Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

Appendicitis Clinical Trial

Official title:

Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168866
• Other study ID #: 2000026799
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Kevin Schuster, MD, MPH
• Phone: 203 785 2572
• Email: kevin.schuster[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospital days	This includes all hospital days during the initial stay and any readmission.	Within 60 days of randomization.
Secondary	Need for additional intervention for appendicitis	Percutaneous drainage, unplanned operative intervention.	Within one year of the index admission.
Secondary	Intra-abdominal abscess		More than 7 days after index admission but within 60 days of randomization.
Secondary	Failed attempted procedure.	Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.	Within 60 days of randomization.
Secondary	Complications	Defined by National Surgical Quality Improvement Program criteria.	Within 60 days of randomization.
Secondary	Number of interventions for abscess		Within 60 days of randomization.
Secondary	Need for bowel resection.		Within 60 days of randomization.
Secondary	Need for bowel resection		Within 60 days of randomization.
Secondary	Occurrence of delayed appendectomy		Within one year of index admission.
Secondary	Recurrence		Within one year of index admission.
Secondary	Presence of malignancy in any resected specimen		Within one year of index admission.
Secondary	Days of disability	Days away from work or school.	Within 60 days of randomization.
Secondary	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.	30 days after randomization.
Secondary	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.	60 days after randomization.
Secondary	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.	One year after randomization.