Head-Only vs Full-Body Draping for Tonsillectomy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different draping techniques during pediatric tonsillectomy affect post-surgery infection rates. It compares head-only draping with traditional full-body draping. The study also examines waste production, costs, and doctors' preferences for the two methods. Children under 18 undergoing tonsil removal, with or without adenoids, can participate if they have no other health issues requiring full-body draping. As an unphased trial, this study provides a unique opportunity to enhance surgical practices and outcomes for children.
What prior data suggests that these draping techniques are safe for pediatric tonsillectomy?
Research shows that tonsillectomy is generally safe for children. Studies have found that intracapsular coblation tonsillectomy, a common method, has fewer complications. This surgery is usually well-tolerated, regardless of how the patient is draped during the procedure.
Limited research compares head-only draping to full-body draping for tonsillectomy. However, this study examines how these draping methods might affect infection rates, not the surgery itself. The main concern is whether one method leads to more infections, not whether they introduce new risks.
Using either head-only or full-body draping should not create additional safety issues. The study will closely monitor any differences in infection rates after surgery. Overall, tonsillectomy is a common and safe procedure, with standard precautions in place to protect patients.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores whether head-only draping during pediatric tonsillectomies could offer benefits over the traditional full-body draping. Unlike the full-body draping method, which covers the entire patient, head-only draping is less extensive and might make the procedure quicker and more comfortable for both patients and surgeons. By potentially reducing preparation time and improving surgical workflow, this technique could enhance the overall efficiency of tonsillectomies. Additionally, it might minimize the risk of overheating and discomfort for patients, which is an important consideration in pediatric surgeries.
What evidence suggests that this trial's draping techniques could be effective for reducing postoperative infection rates in pediatric tonsillectomy?
This trial will compare head-only draping with full-body draping during pediatric tonsillectomy. Research has not directly compared these draping methods for infection rates in children's tonsil removal surgeries. However, the safety and outcomes of tonsil removal surgery are well understood. One study found that intracapsular coblation, which uses radio waves to remove tonsils, was safe and caused no postoperative problems in a group of 100 patients. This finding suggests that the surgical method might influence outcomes more than the draping method. Since this trial examines head-only versus full-body draping, it will provide crucial insights, as previous research has not specifically addressed this comparison.13678
Who Is on the Research Team?
Neelima Tummala, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for pediatric patients under 18 years old who are scheduled for a tonsillectomy, possibly with adenoidectomy but no other procedures. They must be able to complete a follow-up after 30 days and have parental permission.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pediatric tonsillectomy with either head-only or full-body draping
Follow-up
Participants are monitored for 30-day postoperative infection rates and secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Full-Body Draping
- Head-Only Draping
Trial Overview
The study compares infection rates following pediatric tonsillectomy using two different surgical draping methods: head-only versus full-body. It also assesses waste production, costs, and provider attitudes towards each method.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Pediatric tonsillectomy will be performed with head-only draping.
Pediatric tonsillectomy will be performed with traditional full-body draping.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
An observational pragmatic quality-of-life study on ...
Paediatric tonsillectomy improves quality of life with a sustained benefit in the long term. There is no improvement to the patient's quality of ...
A scoping review of randomized clinical trials for pain ...
This novel scoping review highlights the heterogeneity of research in pediatric posttonsillectomy pain management.
Short-Term Outcomes of Tonsillectomy in Large Paediatric ...
Conclusions. Intracapsular coblation tonsillectomy has been shown to be a safe and effective procedure with fewer complications. Our findings ...
4.
deepblue.lib.umich.edu
deepblue.lib.umich.edu/bitstream/handle/2027.42/166212/lary28739_am.pdf?sequence=1Validation of an Objective Assessment Tool for Tonsillectomy ...
Procedure time, patient age performed tonsillectomies, and surgical technique were also collected. Results: One-hundred-sixty-seven tonsil OSATS were completed ...
Coblation intracapsular tonsillectomy in pediatric patients
A study of 100 consecutive patients out of London reported zero postoperative complications including no cases of postoperative hemorrhage.4 At our institution, ...
Review Article Update on the safety of anesthesia in young ...
The purpose of this article is to review the safety of general anesthesia for adenotonsillectomy with a focus on those issues related to young children.
7.
researchgate.net
researchgate.net/publication/351989382_Update_on_the_safety_of_anesthesia_in_young_children_presenting_for_adenotonsillectomy(PDF) Update on the safety of anesthesia in young children ...
Tonsillectomy with and without adenoidectomy is a frequently performed surgical procedure in children. Although a common procedure, ...
Tonsillectomy in Children: Update to Guidelines for ...
Clinicians should recommend ibuprofen, acetaminophen, or both for pain control after tonsillectomy.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.