Aim of this study was the comparison of application of an amniotic membrane in tonsillectomy in adults regarding primary outcomes (pain and bleeding).
Design
In this randomized, single blind clinical trial, 60 patients who were candidate for tonsillectomy and eligible for inclusion in the study were selected. Participants were randomly divided into two groups; intervention and control.
Settings and conduct
Since the adoption of the proposal, patients who were candidates for tonsillectomy, were randomly divided into two groups of intervention and control.The randomization method was block randomization. The procedure of surgery were the same in the two groups. surgeries were conducted in Shahid Dastgheib Hospital. All the surgeries were performed by the performer. Outcome of pain was recorded by patient within 7 days after surgery, bleeding (within 14 days after operation) and percentage of wound healing (5, 10 and 15 days after surgery) were assessed by ENT specialist .The assistant co-worker then collected the information and delivered it to the statistician. The outcomes evaluator (physician) and statistician did not know about the procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with 18 years of age or older; Patients undergoing tonsillectomy for indications of recurrent tonsillitis or tonsillar hypertrophy. Exclusion criteria: Patients who had previous peritonsillar abscess, acute infection, coagulatory problems, major organ disease like congestive heart failure, renal failure, hepatic failure or any other internal problems effecting the hemostasis condition.
Intervention groups
In intervention group, the aminiotic membrane used for coverage of muscle flap. In control group, the aminiotic membrane did not used for coverage of muscle flap.
Main outcome variables
Pain, bleeding and percentage of wound healing after tonsillectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131123015496N21
Registration date:2019-06-08, 1398/03/18
Registration timing:retrospective
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-18, 1397/12/27
Actual recruitment start date
2018-12-21, 1397/09/30
Actual recruitment end date
2019-03-18, 1397/12/27
Trial completion date
2019-03-18, 1397/12/27
Scientific title
The impact of application of amniotic membrane on post-tonsillectomy pain and bleeding
Public title
The impact of application of embryonic membrane in surgery to remove tonsils
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 18 years of age or older
Patients undergoing tonsillectomy for indications of recurrent tonsillitis or tonsillar hypertrophy.
Exclusion criteria:
Patients who had previous peritonsillar abscess, acute infection, coagulatory problems, major organ disease like congestive heart failure, renal failure, hepatic failure or any other internal problems effecting the hemostasis condition
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with one person and random numbers 0 to 9.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer and those who evaluate the outcome (physicians) were unaware of the type of material used in practice.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2018-11-23, 1397/09/02
Ethics committee reference number
IR.SUMS.MED.REC.1397.353
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1, J35
ICD-10 code description
Hypertrophy of tonsils, Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
Pain score intensity after tonsillectomy
Timepoint
Three times a day; before breakfast, lunch, dinner for 7 days after surgery
Method of measurement
Visual Analog Scale (VAS)-by patient
2
Description
Post-tonsillectomy bleeding
Timepoint
within 14 days after surgery
Method of measurement
Observation by ENT specialist
Secondary outcomes
1
Description
Percentage of wound healing
Timepoint
5, 10 and 15 days after surgery
Method of measurement
Observation by ENT specialist
Intervention groups
1
Description
Intervention group: The aminiotic membrane used for coverage of muscle flap in intervention group.
Category
Treatment - Surgery
2
Description
Control group: The aminiotic membrane did not used for coverage of muscle flap in control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Dr. Mohammad Faramarzi
Street address
Hafez Street, Next to National Garden
City
Shiraz
Province
Fars
Postal code
71456-83769
Phone
+98 71 3228 8064
Email
dhospital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghasemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Roosta.Sareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Faramarzi
Position
Associate professor of Otolaryngology
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Faramarzi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sareh Roosta
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193616641
Phone
+98 71 3629 1478
Email
Roosta.Sareh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD