An interventional study of Operative management and Drainage or antibiotics in Appendicitis, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 180 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
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Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Exclusion Criteria:
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
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
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
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.
Number of hospital days
This includes all hospital days during the initial stay and any readmission.
Time frame: Within 60 days of randomization.
Need for additional intervention for appendicitis
Percutaneous drainage, unplanned operative intervention.
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.
Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.
Time frame: Within 60 days of randomization.
Complications
Defined by National Surgical Quality Improvement Program criteria.
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
Days away from work or school.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One year after randomization.
Plan to share: No
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