NCT04168866

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2020Dec 2029

First Submitted

Initial submission to the registry

November 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

8.8 years

First QC Date

November 16, 2019

Last Update Submit

August 22, 2025

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Number of hospital days

    This includes all hospital days during the initial stay and any readmission.

    Within 60 days of randomization.

Secondary Outcomes (14)

  • Need for additional intervention for appendicitis

    Within one year of the index admission.

  • Intra-abdominal abscess

    More than 7 days after index admission but within 60 days of randomization.

  • Failed attempted procedure.

    Within 60 days of randomization.

  • Complications

    Within 60 days of randomization.

  • Number of interventions for abscess

    Within 60 days of randomization.

  • +9 more secondary outcomes

Study Arms (2)

Surgery

EXPERIMENTAL

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.

Procedure: Operative management

Non-operative management

ACTIVE COMPARATOR

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.

Other: Drainage or antibiotics

Interventions

Operative managementPROCEDURE

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

Surgery
Drainage or antibioticsOTHER

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.

Non-operative management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

RECRUITING

Related 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.

    PMID: 25775072BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

DrainageAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, OperativeAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Kevin Schuster, MD, MPH

CONTACT

203 785 2572kevin.schuster@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 19, 2019

Study Start

March 11, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)