Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Operative management, Drainage or antibiotics.
- Who it may be relevant to
- Registry conditions: Appendicitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Operative management
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess. - 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.
Primary outcome measures
- Number of hospital days [Time frame: Within 60 days of randomization.]
Secondary outcome measures (12)
- Need for additional intervention for appendicitis [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. [Time frame: Within 60 days of randomization.]
- Complications [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 [Time frame: Within 60 days of randomization.]
- Gastrointestinal (GI) quality of life [Time frame: 30 days after randomization.]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale New Haven Hospital — New Haven
Publications
- 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. PMID 25775072
Identifiers
NCT: NCT04168866 · 2000026799 · No NIH funding