Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 128
- Locations
- 4
- Primary Endpoint
- Resolution of penetration/aspiration
Study Overview
Brief Summary
The purpose of the study is to learn more about a procedure that may be helpful for the participant's swallowing issues. The investigators are hoping to find out if one type of procedure is the same or better than another type of procedure at improving participant's issues with swallowing.
Participants will get one of two procedures. One is called injection laryngoplasty (IL) and injects a gel into the back wall of the participant's airway to prevent food and liquid from falling in. The other procedure is called endoscopic suture repair (ER) and uses sutures to sew together and build up the back wall of the participant's airway to prevent food and liquid from falling in. Participants will be asked to have a number of tests and procedures. These include a modified barium swallow study, in which the participant drinks and eats foods and liquids with barium in them and X-rays are used to assess how the food moves through the participant's body. This will be done before the procedure and 3 months after the procedure. The investigators will also give participants questionnaires to complete before and after the procedure.
Detailed Description
This study has 2 study groups.
- Group 1 will get IL for this condition.
- Group 2 will get ER for this condition
A computer will assign each participant to a group in no particular order. This is called randomization. Half of participants in this study will get IL. Half of participants will get ER. Each participant will have an equal chance of being in either group.
Neither the participants, the study doctor(s), nor the speech pathologist will know whether each participant will get the IL or ER. Only the surgeon will know which treatment the participant gets. The study is done this way because knowing which method the participant receives can change the results of the study.
If participants experience any serious side effects, the study doctor can find out which method they received so that any side effects can be treated properly.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •children aged 12 months - 10 years referred to a multi-disciplinary aerodigestive clinic with evidence of penetration or aspiration on VFSS, requiring any amount of thickening of liquids and unable to wean after 2-month trial of thickened liquids.
Exclusion Criteria
- •Cerebral palsy
- •Down syndrome
- •Prematurity < 28 weeks gestational age
- •Hypoxic brain injury
- •Any syndrome with significant hypotonia
- •History of nothing by mouth (NPO) for > 1 month prior to assessment
- •>50% of nutrition by G-tube
- •Tracheostomy
- •History of prior IL or ER
Arms & Interventions
Endoscopic suture repair
Children receiving endoscopic suture repair of laryngeal cleft
Intervention: Endoscopic suture repair (Procedure)
Injection laryngoplasty
Children receiving injection of the interarytenoid space of laryngeal cleft
Intervention: Injection laryngoplasty (Procedure)
Outcomes
Primary Outcomes
Resolution of penetration/aspiration
Time Frame: 3 months post operative
No thickener needed on speech pathologist assessment of video fluoroscopic swallow study
Secondary Outcomes
- change in quality of life scores(at enrollment and 3 months post intervention)
- Compare change in recommended liquid thickness(at enrollment and 3 months post intervention)
- change in feeding and swallowing impact survey (FSIS) scores(at enrollment and 3 months post intervention)
- change in penetration/aspiration score(at enrollment and 3 months post intervention)
- Change in laryngeal cleft quality of life (LC-QOL) scores(at enrollment and 3 months post intervention)
Investigators
Derek Lam, MD, MPH
Professor
American Academy of Otolaryngology-Head and Neck Surgery Foundation