AppendicitisNCT04168866
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
A study testing Operative management and Drainage or antibiotics in people with Appendicitis, run by Yale University at 1 site in United States.
Trial summary
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Operative management and Drainage or antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 31 Dec 2029
- 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
- 1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Who cannot join
- Antibiotic therapy greater than 24 hours prior to considering for enrollment.
- Attempted drainage before randomization
- Pregnancy
- Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
- Previous major intra-abdominal surgery by laparotomy
- Hospitalization within 2 weeks of randomization
Show all 9Show fewer
- Presence of septic shock on admission.
- Mechanical ventilation
- Acute renal failure requiring dialysis
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
Yale New Haven Hospital
New Haven, Connecticut, 06512
Kevin Schuster, MD, +1 (203) 785-2572, kevin.schuster@yale.edu
About this study
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Read the detailed description
Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.
- Conditions
- Appendicitis
- Being tested
- Operative management, Drainage or antibiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative managementProcedure or surgery
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Drainage or antibioticsOther
If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures. Receives: Procedure: Operative management |
| Non-operative management | Active comparator | If a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided. Receives: Other: Drainage or antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital days
This includes all hospital days during the initial stay and any readmission.
Measured: Within 60 days of randomization.
Secondary outcomes (14)
Need for additional intervention for appendicitis
Percutaneous drainage, unplanned operative intervention.
Measured: Within one year of the index admission.
Intra-abdominal abscess
Measured: More than 7 days after index admission but within 60 days of randomization.
Failed attempted procedure.
Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.
Measured: Within 60 days of randomization.
Complications
Defined by National Surgical Quality Improvement Program criteria.
Measured: Within 60 days of randomization.
Number of interventions for abscess
Measured: Within 60 days of randomization.
Need for bowel resection.
Measured: Within 60 days of randomization.
Need for bowel resection
Measured: Within 60 days of randomization.
Occurrence of delayed appendectomy
Measured: Within one year of index admission.
Recurrence
Measured: Within one year of index admission.
Presence of malignancy in any resected specimen
Measured: Within one year of index admission.
Days of disability
Days away from work or school.
Measured: Within 60 days of randomization.
Gastrointestinal (GI) quality of life
This outcome will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale. This scale includes 8 subscales of which the investigators will use 6 for a maximum of 41 items, though usually less due to skip logic. Each item is measured on a 5-point scale. Items are summed by subscale and converted to a final score by a computer algorithm. A higher score indicates greater symptom severity and lower quality of life.
Measured: 30 days after randomization.
GI quality of life
This outcome will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale. This scale includes 8 subscales of which the investigators will use 6 for a maximum of 41 items, though usually less due to skip logic. Each item is measured on a 5-point scale. Items are summed by subscale and converted to a final score by a computer algorithm. A higher score indicates greater symptom severity and lower quality of life.
Measured: 60 days after randomization.
GI quality of life
This outcome will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale. This scale includes 8 subscales of which the investigators will use 6 for a maximum of 41 items, though usually less due to skip logic. Each item is measured on a 5-point scale. Items are summed by subscale and converted to a final score by a computer algorithm. A higher score indicates greater symptom severity and lower quality of life.
Measured: One year after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start11 Mar 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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 AppendicitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168866
- Sponsor's protocol ID
- 2000026799
- Other IDs
- No NIH funding
- Status last verified
- Aug 2025
- First submitted
- 16 Nov 2019
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mentula P, Sammalkorpi H, Leppaniemi A. Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial. Ann Surg. 2015 Aug;262(2):237-42. doi: 10.1097/SLA.0000000000001200.
PubMed 25775072
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
- ClinicalTrials.gov ID
- NCT04168866
- Acronym / sponsor ID
- 2000026799
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Nov 2019 (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 investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Detailed description
Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Operative managementPatients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures. |
| Non-operative management | Active comparator | Other: Drainage or antibioticsIf a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Key exclusion criteria (9 listed)
- Antibiotic therapy greater than 24 hours prior to considering for enrollment.
- Attempted drainage before randomization
- Pregnancy
- Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
- Previous major intra-abdominal surgery by laparotomy
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 |
|---|---|---|
| Operative managementSurgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess. | Procedure or surgery | Surgery |
| Drainage or antibioticsIf an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided. | Other | Non-operative management |
Primary outcome
Number of hospital days
Time frame: Within 60 days of randomization.
This includes all hospital days during the initial stay and any readmission.
14 secondary outcomes
Need for additional intervention for appendicitis
Time frame: Within one year of the index admission.
Intra-abdominal abscess
Time frame: More than 7 days after index admission but within 60 days of randomization.
Failed attempted procedure.
Time frame: Within 60 days of randomization.
Complications
Time frame: Within 60 days of randomization.
Number of interventions for abscess
Time frame: Within 60 days of randomization.
Need for bowel resection.
Time frame: Within 60 days of randomization.
Need for bowel resection
Time frame: Within 60 days of randomization.
Occurrence of delayed appendectomy
Time frame: Within one year of index admission.
Recurrence
Time frame: Within one year of index admission.
Presence of malignancy in any resected specimen
Time frame: Within one year of index admission.
Days of disability
Time frame: Within 60 days of randomization.
Gastrointestinal (GI) quality of life
Time frame: 30 days after randomization.
GI quality of life
Time frame: 60 days after randomization.
GI quality of life
Time frame: One year after randomization.
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 Aug 2025.
- Background: PubMed 25775072Mentula P, Sammalkorpi H, Leppaniemi A. Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial. Ann Surg. 2015 Aug;262(2):237-42. doi: 10.1097/SLA.0000000000001200.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative management and Drainage or antibiotics in people with Appendicitis, run by Yale University 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 1 inclusion and 9 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 Aug 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 Kevin Schuster, MD, MPH (203 785 2572, kevin.schuster@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital days (time frame: Within 60 days of randomization.). 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 NCT04168866, 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 29 Aug 2025.