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

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.

Study Overview

• Status: Recruiting
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: Operative management; Other: Drainage or antibiotics

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Schuster, MD, MPH; Phone Number: 203 785 2572; Email: kevin.schuster@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06512
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Kevin Schuster, MD; Phone Number: 203-785-2572; Email: kevin.schuster@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Operative management; Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital days	This includes all hospital days during the initial stay and any readmission.	Within 60 days of randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for additional intervention for appendicitis	Percutaneous drainage, unplanned operative intervention.	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.	Conversion from laparoscopic to open surgery, conversion from non-operative to operative management, percutaneous drainage not possible or unsuccessful.	Within 60 days of randomization.
Complications	Defined by National Surgical Quality Improvement Program criteria.	Within 60 days of randomization.
Number of interventions for abscess		Within 60 days of randomization.
Need for bowel resection.		Within 60 days of randomization.
Need for bowel resection		Within 60 days of randomization.
Occurrence of delayed appendectomy		Within one year of index admission.
Recurrence		Within one year of index admission.
Presence of malignancy in any resected specimen		Within one year of index admission.
Days of disability	Days away from work or school.	Within 60 days of randomization.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Yale University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2000026799; No NIH funding (Other Identifier: 01.22.24)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No