Yale New Haven Hospital
New Haven, Connecticut, 06512, United States
Location status: Recruiting
NCT Number: NCT04168866
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06512, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 60 days of randomization.
This includes all hospital days during the initial stay and any readmission.
Time frame: Within one year of the index admission.
Percutaneous drainage, unplanned operative intervention.
Time frame: More than 7 days after index admission but within 60 days of randomization.
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.
Time frame: Within 60 days of randomization.
Defined by National Surgical Quality Improvement Program criteria.
Time frame: Within 60 days of randomization.
Time frame: Within 60 days of randomization.
Time frame: Within 60 days of randomization.
Time frame: Within one year of index admission.
Time frame: Within one year of index admission.
Time frame: Within one year of index admission.
Time frame: Within 60 days of randomization.
Days away from work or school.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Yale University
Other
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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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