Appendicitis AcuteNCT06948071
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
A study testing Discharge on oral antibiotics in people with Appendicitis Acute and Appendicitis Perforated, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis Acute, Appendicitis Perforated, Appendicitis With Perforation
- What is being tested?
- Discharge on oral antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals between the ages of 18 and 65 years of age.
- Patients undergoing a laparoscopic appendectomy.
- Diagnosis of complicated appendicitis based on pre-operative imaging or intra-operative assessment. The definition of a complicated appendicitis will include: (a) perforated appendicitis, without generalized peritonitis; (b) gangrenous appendicitis, without generalized peritonitis; (c) suppurative appendicitis; (d) iatrogenic perforation of the appendix.
- Meet criteria for discharge from the post-anesthesia care unit (PACU).
- Ability to reliably follow up with the study procedures.
Who cannot join
- Age < 18 years or > 65 years.
- Pregnancy.
- Homelessness.
- Patients who present with generalized peritonitis.
- Patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding Aspirin 81 mg).
- Patients who present with septic shock.
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- Patients who require conversion to an open appendectomy.
- Patients who present with additional findings on imaging studies or intra-operatively, including ileus or small bowel obstruction.
- Based on surgeon's clinical judgment for reasons that may not be outlined above.
- Allergy or intolerance to study medication(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Laura Sarmiento, CCRP
Galinos Barmparas, MD
About this study
Official title: Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study
The exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis. Feasibility will be determined by high compliance and adherence of patients to the postoperative instructions, while safety will be assessed by the incidence of postoperative infectious complications and requirement for re-admission.
- Conditions
- Appendicitis Acute, Appendicitis Perforated, Appendicitis With Perforation, Appendicitis Suppurative, Appendicitis Gangrenous
- Being tested
- Discharge on oral antibiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge on oral antibioticsOther
Patients will be discharged to home on an oral antibiotic regimen for 3 days instead of being admitted for intravenous antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Other | Patients with intraoperative diagnosis of complicated appendicitis as determined by the operating surgeon. Receives: Other: Discharge on oral antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate
Feasibility will be determined by the readmission within 30 days rate for any reason
Measured: 30 days
Postoperative infections
Safety will be assessed by the incidence of postoperative infectious complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galinos Barmparas, MD, Cedars-Sinai Medical Center
- Investigators
- Galinos Barmparas, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948071
- Sponsor's protocol ID
- STUDY00003804
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Rossem CC, Schreinemacher MH, van Geloven AA, Bemelman WA; Snapshot Appendicitis Collaborative Study Group. Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. JAMA Surg. 2016 Apr;151(4):323-9. doi: 10.1001/jamasurg.2015.4236.
PubMed 26580850van den Boom AL, de Wijkerslooth EML, Giesen LJX, van Rossem CC, Toorenvliet BR, Wijnhoven BPL. Postoperative Antibiotics and Time to Reach Discharge Criteria after Appendectomy for Complex Appendicitis. Dig Surg. 2022;39(4):162-168. doi: 10.1159/000526790. Epub 2022 Aug 30.
PubMed 36041400Kleif J, Rasmussen L, Fonnes S, Tibaek P, Daoud A, Lund H, Gogenur I. Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study. World J Surg. 2017 Nov;41(11):2706-2714. doi: 10.1007/s00268-017-4076-6.
PubMed 28600695
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06948071
- Acronym / sponsor ID
- STUDY00003804
- Conditions
- Appendicitis Acute, Appendicitis Perforated, Appendicitis With Perforation, Appendicitis Suppurative, Appendicitis Gangrenous
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- 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 exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis. Feasibility will be determined by high compliance and adherence of patients to the postoperative instructions, while safety will be assessed by the incidence of postoperative infectious complications and requirement for re-admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAS | Other | Other: Discharge on oral antibioticsPatients with intraoperative diagnosis of complicated appendicitis as determined by the operating surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals between the ages of 18 and 65 years of age.
- Patients undergoing a laparoscopic appendectomy.
- Diagnosis of complicated appendicitis based on pre-operative imaging or intra-operative assessment. The definition of a complicated appendicitis will include: (a) perforated appendicitis, without generalized peritonitis; (b) gangrenous appendicitis, without generalized peritonitis; (c) suppurative appendicitis; (d) iatrogenic perforation of the appendix.
- Meet criteria for discharge from the post-anesthesia care unit (PACU).
- Ability to reliably follow up with the study procedures.
Key exclusion criteria (10 listed)
- Age < 18 years or > 65 years.
- Pregnancy.
- Homelessness.
- Patients who present with generalized peritonitis.
- Patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding Aspirin 81 mg).
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 |
|---|---|---|
| Discharge on oral antibioticsPatients will be discharged to home on an oral antibiotic regimen for 3 days instead of being admitted for intravenous antibiotics. | Other | ERAS |
Primary outcome
Readmission rate
Time frame: 30 days
Feasibility will be determined by the readmission within 30 days rate for any reason
Postoperative infections
Time frame: 30 days
Safety will be assessed by the incidence of postoperative infectious complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 26580850van Rossem CC, Schreinemacher MH, van Geloven AA, Bemelman WA; Snapshot Appendicitis Collaborative Study Group. Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. JAMA Surg. 2016 Apr;151(4):323-9. doi: 10.1001/jamasurg.2015.4236.
- Background: PubMed 36041400van den Boom AL, de Wijkerslooth EML, Giesen LJX, van Rossem CC, Toorenvliet BR, Wijnhoven BPL. Postoperative Antibiotics and Time to Reach Discharge Criteria after Appendectomy for Complex Appendicitis. Dig Surg. 2022;39(4):162-168. doi: 10.1159/000526790. Epub 2022 Aug 30.
- Background: PubMed 28600695Kleif J, Rasmussen L, Fonnes S, Tibaek P, Daoud A, Lund H, Gogenur I. Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study. World J Surg. 2017 Nov;41(11):2706-2714. doi: 10.1007/s00268-017-4076-6.
- Postoperative antibiotic therapy after appendectomy in patients with non-perforated appendicitis - PMC.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Galinos Barmparas, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge on oral antibiotics in people with Appendicitis Acute and Appendicitis Perforated, run by Cedars-Sinai Medical Center 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sarmiento, CCRP (310-423-4295, laura.sarmiento@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission rate (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06948071, which also lists 3 linked publications.
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 Apr 2025.