Clinical trial NCT04168866: Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Official title: Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of hospital days
timeFrame: Within 60 days of randomization.
Secondary outcomes:
measure: Need for additional intervention for appendicitis
timeFrame: Within one year of the index admission.
measure: Intra-abdominal abscess
timeFrame: More than 7 days after index admission but within 60 days of randomization.
measure: Failed attempted procedure.
timeFrame: Within 60 days of randomization.
measure: Complications
timeFrame: Within 60 days of randomization.
measure: Number of interventions for abscess
timeFrame: Within 60 days of randomization.
measure: Need for bowel resection.
timeFrame: Within 60 days of randomization.
measure: Need for bowel resection
timeFrame: Within 60 days of randomization.
measure: Occurrence of delayed appendectomy
timeFrame: Within one year of index admission.
measure: Recurrence
timeFrame: Within one year of index admission.
measure: Presence of malignancy in any resected specimen
timeFrame: Within one year of index admission.
measure: Days of disability
timeFrame: Within 60 days of randomization.
measure: Gastrointestinal (GI) quality of life
timeFrame: 30 days after randomization.
measure: GI quality of life
timeFrame: 60 days after randomization.
measure: GI quality of life
timeFrame: One year after randomization.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
citation: 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.