Back to resultsDilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Primary Purpose
Acute, Perforated Appendicitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Povidone-iodine irrigation
No irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Acute, Perforated Appendicitis focused on measuring Povidone-iodine irrigation
Eligibility Criteria
Inclusion Criteria:
- Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)
Exclusion Criteria:
- Patients presenting with simple or gangrenous appendicitis
- Patients with a history of iodine sensitivity, thyroid disease or renal disease
- Patients undergoing interval or incidental appendectomy
- Patients/parents/legal guardians who are both non-English and non-Spanish speaking
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Povidone-iodine irrigation
No irrigation
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Postoperative Intra-abdominal Abscess
30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Secondary Outcome Measures
Total Hospital Length of Stay
Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
Number of Participants Who Were Readmitted to the Hospital
Whether or not a patient was readmitted to the hospital within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
Number of Participants Who Visited the Emergency Room
Whether or not a patient visited the emergency room for care directly related to the operation within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
Full Information
NCT ID
NCT02664220
First Posted
December 21, 2015
Last Updated
March 27, 2019
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02664220
Brief Title
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Official Title
A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.
Detailed Description
Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. This trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute, Perforated Appendicitis
Keywords
Povidone-iodine irrigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Povidone-iodine irrigation
Arm Type
Experimental
Arm Title
No irrigation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine irrigation
Intervention Description
Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.
Intervention Type
Procedure
Intervention Name(s)
No irrigation
Intervention Description
Patients allocated to the control group will not undergo intra-abdominal irrigation.
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Intra-abdominal Abscess
Description
30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
Total Hospital Length of Stay
Description
Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.
Time Frame
30 days post surgery
Title
Number of Participants Who Were Readmitted to the Hospital
Description
Whether or not a patient was readmitted to the hospital within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
Time Frame
30 days post surgery
Title
Number of Participants Who Visited the Emergency Room
Description
Whether or not a patient visited the emergency room for care directly related to the operation within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)
Exclusion Criteria:
Patients presenting with simple or gangrenous appendicitis
Patients with a history of iodine sensitivity, thyroid disease or renal disease
Patients undergoing interval or incidental appendectomy
Patients/parents/legal guardians who are both non-English and non-Spanish speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KuoJen Tsao, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31567357
Citation
Anderson KT, Putnam LR, Bartz-Kurycki MA, Hamilton EC, Yafi M, Pedroza C, Austin MT, Kawaguchi AL, Kao LS, Lally KP, Tsao K. Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial. Ann Surg. 2020 May;271(5):827-833. doi: 10.1097/SLA.0000000000003398.
Results Reference
derived
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Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
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