Acute AppendicitisNCT06897709
"Stump-First" Approach in Laparoscopic Appendectomy
A study testing Classic Approach in Laparoscopic Appendectomy and Stump first Approach in Laparoscopic Appendectomy in people with Acute Appendicitis and Acute Appendicitis with Appendix Abscess, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to compare the standard laparoscopic appendectomy with the "Stump-First Approach" technique in patients diagnosed with acute appendicitis in terms of intraoperative and postoperative complications that may occur (injury, intra-abdominal abscess, postoperative fever, and infection parameters). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Appendicitis, Acute Appendicitis with Appendix Abscess
- What is being tested?
- Classic Approach in Laparoscopic Appendectomy and Stump first Approach in Laparoscopic Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 15 May 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute appendicitis
Who cannot join
- exist of pregnancy, exist of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Objective: This study aims to compare the standard laparoscopic appendectomy with the "Stump-First Approach" technique in patients diagnosed with acute appendicitis in terms of intraoperative and postoperative complications that may occur (injury, intra-abdominal abscess, postoperative fever, and infection parameters).
Read the detailed description
The patients were randomly assigned to two groups: Group 1 underwent laparoscopic appendectomy using the standard approach, and Group 2 underwent laparoscopic appendectomy using the Stump-First Approach. Randomization was performed using a specialized computer program. Pregnant women, individuals under 18 years of age, incidental appendectomies, patients with a history of plastron appendicitis, those with malignant pathology results, patients with additional pathologies aside from appendicitis, and those who underwent conventional appendectomy were excluded from the study. All operations were performed under general anesthesia. A single dose of cefazolin (2g, intravenous) was routinely administered as prophylactic antibiotic therapy during anesthesia induction. All surgeries were conducted under the supervision of a surgical specialist with at least five years of experience.
Surgical Technique: For both groups, access to the abdomen was achieved from below the umbilicus, through the use of a Veress needle for patients with no prior abdominal surgery, and through the Hasson technique for those with a history of abdominal surgery; establishing pneumoperitoneum, the abdomen was inserted with an initial 10 mm trocar. Under direct vision with a 30-degree optical aid, a 5 mm trocar was placed in the suprapubic region and a 10mm trocar in the left lower quadrant. The operating table was positioned at 15-20° Trendelenburg and 10-15° left lateral tilt.
In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag.
For Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag. In both groups, the 10 mm trocar insertion site fascia was closed with 0 polyglactin and the skin with 3/0 polypropylene.
The groups were compared in infection status (white blood cell (WBC) count, C-reactive protein (CRP) levels, proportional changes in these parameters, additional antibiotic requirements). The sample size for the study was calculated using the G*Power 3.1 statistical power analysis program. Assuming α=0.05, power (1-β)=0.95, the case-intervention group allocation ratio 1:1, and a high effect size (Cohen's d=0.97) with a two-tailed analysis, the required sample size was determined to be 60 patients, with 30 in each group.
- Being tested
- Classic Approach in Laparoscopic Appendectomy, Stump first Approach in Laparoscopic Appendectomy
- Keywords
- appendectomy, laparoscopic appendectomy, surgical tecnic
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Approach in Laparoscopic AppendectomyProcedure or surgery
underwent laparoscopic appendectomy using the standard approach
Stump first Approach in Laparoscopic AppendectomyProcedure or surgery
Stump first Approach in Laparoscopic Appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1: underwent laparoscopic appendectomy using the standard approach | Active comparator | In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag. Receives: Procedure: Classic Approach in Laparoscopic Appendectomy |
| Group 2 underwent laparoscopic appendectomy using the Stump-First Approach | Active comparator | Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag Receives: Procedure: Stump first Approach in Laparoscopic Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants compared in infection status
The groups were compared in infection status (WBC, CRP, additional antibiotic requirements)
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 posted27 Mar 2025
- Study start1 Apr 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Orhan Üreyen, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897709
- Sponsor's protocol ID
- 10/05/2023, numbered 2023/61
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2025
- Last updated
- 27 Mar 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Stump-First" Approach in Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT06897709
- Acronym / sponsor ID
- 10/05/2023, numbered 2023/61
- Keywords
- appendectomy, laparoscopic appendectomy, surgical tecnic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Mar 2025 (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.
Objective: This study aims to compare the standard laparoscopic appendectomy with the "Stump-First Approach" technique in patients diagnosed with acute appendicitis in terms of intraoperative and postoperative complications that may occur (injury, intra-abdominal abscess, postoperative fever, and infection parameters).
Detailed description
The patients were randomly assigned to two groups: Group 1 underwent laparoscopic appendectomy using the standard approach, and Group 2 underwent laparoscopic appendectomy using the Stump-First Approach. Randomization was performed using a specialized computer program. Pregnant women, individuals under 18 years of age, incidental appendectomies, patients with a history of plastron appendicitis, those with malignant pathology results, patients with additional pathologies aside from appendicitis, and those who underwent conventional appendectomy were excluded from the study. All operations were performed under general anesthesia. A single dose of cefazolin (2g, intravenous) was routinely administered as prophylactic antibiotic therapy during anesthesia induction. All surgeries were conducted under the supervision of a surgical specialist with at least five years of experience.
Surgical Technique: For both groups, access to the abdomen was achieved from below the umbilicus, through the use of a Veress needle for patients with no prior abdominal surgery, and through the Hasson technique for those with a history of abdominal surgery; establishing pneumoperitoneum, the abdomen was inserted with an initial 10 mm trocar. Under direct vision with a 30-degree optical aid, a 5 mm trocar was placed in the suprapubic region and a 10mm trocar in the left lower quadrant. The operating table was positioned at 15-20° Trendelenburg and 10-15° left lateral tilt.
In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag.
For Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag. In both groups, the 10 mm trocar insertion site fascia was closed with 0 polyglactin and the skin with 3/0 polypropylene.
The groups were compared in infection status (white blood cell (WBC) count, C-reactive protein (CRP) levels, proportional changes in these parameters, additional antibiotic requirements). The sample size for the study was calculated using the G*Power 3.1 statistical power analysis program. Assuming α=0.05, power (1-β)=0.95, the case-intervention group allocation ratio 1:1, and a high effect size (Cohen's d=0.97) with a two-tailed analysis, the required sample size was determined to be 60 patients, with 30 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: underwent laparoscopic appendectomy using the standard approach | Active comparator | Procedure: Classic Approach in Laparoscopic AppendectomyIn Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag. |
| Group 2 underwent laparoscopic appendectomy using the Stump-First Approach | Active comparator | Procedure: Stump first Approach in Laparoscopic AppendectomyGroup 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute appendicitis
Key exclusion criteria (1 listed)
- exist of pregnancy, exist of cancer
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 |
|---|---|---|
| Classic Approach in Laparoscopic Appendectomyunderwent laparoscopic appendectomy using the standard approach | Procedure or surgery | Group 1: underwent laparoscopic appendectomy using the standard approach |
| Stump first Approach in Laparoscopic AppendectomyStump first Approach in Laparoscopic Appendectomy | Procedure or surgery | Group 2 underwent laparoscopic appendectomy using the Stump-First Approach |
Primary outcome
The number of participants compared in infection status
Time frame: 1 year
The groups were compared in infection status (WBC, CRP, additional antibiotic requirements)
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 27 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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 Classic Approach in Laparoscopic Appendectomy and Stump first Approach in Laparoscopic Appendectomy in people with Acute Appendicitis and Acute Appendicitis with Appendix Abscess, run by Izmir City Hospital 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 27 Mar 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?
The number of participants compared in infection status (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 27 Mar 2025.