AppendicitisNCT01260064
Open Appendectomy Versus Laparoscopic Appendectomy
A study testing Open appendectomy, Laparoscopic appendectomy with metal endoclips and Laparoscopic appendectomy with suture ligation in people with Appendicitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
1. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Open appendectomy, Laparoscopic appendectomy with metal endoclips and Laparoscopic appendectomy with suture ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2010to May 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients with a preoperative diagnosis of acute appendicitis
Who cannot join
- The patients who are not volunteered to join the study
- The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
- The patients who have additional pathologies accompanying acute appendicitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: The Outcomes of Various Appendectomy Techniques in a High-volume Center.
- Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.
Read the detailed description
The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.
- Conditions
- Appendicitis
- Being tested
- Open appendectomy, Laparoscopic appendectomy with metal endoclips, Laparoscopic appendectomy with suture ligation
- Keywords
- Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open appendectomyProcedure or surgery
Also called Open technique
The subjects will have traditional open appendectomy procedure.
Laparoscopic appendectomy with metal endoclipsProcedure or surgery
Also called Metal endoclip
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
Laparoscopic appendectomy with suture ligationProcedure or surgery
Also called Intracorporeal suture ligation
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
| Study group | Role | What they receive |
|---|---|---|
| Open appendectomy | Active comparator | The subjects will have open appendectomy procedure. Receives: Procedure: Open appendectomy |
| Metal endoclip | Active comparator | The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips. Receives: Procedure: Laparoscopic appendectomy with metal endoclips |
| Intracorporeal suture ligation | Active comparator | The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation. Receives: Procedure: Laparoscopic appendectomy with suture ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life.
Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.
Measured: 1 month
Secondary outcomes (1)
Cost-effectivity
The study will reveal which procedure for appendectomy is the most cost-effective one.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Investigators
- Halil Alis, MD, Study director, Dr. Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260064
- Sponsor's protocol ID
- Frumious
- Status last verified
- May 2011
- First submitted
- 13 Dec 2010
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Various Appendectomy Techniques in a High-volume Center.
- ClinicalTrials.gov ID
- NCT01260064
- Acronym / sponsor ID
- Frumious
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- 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 may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.
Detailed description
The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open appendectomy | Active comparator | Procedure: Open appendectomyThe subjects will have open appendectomy procedure. |
| Metal endoclip | Active comparator | Procedure: Laparoscopic appendectomy with metal endoclipsThe subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips. |
| Intracorporeal suture ligation | Active comparator | Procedure: Laparoscopic appendectomy with suture ligationThe subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with a preoperative diagnosis of acute appendicitis
Key exclusion criteria (3 listed)
- The patients who are not volunteered to join the study
- The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
- The patients who have additional pathologies accompanying acute appendicitis
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 |
|---|---|---|
| Open appendectomyAlso: Open techniqueThe subjects will have traditional open appendectomy procedure. | Procedure or surgery | Open appendectomy |
| Laparoscopic appendectomy with metal endoclipsAlso: Metal endoclipThe subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips. | Procedure or surgery | Metal endoclip |
| Laparoscopic appendectomy with suture ligationAlso: Intracorporeal suture ligationThe subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation. | Procedure or surgery | Intracorporeal suture ligation |
Primary outcome
Quality of life.
Time frame: 1 month
Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.
1 secondary outcome
Cost-effectivity
Time frame: 1 month
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 26 May 2011.
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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.
Halil Alis, MD study director
Dr. Sadi Konuk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open appendectomy, Laparoscopic appendectomy with metal endoclips and Laparoscopic appendectomy with suture ligation in people with Appendicitis, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 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 26 May 2011. 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?
Quality of life. (time frame: 1 month). 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 26 May 2011.