Trial Outcomes & Findings for Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty (NCT NCT01541839)

Results Overview

The primary outomce of this study is to determine if time is saved in the operating room by using the septal stapler instead of suture.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

1 day

Results posted on

2023-01-11

Participant Flow

Patients were recruited from the Otolaryngology clinic from February 2012 to May 2012

Participant milestones

Participant milestones
Measure	Septal Stapler This group will have closure of their nasal septal flaps via septal stapler.	Control (Suture) This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Septal Stapler n=8 Participants This group will have closure of their nasal septal flaps via septal stapler.	Control (Suture) n=8 Participants This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 15 • n=5 Participants	35 years STANDARD_DEVIATION 14 • n=7 Participants	38 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Canada	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Based on sample size calculation. No patients lost to follow-up

The primary outomce of this study is to determine if time is saved in the operating room by using the septal stapler instead of suture.

Outcome measures

Outcome measures
Measure	Septal Stapler n=8 Participants This group will have closure of their nasal septal flaps via septal stapler.	Control (Suture) n=8 Participants This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Operative Time	35 seconds Standard Deviation 23	423 seconds Standard Deviation 70

SECONDARY outcome

Timeframe: up to 2 months

Population: All participants. None lost to follow-up

The subjective outcome of patients undergoing closure with the septal stapler versus suture will be assessed via the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE questionnaire rates a patient's symptoms using a 0-4 scale where 0 is "Not a problem" and 4 is "Severe problem"

Outcome measures

Outcome measures
Measure	Septal Stapler n=8 Participants This group will have closure of their nasal septal flaps via septal stapler.	Control (Suture) n=8 Participants This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Subjective Function	2 units on a scale Standard Deviation 3	3 units on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: 3 weeks

Population: All participants

The number of post-operative complications (synechiae, septal perforation) assessed at three-week follow-up by a physician.

Outcome measures

Outcome measures
Measure	Septal Stapler n=8 Participants This group will have closure of their nasal septal flaps via septal stapler.	Control (Suture) n=8 Participants This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.
Post-operative Complications	1 numberof post-operative complications	1 numberof post-operative complications

Adverse Events

Septal Stapler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Suture)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Wright

University of Alberta

Phone: 780-407-7656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place