AppendicitisPhase 3NCT01515293
Single Incision Versus Conventional Laparoscopic Appendectomy
A Phase 3 study testing Single Incision Laparoscopic Appendectomy and Conventional appendectomy in people with Appendicitis, run by Hospital Universitario Virgen de la Arrixaca.
Trial summary
The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Single Incision Laparoscopic Appendectomy and Conventional appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients with suspected acute appendicitis
Who cannot join
- Perforated appendicitis
About this study
Official title: Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy
The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.
Read the detailed description
Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.
- Conditions
- Appendicitis
- Being tested
- Single Incision Laparoscopic Appendectomy, Conventional appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Laparoscopic AppendectomyProcedure or surgery
Conventional appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Incision Laparoscopic Appendectomy | Experimental | Not described Receives: Procedure: Single Incision Laparoscopic Appendectomy |
| Conventional appendectomy | Experimental | Conventional appendectomy Receives: Procedure: Conventional appendectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2010
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dolores Frutos Bernal, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515293
- Sponsor's protocol ID
- HUV-APP-MDFB
- Status last verified
- May 2011
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.
PubMed 23386239
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT01515293
- Acronym / sponsor ID
- HUV-APP-MDFB
- Conditions
- Appendicitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 24 Jan 2012 (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.
The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.
Detailed description
Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Incision Laparoscopic Appendectomy | Experimental | Procedure: Single Incision Laparoscopic Appendectomy |
| Conventional appendectomy | Experimental | Procedure: Conventional appendectomyConventional appendectomy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with suspected acute appendicitis
Key exclusion criteria (1 listed)
- Perforated 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 |
|---|---|---|
| Single Incision Laparoscopic Appendectomy | Procedure or surgery | Single Incision Laparoscopic Appendectomy |
| Conventional appendectomy | Procedure or surgery | Conventional appendectomy |
Primary outcome
Not reported in the source record.
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 24 Jan 2012.
- Derived from this study: PubMed 23386239Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.
Related trials for 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
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single Incision Laparoscopic Appendectomy and Conventional appendectomy in people with Appendicitis, run by Hospital Universitario Virgen de la Arrixaca.
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 24 Jan 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515293, 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 24 Jan 2012.