PainNCT05311995
Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?
A study testing Only different trocar sites in people with Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- Only different trocar sites
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 20 Feb 2022
- 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
- patients who underwent laparoscopic appendectomy
Who cannot join
- patients who underwent open surgery and did not want to be involved in the study process
Trial locations and contacts
1 site in 1 country.
About this study
Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated.
- Conditions
- Pain
- Being tested
- Only different trocar sites
- Keywords
- Laparoscopy, Minimally invasive surgery, appendicitis, colorectal
- Medical subject headings
- Pain, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only different trocar sitesProcedure or surgery
Only different trocar sites in literature
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | trocar entry areas:Periumblical, left lower quadrant, suprapubic Receives: Procedure: Only different trocar sites |
| Group 2 | Active comparator | trocar entry areas: Periumblical, left lower quadrant, right lower quadrant Receives: Procedure: Only different trocar sites |
| group 3 | Active comparator | trocar entry areas: Periumblical, right lower quadrant, suprapubic Receives: Procedure: Only different trocar sites |
| Group 4 | Active comparator | trocar entry areas: Periumblical, left lower quadrant, left upper quadrant Receives: Procedure: Only different trocar sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity measure
self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Feb 2021
- Primary completion30 Dec 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Four trocar tecnıques groups in literature
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311995
- Sponsor's protocol ID
- 2021/267
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?
- ClinicalTrials.gov ID
- NCT05311995
- Acronym / sponsor ID
- 2021/267
- Conditions
- Pain
- Keywords
- Laparoscopy, Minimally invasive surgery, appendicitis, colorectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 5 Apr 2022 (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.
Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four trocar tecnıques groups in literature
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Only different trocar sitestrocar entry areas:Periumblical, left lower quadrant, suprapubic |
| Group 2 | Active comparator | Procedure: Only different trocar sitestrocar entry areas: Periumblical, left lower quadrant, right lower quadrant |
| group 3 | Active comparator | Procedure: Only different trocar sitestrocar entry areas: Periumblical, right lower quadrant, suprapubic |
| Group 4 | Active comparator | Procedure: Only different trocar sitestrocar entry areas: Periumblical, left lower quadrant, left upper quadrant |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent laparoscopic appendectomy
Key exclusion criteria (1 listed)
- patients who underwent open surgery and did not want to be involved in the study process
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 |
|---|---|---|
| Only different trocar sitesOnly different trocar sites in literature | Procedure or surgery | Group 1, Group 2, Group 4, group 3 |
Primary outcome
Pain Intensity measure
Time frame: 1 year
self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as
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 5 Apr 2022.
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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.
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 Only different trocar sites in people with Pain, run by Inonu University 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 5 Apr 2022. 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?
Pain Intensity measure (time frame: 1 year). 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 5 Apr 2022.