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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-iodine irrigation | Experimental |
| |
| No irrigation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-iodine irrigation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post surgery |
| Number of Participants Who Were Readmitted to the Hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KuoJen Tsao, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567357 | Derived | 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. |
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Of 372 subjects consented, 100 were enrolled as these subjects had perforated appendicities
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| ID | Title | Description |
|---|---|---|
| FG000 | Povidone-iodine Irrigation | Povidone-iodine irrigation: 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. |
| FG001 | No Irrigation | No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-iodine Irrigation | Povidone-iodine irrigation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 30 days post surgery |
|
30 days post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-iodine Irrigation | Povidone-iodine irrigation: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kuojen Tsao | McGovern Medical School, University of Texas Health Sciences Center at Houston | 713-500-7300 | Kuojen.Tsao@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2016 | Mar 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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|
| No irrigation | Procedure | Patients allocated to the control group will not undergo intra-abdominal irrigation. |
|
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. |
| 30 days post surgery |
| 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. | 30 days post surgery |
| BG001 | No Irrigation | No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | No Irrigation | No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | 30 days post surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days post surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days post surgery |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | No Irrigation | No irrigation: Patients allocated to the control group will not undergo intra-abdominal irrigation. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |