Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

August 22, 2025 updated by: Yale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • Recruiting
        • Yale New Haven Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).

Exclusion Criteria:

  1. Antibiotic therapy greater than 24 hours prior to considering for enrollment.
  2. Attempted drainage before randomization
  3. Pregnancy
  4. Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
  5. Previous major intra-abdominal surgery by laparotomy
  6. Hospitalization within 2 weeks of randomization
  7. Presence of septic shock on admission.
  8. Mechanical ventilation
  9. Acute renal failure requiring dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Surgery
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.
Procedure: Operative management
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Active Comparator: Non-operative management
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.
Other: Drainage or antibiotics
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of hospital days
Time Frame: Within 60 days of randomization.
This includes all hospital days during the initial stay and any readmission.
Within 60 days of randomization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for additional intervention for appendicitis
Time Frame: Within one year of the index admission.
Percutaneous drainage, unplanned operative intervention.
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.
More than 7 days after index admission but within 60 days of randomization.
Failed attempted procedure.
Time Frame: Within 60 days of randomization.
Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.
Within 60 days of randomization.
Complications
Time Frame: Within 60 days of randomization.
Defined by National Surgical Quality Improvement Program criteria.
Within 60 days of randomization.
Number of interventions for abscess
Time Frame: Within 60 days of randomization.
Within 60 days of randomization.
Need for bowel resection.
Time Frame: Within 60 days of randomization.
Within 60 days of randomization.
Need for bowel resection
Time Frame: Within 60 days of randomization.
Within 60 days of randomization.
Occurrence of delayed appendectomy
Time Frame: Within one year of index admission.
Within one year of index admission.
Recurrence
Time Frame: Within one year of index admission.
Within one year of index admission.
Presence of malignancy in any resected specimen
Time Frame: Within one year of index admission.
Within one year of index admission.
Days of disability
Time Frame: Within 60 days of randomization.
Days away from work or school.
Within 60 days of randomization.
Gastrointestinal (GI) quality of life
Time Frame: 30 days after randomization.
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.
30 days after randomization.
GI quality of life
Time Frame: 60 days after randomization.
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.
60 days after randomization.
GI quality of life
Time Frame: One year after randomization.
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.
One year after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000026799
  • No NIH funding (Other Identifier: 10.20.23)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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