Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03575689 |
| Other study ID # |
H15-03025 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2016 |
| Est. completion date |
May 1, 2019 |
Study information
| Verified date |
September 2019 |
| Source |
St. Paul's Hospital, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Septoplasty is one of the most performed surgeries in rhinology as a solo procedure, or in
combination with sinus surgery. The procedure for septoplasty and postoperative management
has evolved over time based on several studies that have been done. The current standard of
care in our centre is to conduct a septoplasty using quilting technique and apply Doyle
splints in both nostrils to stabilize the septum for 6 days. However these splints are
associated with morbidity in the post-op period. The quilting technique was developed to
prevent complications and stabilize the septum. This study examines the efficacy of these
splints in stabilizing the septum and preventing complications after septoplasty
Description:
1. Purpose
To compare the success rate of septoplasty in correcting the nasal septal deviation
(with regards to nasal obstruction and intranasal access) among patient who used Doyle
splints and those who did not. The investigators will also determine if patient's
quality of life in the postoperative period is affected by the use of Doyle splints or
not.
2. Hypothesis
Is there a significant difference in success rates of septoplasty in patients who used a
Doyle nasal splint when compared with patients who did not use the Doyle nasal splint?
Null hypothesis There is no significant difference in success rates of septoplasty in
patients who used a Doyle nasal splint when compared with patients who did not use the
Doyle nasal splint.
3. Justification
Currently in most North American rhinology clinics, nasal splints are used after
septoplasty (using the quilting technique) to improve stability of the nasal septum. The
quilting technique in addition to reduction of other complications was developed to
improve septal stability after septoplasty. No study has been conducted to examine the
efficacy of using only the quilting method when compared to the current standard of care
which adds extra cost to the surgery. This study aims to evaluate the efficacy of the
quilting technique in improving stability of the nasal septum among patients using nasal
splints and those not on nasal splints after septoplasty.
A recent study (Objective usefulness of thin silastic septal splints after septal
surgery; i Jung, M.D., Kim, M.D. et al Am J Rhinol Allergy 25, 182-185, 2011) has shown
Insertion of a silastic septal splint after septal surgery should be accepted as a
routine procedure. Our study is aiming to show that quilting suture in x-shaped fashion
technique is as effective and safe as using them yet avoids the potential complication
of discomfort/pain/toxic shock syndrome etc.
The essence of this study is to show that using the quilting suture technique alone
without splints is as good as when used with splints. No other study has been done to
investigate this.
4. Objectives
Primary Objective To compare the success rate of septoplasty in correcting the nasal
septal deviation (with regards to nasal obstruction and intranasal access) among patient
who used Doyle splints and those who did not.
Secondary Objectives To determine if patient's quality of life in the postoperative
period is affected by the use of Doyle splints or not.
5. Research Method
This is a Single blind Randomized Control Trial.
Procedure
The study population will be consecutive patients diagnosed with nasal septal deviation
and who are undergoing nasal septal surgery. It will be a single blind randomized
control trial. Allocation concealment will be ensured by the use of sequentially
numbered, opaque, sealed envelopes. An assessor blinded to which patient is using Doyle
splints will assess the primary outcome.
Consent will be obtained for this study prior to the surgery.
Blinding The study will be single-blinded study. The patients will be randomized into 2
arms/groups. An assessor blinded to which patient got the Doyle splints will assess the
primary outcome.
There will be two possible scenarios resulting from randomization: All patients will
undergo septoplasty using quilting technique.
A. The Doyle splint will be places in both nostrils of the patient after septoplasty.
The doyle splints will be removed 6 days after surgery as per standard of care. No other
procedures will be changed during the surgery.
B. No Doyle splints will be placed in the nostrils of the patient after septoplasty. All
standart of care visits will remain the same.
The PI will be the blinded assessor. The choice of which patient gets a Doyle splint
will be randomized using the sealed envelope system mentioned above.
The randomization will be balanced to ensure that both arms have patients with extensive
surgeries as well as isolated NSRs
6. Statistical Analysis
Sample size calculations Due to lack of data on failure rates of septoplasty in our centre,
an a priori sample size calculation was used to determine the number of participants required
to adequately compare the use of nasal splints. Given that this clinical trial is designed to
investigate equivalency between the use of nasal splints and the lack thereof, an equivalency
sample size calculation was performed. An equivalency limit of 5% was considered clinically
significant from consultation with our expert rhinologist. A previously conducted study
estimating failure and revision rates have estimated that the failure rate was 8%16. If there
is truly no difference between the use of splints or lack thereof, then 88 patients (44
patients per group) will be required to be 80% sure that the limits of a two-sided confidence
interval will exclude a difference in means of more than 5%. Accounting for dropout rates of
10%, a total of 96 patients (48 patients per group) will be required for this study.
Statistical Comparisons The primary objective of this randomized controlled trial will be to
compare the success rates of septoplasty in patents with and without use of nasal splints up
to 90 days post-surgery. Count and absolute percentages of rates will be reported. The
Chi-Squared test will be used to determine statistical significance between rates.
Probability values less than 5% (α=0.05) will be considered significant. Corresponding odds
ratios and 95% confidence intervals will be reported.
For the secondary outcome measures (e.g. VAS, NOSE), results will be summated and considered
as continuous, numerical variables. Descriptive statistics using mean, median, standard
deviation and inter-quartile ranges will be reported. The unpaired two sample student t-tests
will be applied to investigate the difference between the means of the various outcome
measures. Probability values less than 5% (α =0.05) will also be considered statistically
significant.
Baseline demographics and clinical factors will be compared between each treatment group to
determine whether randomization yielded comparable groups. Multivariable logistic and linear
regression will be used to investigate the relationships in the primary and secondary
outcomes.
