NCT04161196

Brief Summary

comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 7, 2019

Last Update Submit

November 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.

    two patients' group in this study , one group will have a Tonsil pillars suturing after the tonsillectomy and the second group will not have this technique after the tonsillectomy, then patience should answer a post pain tonsillectomy questionnaire , by the questionnaire and the checkups to compare how each group affected ( using SPSS program and Statistics Methods.

    1 year

Study Arms (2)

patients with post - tonsillectomy suturing tonsil pillars

ACTIVE COMPARATOR
Procedure: tonsil pillars suturing

patients without post - tonsillectomy suturing tonsil pillars

PLACEBO COMPARATOR
Procedure: tonsillectomy without tonsil pillars suturing

Interventions

The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.

patients with post - tonsillectomy suturing tonsil pillars

tonsillectomy without The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.

patients without post - tonsillectomy suturing tonsil pillars

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 and over.
  • patients with tonsillectomy indication due to chronic Tonsillitis.

You may not qualify if:

  • patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
  • chronic disease, chronic neurology disease.
  • chronic psychology disease.
  • bleeding tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 13, 2019

Study Start

December 1, 2019

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

November 14, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share