study testing appendectomy in people with Appendectomy, run by Sezgin Topuz.
Trial summary
Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendectomy
- What is being tested?
- appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with acute appendicitis
Who cannot join
- bleeding diathesis
- cirrhotic acid,
Trial locations and contacts
No sites are listed yet.
Muhammed Alkan contact
About this study
Official title: Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy; Prospective Randomized Trial
Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.
Read the detailed description
Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively. Patients will be randomized into 2 groups: those who will be closed with a polymer endoclip (Group 1) and those who will be closed with an intracorporeal node with a single instrument (Group 2). Data such as age, gender, body mass index, comorbidities, previous abdominal surgeries, medications used by the patients, as well as the presence of ileus, perforation, and diffuse peritonitis will be recorded. After laparoscopic dissection, the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2. The operation times of the patients, the time elapsed after the end of the dissection until the pathology specimen comes out of the skin (to be determined as the closure time), complications such as ileus, intra-abdominal abscess, bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared. Patients will be followed by the corresponding author In both surgical methods, it is routinely used to close the appendiceal stump and in the polymer clip application, a clip with a locking mechanism is used when the stump is tightened with an applicator. In the intracorporial node with one hand, the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument (the other end is kept fixed outside the abdomen)
- Conditions
- Appendectomy
- Being tested
- appendectomy
- Keywords
- Appendectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyProcedure or surgery
the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node
| Study group | Role | What they receive |
|---|---|---|
| group1 | Active comparator | the appendiceal stump will be closed with a polyper homologous clip Receives: Procedure: appendectomy |
| group | Active comparator | the stump will be closed with an intracorporial node with a single instrument in Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
operation time
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
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 AppendectomyStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sezgin Topuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sezgin Topuz, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443749
- Sponsor's protocol ID
- KAHRAMANMARASKSUGCSTOPUZ1.....
- Status last verified
- May 2024
- First submitted
- 11 Dec 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topuz S, Isler A, Cengiz E, Yuzbasioglu MF, Bozan MB, Kale IT. Single-instrument intracorporeal ligation versus polymer clip closure of the appendiceal stump in laparoscopic appendectomy: a prospective randomized study. BMC Surg. 2026 Feb 23;26(1):231. doi: 10.1186/s12893-026-03622-8.
PubMed 41731489
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of the Appendiceal Stump With a Polymer Clip Versus Intracorporeal Ligation With a Single Instrument in Laparoscopic Appendectomy; Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06443749
- Acronym / sponsor ID
- KAHRAMANMARASKSUGCSTOPUZ1.....
- Conditions
- Appendectomy
- Keywords
- Appendectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sezgin TopuzUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 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.
Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.
Detailed description
Patients who are scheduled to undergo laparoscopic appendectomy after the ethics committee approval will be included consecutively. Patients will be randomized into 2 groups: those who will be closed with a polymer endoclip (Group 1) and those who will be closed with an intracorporeal node with a single instrument (Group 2). Data such as age, gender, body mass index, comorbidities, previous abdominal surgeries, medications used by the patients, as well as the presence of ileus, perforation, and diffuse peritonitis will be recorded. After laparoscopic dissection, the appendiceal stump will be closed with a polyper homologous clip in Group 1 and the stump will be closed with an intracorporial node with a single instrument in Group 2. The operation times of the patients, the time elapsed after the end of the dissection until the pathology specimen comes out of the skin (to be determined as the closure time), complications such as ileus, intra-abdominal abscess, bleeding and fistula related to stump closure problems encountered in the postoperative period will be recorded and compared. Patients will be followed by the corresponding author In both surgical methods, it is routinely used to close the appendiceal stump and in the polymer clip application, a clip with a locking mechanism is used when the stump is tightened with an applicator. In the intracorporial node with one hand, the surgical node is made by circulating the tip of the suture material around the appendix with a single instrument (the other end is kept fixed outside the abdomen)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | Active comparator | Procedure: appendectomythe appendiceal stump will be closed with a polyper homologous clip |
| group | Active comparator | Procedure: appendectomythe stump will be closed with an intracorporial node with a single instrument in |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are diagnosed with acute appendicitis
Key exclusion criteria (2 listed)
- bleeding diathesis
- cirrhotic acid,
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 |
|---|---|---|
| appendectomythe appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node | Procedure or surgery | group, group1 |
Primary outcome
operation time
Time frame: 3 months
operation time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 41731489Topuz S, Isler A, Cengiz E, Yuzbasioglu MF, Bozan MB, Kale IT. Single-instrument intracorporeal ligation versus polymer clip closure of the appendiceal stump in laparoscopic appendectomy: a prospective randomized study. BMC Surg. 2026 Feb 23;26(1):231. doi: 10.1186/s12893-026-03622-8.
- 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.
Muhammed Alkan contact
Questions about this trial
What is this clinical trial studying?
A study testing appendectomy in people with Appendectomy, run by Sezgin Topuz.
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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sezgin Topuz (+905370252264, sezgintpz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: 3 months). 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 NCT06443749, 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 5 Jun 2024.