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

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ClinicalTrials.gov Identifier: NCT04168866
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Appendicitis Procedure: Operative management Other: Drainage or antibiotics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Actual Study Start Date : March 11, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Appendicitis

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.




Primary Outcome Measures :
  1. Number of hospital days [ Time Frame: Within 60 days of randomization. ]
    This includes all hospital days during the initial stay and any readmission.


Secondary Outcome Measures :
  1. Need for additional intervention for appendicitis [ Time Frame: Within one year of the index admission. ]
    Percutaneous drainage, unplanned operative intervention.

  2. Intra-abdominal abscess [ Time Frame: More than 7 days after index admission but within 60 days of randomization. ]
  3. Failed attempted procedure. [ 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.

  4. Complications [ Time Frame: Within 60 days of randomization. ]
    Defined by National Surgical Quality Improvement Program criteria.

  5. Number of interventions for abscess [ Time Frame: Within 60 days of randomization. ]
  6. Need for bowel resection. [ Time Frame: Within 60 days of randomization. ]
  7. Need for bowel resection [ Time Frame: Within 60 days of randomization. ]
  8. Occurrence of delayed appendectomy [ Time Frame: Within one year of index admission. ]
  9. Recurrence [ Time Frame: Within one year of index admission. ]
  10. Presence of malignancy in any resected specimen [ Time Frame: Within one year of index admission. ]
  11. Days of disability [ Time Frame: Within 60 days of randomization. ]
    Days away from work or school.

  12. Gastrointestinal (GI) quality of life [ 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.

  13. GI 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.

  14. GI 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168866


Contacts
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Contact: Kevin Schuster, MD, MPH 203 785 2572 kevin.schuster@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06512
Contact: Kevin Schuster, MD    203-785-2572    kevin.schuster@yale.edu   
Sponsors and Collaborators
Yale University
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04168866    
Other Study ID Numbers: 2000026799
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents