AppendicitisSILNCT00616616
Single Incision Laparoscopy
A study testing single incision laparoscopic surgery in people with Appendicitis and Cholelithiasis, run by University of California, San Diego at 1 site in United States.
Trial summary
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Appendicitis, Cholelithiasis, Malignant Hypertension
- What is being tested?
- single incision laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Feb 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75
- Patient has consented for a laparoscopic operation (independent of study participation)
- Attending surgeon decides operation can be completed via a single incision laparoscopic approach
Who cannot join
- Patients with BMI greater than 40
- Minors and cognitively impaired individuals
- Patients who are ASA class IV - Illness that is a constant threat to life
- Patients with ascites or Child's class C of liver failure
- Patients with known common bile duct stones
- Patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation.
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- Patients who present with incarcerated (irreducible) or strangulated hernias
- Patients with preoperative hematocrits less than 25.
- Preoperative hematocrit less than 25.
- Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
- Heart rate greater than 130 or less than 50. Respiratory rate greater than 35 or less than 6. Patients who are on continuous pressor drip for blood pressure support.
- Patients who present for emergency adrenalectomy.
- Patients with CT scan evidence of an abdominal abscess.
- Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).
- Conditions
- Appendicitis, Cholelithiasis, Malignant Hypertension
- Being tested
- single incision laparoscopic surgery
- Keywords
- appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement
- Medical subject headings
- Appendicitis, Cholelithiasis, Hypertension, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single incision laparoscopic surgeryProcedure or surgery
Surgery will be performed with ine laparoscopic incision
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | all subjects Receives: Procedure: single incision laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and efficacy of single incision laparoscopy
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 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionJul 2009
- Study completionFeb 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Horgan, University of California, San Diego
- Investigators
- Santiago Horgan, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616616
- Sponsor's protocol ID
- 071271
- Acronym
- SIL
- Status last verified
- Oct 2016
- First submitted
- 4 Feb 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Laparoscopy
- ClinicalTrials.gov ID
- NCT00616616
- Acronym / sponsor ID
- SIL / 071271
- Conditions
- Appendicitis, Cholelithiasis, Malignant Hypertension
- Keywords
- appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Feb 2008 (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 surgery being performed with only one small incision via the umbilicus (belly button).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: single incision laparoscopic surgeryall subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-75
- Patient has consented for a laparoscopic operation (independent of study participation)
- Attending surgeon decides operation can be completed via a single incision laparoscopic approach
Key exclusion criteria (14 listed)
- Patients with BMI greater than 40
- Minors and cognitively impaired individuals
- Patients who are ASA class IV - Illness that is a constant threat to life
- Patients with ascites or Child's class C of liver failure
- Patients with known common bile duct stones
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 surgerySurgery will be performed with ine laparoscopic incision | Procedure or surgery | 1 |
Primary outcome
Evaluate the safety and efficacy of single incision laparoscopy
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 Oct 2016.
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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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.
Santiago Horgan, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single incision laparoscopic surgery in people with Appendicitis and Cholelithiasis, run by University of California, San Diego at 1 site in United States.
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 3 inclusion and 14 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 Oct 2016. 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 United States. 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?
Evaluate the safety and efficacy of single incision laparoscopy (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 Oct 2016; AzTrials last refreshed its copy on 26 Oct 2026.