Acute AppendicitisPhase 3AMUSINGNCT01720082
Laparoscopic Appendectomy by Multi-port vs Single Port.
A Phase 3 study testing Single incision laparoscopic appendectomy and Multiport laparoscopic appendectomy in people with Acute Appendicitis, run by Associazione Chirurghi Ospedalieri Italiani at 1 site in Italy.
Trial summary
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Single incision laparoscopic appendectomy and Multiport laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Feb 2014
- 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 14 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- age: 14-60
- American Society of Anesthesiologists (ASA) score: I-III
- absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
- diagnosis: acute appendicitis with surgical indication
Who cannot join
- Complicated appendicitis after exploration or previously diagnosed (CT)
- Psychical inability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.
- Conditions
- Acute Appendicitis
- Being tested
- Single incision laparoscopic appendectomy, Multiport laparoscopic 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
Also called SILA
A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
Multiport laparoscopic appendectomyProcedure or surgery
Also called LA
Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
| Study group | Role | What they receive |
|---|---|---|
| Single incision laparoscopic appendectomy | Active comparator | Acute appendicitis with surgical indication Receives: Procedure: Single incision laparoscopic appendectomy |
| Multiport Laparoscopic appendectomy | Active comparator | Acute appendicitis with surgical indication Receives: Procedure: Multiport laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity and mortality
Measured: 30 days
Secondary outcomes (6)
Post-operative pain score
Visual Analogic Scale (VAS scale)
Measured: 3 days
Operative time
Measured: 1 day
Cosmetic result
VAS scale
Measured: 6 months
Post-operative hospital stay
Measured: 7 days
Incision related morbidity
during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias
Measured: 6 months
Quality of life
Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionAug 2013 (estimated)
- Study completionFeb 2014 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Chirurghi Ospedalieri Italiani
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
- Responsible party
- Principal investigator, Nereo Vettoretto, Associazione Chirurghi Ospedalieri Italiani
- Investigators
- Nereo Vettoretto, MD, Study chair, ACOI - SICEFerdinando Agresta, MD, Study chair, ACOI - SICELuigi Boni, MD, FACS, Study chair, SICE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720082
- Sponsor's protocol ID
- ACOI - SICE
- Acronym
- AMUSING
- Status last verified
- Nov 2012
- First submitted
- 31 Oct 2012
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients
- ClinicalTrials.gov ID
- NCT01720082
- Acronym / sponsor ID
- AMUSING / ACOI - SICE
- Conditions
- Acute Appendicitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Associazione Chirurghi Ospedalieri ItalianiUniversity, hospital or other
- Collaborators
- Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 2 Nov 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.
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision laparoscopic appendectomy | Active comparator | Procedure: Single incision laparoscopic appendectomyAcute appendicitis with surgical indication |
| Multiport Laparoscopic appendectomy | Active comparator | Procedure: Multiport laparoscopic appendectomyAcute appendicitis with surgical indication |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age: 14-60
- American Society of Anesthesiologists (ASA) score: I-III
- absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
- diagnosis: acute appendicitis with surgical indication
Key exclusion criteria (3 listed)
- Complicated appendicitis after exploration or previously diagnosed (CT)
- Psychical inability
- Pregnancy
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 appendectomyAlso: SILAA multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end. | Procedure or surgery | Single incision laparoscopic appendectomy |
| Multiport laparoscopic appendectomyAlso: LAThree ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end. | Procedure or surgery | Multiport Laparoscopic appendectomy |
Primary outcome
Morbidity and mortality
Time frame: 30 days
6 secondary outcomes
Post-operative pain score
Time frame: 3 days
Operative time
Time frame: 1 day
Cosmetic result
Time frame: 6 months
Post-operative hospital stay
Time frame: 7 days
Incision related morbidity
Time frame: 6 months
Quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
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.
Nereo Vettoretto, MD study chair
ACOI - SICE
Ferdinando Agresta, MD study chair
ACOI - SICE
Luigi Boni, MD, FACS study chair
SICE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single incision laparoscopic appendectomy and Multiport laparoscopic appendectomy in people with Acute Appendicitis, run by Associazione Chirurghi Ospedalieri Italiani at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Nov 2012. 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 Italy. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nereo Vettoretto, MD (00393492237383, nereovet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity and mortality (time frame: 30 days). 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 Nov 2012.