Appendicitis
Conditions
Brief 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.
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.
Interventions
PROCEDUREOperative management
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
OTHERDrainage 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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital days | Within 60 days of randomization. | This includes all hospital days during the initial stay and any readmission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-abdominal abscess | More than 7 days after index admission but within 60 days of randomization. | — |
| Failed attempted procedure. | Within 60 days of randomization. | Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful. |
| Complications | Within 60 days of randomization. | Defined by National Surgical Quality Improvement Program criteria. |
| Number of interventions for abscess | Within 60 days of randomization. | — |
| Need for bowel resection. | Within 60 days of randomization. | — |
| Need for bowel resection | Within 60 days of randomization. | — |
| Need for additional intervention for appendicitis | Within one year of the index admission. | Percutaneous drainage, unplanned operative intervention. |
| Recurrence | Within one year of index admission. | — |
| Presence of malignancy in any resected specimen | Within one year of index admission. | — |
| Days of disability | Within 60 days of randomization. | Days away from work or school. |
| Gastrointestinal (GI) quality of life | 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. |
| GI quality of life | 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. |
| Occurrence of delayed appendectomy | Within one year of index admission. | — |
Countries
United States
Contacts
Primary ContactKevin Schuster, MD, MPH
Outcome results
None listed