Acute AppendicitisNCT01002365
Perioperative Hyperoxygenation and Wound Site Infection Following Surgery for Acute Appendicitis
A study testing Oxygen delivery and Oxygen administration in people with Acute Appendicitis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Oxygen delivery and Oxygen administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Consent was given
- 15 years old or older
- Underwent acute appendicitis
Who cannot join
- Lack of follow up
- Younger than 15 years
- Not eligible according to physician decision
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.
- Conditions
- Acute Appendicitis
- Being tested
- Oxygen delivery, Oxygen administration
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen deliveryOther
Oxygen administrationOther
| Study group | Role | What they receive |
|---|---|---|
| Post op care | Active comparator | Not described Receives: Other: Oxygen delivery; Other: Oxygen administration |
| Oxygen administration- different % | Active comparator | Not described Receives: Other: Oxygen administration |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
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 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
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002365
- Sponsor's protocol ID
- Bickel10-2009
- Status last verified
- Oct 2009
- First submitted
- 25 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bickel A, Gurevits M, Vamos R, Ivry S, Eitan A. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial. Arch Surg. 2011 Apr;146(4):464-70. doi: 10.1001/archsurg.2011.65.
PubMed 21502457
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hyperoxygenation and Wound Site Infection Following Surgery for Acute Appendicitis
- ClinicalTrials.gov ID
- NCT01002365
- Acronym / sponsor ID
- Bickel10-2009
- Conditions
- Acute Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- First posted
- 27 Oct 2009 (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.
Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post op care | Active comparator | Other: Oxygen delivery, Other: Oxygen administration |
| Oxygen administration- different % | Active comparator | Other: Oxygen administration |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Consent was given
- 15 years old or older
- Underwent acute appendicitis
Key exclusion criteria (3 listed)
- Lack of follow up
- Younger than 15 years
- Not eligible according to physician decision
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 |
|---|---|---|
| Oxygen delivery | Other | Post op care |
| Oxygen administration | Other | Oxygen administration- different %, Post op care |
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 27 Oct 2009.
- Derived from this study: PubMed 21502457Bickel A, Gurevits M, Vamos R, Ivry S, Eitan A. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial. Arch Surg. 2011 Apr;146(4):464-70. doi: 10.1001/archsurg.2011.65.
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
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen delivery and Oxygen administration in people with Acute Appendicitis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 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 27 Oct 2009. 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 Israel. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002365, 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 27 Oct 2009.