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

NCT ID: NCT04168866

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2029-12-31

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.

Conditions

Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.

Group Type: EXPERIMENTAL

Operative management

Intervention Type: PROCEDURE

Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

Non-operative management

If a patient chooses non-operative management and 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.

Group Type: ACTIVE_COMPARATOR

Drainage or antibiotics

Intervention Type: OTHER

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.

Interventions

Operative management

Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kevin Schuster, MD, MPH

Role: CONTACT

kevin.schuster@yale.edu

203 785 2572

Facility Contacts

Kevin Schuster, MD

Role: primary

kevin.schuster@yale.edu

+1 (203) 785-2572

References

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.

Reference Type: BACKGROUND

PMID: 25775072 (View on PubMed)

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000026799

Identifier Type: -

Identifier Source: org_study_id