HemorrhageNCT00394849
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
A study testing suture one tonsillar fossa in people with Hemorrhage and Pain, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Pain
- What is being tested?
- suture one tonsillar fossa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 763 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Childrens' Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Hemorrhage, Pain
- Being tested
- suture one tonsillar fossa
- Keywords
- Tonsillectomy, Suturing of tonsillar pillars, pain, postoperative hemorrhage, bleeding
- Medical subject headings
- Hemorrhage, Pain, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suture one tonsillar fossaProcedure or surgery
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.
| Study group | Role | What they receive |
|---|---|---|
| suture one tonsillar fossa | Experimental | Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. Receives: Procedure: suture one tonsillar fossa |
| One side not sutured | No intervention | Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
which side was more painful on or about postoperative day 14
determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver
Measured: 14 days
Secondary outcomes (4)
Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
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
Measured: 40 days
any other adverse events (complications)
determined if other complications occurred
Measured: 40 days
which side was more painful on or about postoperative day 21
determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver
Measured: 21 days
overall assessment at the postoperative clinic visit (on or about day 28)
determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startJul 2000
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Matt, Indiana University
- Investigators
- Bruce H. Matt, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394849
- Sponsor's protocol ID
- 0006-26
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2006
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Matt BH, Krol BJ, Ding Y, Juliar BE. Effect of tonsillar fossa closure on postoperative pain and bleeding risk after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1799-805. doi: 10.1016/j.ijporl.2012.09.004. Epub 2012 Sep 25.
PubMed 23021465
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy
- ClinicalTrials.gov ID
- NCT00394849
- Acronym / sponsor ID
- 0006-26
- Conditions
- Hemorrhage, Pain
- Keywords
- Tonsillectomy, Suturing of tonsillar pillars, pain, postoperative hemorrhage, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 1 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- sutured one tonsillar fossa. pain was compared side to side. which side was sutured was randomized
| Arm | Type | Receives |
|---|---|---|
| suture one tonsillar fossa | Experimental | Procedure: suture one tonsillar fossaIntervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
| One side not sutured | No intervention | –Intervention: one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suture one tonsillar fossaone tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side. | Procedure or surgery | suture one tonsillar fossa |
Primary outcome
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
4 secondary outcomes
Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event
Time frame: 40 days
any other adverse events (complications)
Time frame: 40 days
which side was more painful on or about postoperative day 21
Time frame: 21 days
overall assessment at the postoperative clinic visit (on or about day 28)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Results publication: PubMed 23021465Matt BH, Krol BJ, Ding Y, Juliar BE. Effect of tonsillar fossa closure on postoperative pain and bleeding risk after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1799-805. doi: 10.1016/j.ijporl.2012.09.004. Epub 2012 Sep 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce H. Matt, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suture one tonsillar fossa in people with Hemorrhage and Pain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
which side was more painful on or about postoperative day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.