Injection Versus Suture Repair of Laryngeal Clefts
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
128 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Derek Lam, MD MPH
Data sourced from clinicaltrials.gov
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