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Trial record 6 of 102 for:    pillar

Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

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ClinicalTrials.gov Identifier: NCT00394849
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.

Condition or disease Intervention/treatment
Hemorrhage Pain Procedure: suture one tonsillar fossa

Detailed Description:
After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 763 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
Masking: Single (Participant)
Masking Description:
did not tell participant which side was sutured.
Primary Purpose: Treatment
Official Title: Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
Study Start Date : July 2000
Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: suture one tonsillar fossa
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
Procedure: suture one tonsillar fossa
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
No Intervention: One side not sutured
Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.


Outcome Measures

Primary Outcome Measures :
  1. which side was more painful on or about postoperative day 14 [ Time Frame: 14 days ]
    determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver


Secondary Outcome Measures :
  1. Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event [ Time Frame: 40 days ]
    Additional information was obtained about details if postoperative bleeding occurred. Specifically, if postoperative bleeding occurred, we sought to obtain as many details as possible about the events. Items such as when the postoperative bleeding occurred, what was done about it, where the subject was treated, and what the outcome was ( was the bleeding controlled, did the subject have other complications or concerns, etc. were elicited

  2. any other adverse events (complications) [ Time Frame: 40 days ]
    determined if other complications occurred

  3. which side was more painful on or about postoperative day 21 [ Time Frame: 21 days ]
    determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver

  4. overall assessment at the postoperative clinic visit (on or about day 28) [ Time Frame: 28 days ]
    determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.

Exclusion Criteria:

  • Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess
Contacts and Locations

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): NCT00394849


Locations
United States, Indiana
Riley Childrens' Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
More Information

Publications:
Responsible Party: Bruce Matt, Associate Professor, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00394849     History of Changes
Other Study ID Numbers: 0006-26
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bruce Matt, Indiana University School of Medicine:
Tonsillectomy
Suturing of tonsillar pillars
pain
postoperative hemorrhage, bleeding

Additional relevant MeSH terms:
Hemorrhage
Pain, Postoperative
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Signs and Symptoms