Injection Versus Suture Repair of Laryngeal Clefts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic suture repair, Injection laryngoplasty.
- Who it may be relevant to
- Registry conditions: Laryngeal Cleft, Dysphagia. Basic parameters: 12 months — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Injection Versus Suture Repair of Laryngeal Clefts, A Randomized, Controlled Trial
Overview
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.
Participants will need to have the following tests to find out if they can be in the study:
* Physical exam * Demographic information/medical history * Video fluoroscopic swallow study (VFSS) - X-ray videos that allow investigators to watch how food and liquids go down as a participant swallows them
If participant's screening tests show that they can take part in the study and they choose to be part of the study, they will also have to do the following tests:
* VFSS 3 months after the procedure * Questionnaires asking about the emotional and physical burden of participant's swallowing issues, both before and after the procedure * Overnight monitoring in the hospital after the procedure * Follow up in clinic for up to 2 years after the procedure
Participant's medical records may be reviewed. Information reviewed may include treatment history, medications, surgeries, allergies, scans, and lab results.
Once participant's participation in the study ends, their medical provider(s) will help them choose the next step in their care.
Interventions
- Procedure Endoscopic suture repair
Children receiving endoscopic suture repair of laryngeal cleft - Procedure Injection laryngoplasty
Children receiving injection of the interarytenoid space for laryngeal cleft treatment
Primary outcome measures
- Resolution of penetration/aspiration [Time frame: 3 months post operative]
Secondary outcome measures (5)
- Compare change in recommended liquid thickness [Time frame: at enrollment and 3 months post intervention]
- change in penetration/aspiration score [Time frame: at enrollment and 3 months post intervention]
- change in feeding and swallowing impact survey (FSIS) scores [Time frame: at enrollment and 3 months post intervention]
- change in quality of life scores [Time frame: at enrollment and 3 months post intervention]
- Change in laryngeal cleft quality of life (LC-QOL) scores [Time frame: at enrollment and 3 months post intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Oregon Health & Science University — Portland
- Vanderbilt University — Nashville
Identifiers
NCT: NCT07057258 · STUDY00027965