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NCT Number: NCT04168866

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location status: Recruiting

Location contact

Kevin Schuster, MD

CONTACT

[email protected]

+1 (203) 785-2572

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Presence of septic shock on admission.
  • Mechanical ventilation
  • Acute renal failure requiring dialysis

Treatment and study plan

Operative management

Procedure

Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

Drainage or antibiotics

Other

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.

Primary outcomes

  1. Number of hospital days

    Time frame: Within 60 days of randomization.

    This includes all hospital days during the initial stay and any readmission.

Secondary outcomes

  1. Need for additional intervention for appendicitis

    Time frame: Within one year of the index admission.

    Percutaneous drainage, unplanned operative intervention.

  2. Intra-abdominal abscess

    Time frame: More than 7 days after index admission but within 60 days of randomization.

  3. 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.

  4. Complications

    Time frame: Within 60 days of randomization.

    Defined by National Surgical Quality Improvement Program criteria.

  5. Number of interventions for abscess

    Time frame: Within 60 days of randomization.

  6. Need for bowel resection.

    Time frame: Within 60 days of randomization.

  7. Need for bowel resection

    Time frame: Within 60 days of randomization.

  8. Occurrence of delayed appendectomy

    Time frame: Within one year of index admission.

  9. Recurrence

    Time frame: Within one year of index admission.

  10. Presence of malignancy in any resected specimen

    Time frame: Within one year of index admission.

  11. Days of disability

    Time frame: Within 60 days of randomization.

    Days away from work or school.

  12. 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.

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Schuster, MD, MPH

CONTACT

[email protected]

203 785 2572

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Nov 19, 2019
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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