Closure Method Study Following Tonsillectomy in Children

NCT00730340 | Completed Early Phase 1

• 1 other identifier: Tonsillar Closure_Berryhill
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

Conditions

Tonsillectomy; Children

Keywords

Tonsillectomy, tonsillar fossa, wound closure

Outcome Measures

Primary Outcomes (1)

• Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure

  6 months

Secondary Outcomes (1)

• The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.

  10-14 days postoperatively

Study Arms (2)

1

ACTIVE COMPARATOR

Patients will receive closure of the tonsillar fossae following tonsillectomy.

Procedure: Closure of the Tonsillar Fossa

2

ACTIVE COMPARATOR

Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy

Procedure: Tonsillectomy with open fossa

Interventions

Closure of the Tonsillar Fossa PROCEDURE

We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.

1

Tonsillectomy with open fossa PROCEDURE

SOP for a tonsillectomy.

2

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Normal children between that ages of five to ten requiring a tonsillectomy

You may not qualify if:

• Children older than ten years of age.
• Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wayne E Berryhill, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

US (1)