Acute AppendicitisNCT01424631
Single Incision Versus Conventional Laparoscopic Appendectomy
A study testing single incision laparoscopic appendectomy and conventional laparoscopic appendectomy in people with Acute Appendicitis, run by Mansoura University.
Trial summary
This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- single incision laparoscopic appendectomy and conventional laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 10 to 80 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- acute appendicitis
Who cannot join
- perforation with peritonitis
- lower abdominal scar
- contraindications to laparoscopy
About this study
This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.
- Conditions
- Acute Appendicitis
- Being tested
- single incision laparoscopic appendectomy, conventional 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
conventional laparoscopic appendectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| single incision laparoscopic appendectomy | Active comparator | Not described Receives: Procedure: single incision laparoscopic appendectomy |
| conventional laparoscopic appendectomy | Placebo comparator | Not described Receives: Procedure: conventional laparoscopic appendectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel-Raouf El-Geidie, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424631
- Sponsor's protocol ID
- lap appendectomy 123
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Versus Conventional Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT01424631
- Acronym / sponsor ID
- lap appendectomy 123
- Conditions
- Acute Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- First posted
- 29 Aug 2011 (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.
This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.
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 appendectomy |
| conventional laparoscopic appendectomy | Placebo comparator | Procedure: conventional laparoscopic appendectomy |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- acute appendicitis
Key exclusion criteria (3 listed)
- perforation with peritonitis
- lower abdominal scar
- contraindications to laparoscopy
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 laparoscopic appendectomy | Procedure or surgery | conventional laparoscopic 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 29 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing single incision laparoscopic appendectomy and conventional laparoscopic appendectomy in people with Acute Appendicitis, run by Mansoura University.
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 29 Aug 2011. 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. Some participants in this study may receive a placebo. 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.
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 29 Aug 2011.