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Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

Primary Purpose

Cleft Palate

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cleft palate repair
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate

Eligibility Criteria

6 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of cleft palate.
  • Primary palate repair.

Exclusion Criteria:

  • Severe general disease
  • Confirmed hereditary hearing loss or neuropathic hearing loss.
  • Received any kind of audiological or otological therapy before.
  • Patients and/or his/her don't want to continue the clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Langerbeck's repair

    restoration of levator veli palatini

    mordified restoration of tensor veli palatini

    Arm Description

    Langerbeck's repair of cleft palate,without specific restoration of levator veli palatini or tensor veli palatini. Incisions along the margins of the cleft at the junction of oral and nasal mucosa. Lateral relaxing incisions were performed and the mucoperiosteal flap of hard palate were elevated on both sides except the ones with only soft palate cleft. The anterior end of the mucoperiosteal flap may be cut off for the purpose of tension relieving and would be resutured to the anterior area during closing. In the soft palate, the division was made between the oral mucous layer and the palatal musculature layer. Hamulus were broken for closing the cleft without tension. Closing was done by two seperated layers, one layer of nasal mucosa-palatal muscle, and one layer of oral mucosa.

    The incision was made similar to Langerbeck's repair. During disection, the levator veli palatini was identified after the elevation of flap. The levator veli palatini was separate from the oral and nasal mucosa. During closing, the anterior end of levator veli palatini was rotated towards the midline and the two muscle bundle from the two sides were sutured in the midline. In this process, the tensor veli palatini was not intentionally identified or dissected.

    Incision was made similar to Langerbeck's repair. During disection, the tensor veli palatini was identified after flap elevation. Its tendinous fibers was released from but still connected to the pterygoid process without breaking the hamulus or cutting off the tendinous fibers. If the tension is too strong during suturing, the tensor tendon could be partly dissected laterally meanwhile be kept continuity medially so that the tensor veli palatini could be rotated more medially. The levator veli palatini, tensor veli palatini, together with the palatine aponeurosis and the nasal mucosa from two sides were sutured in the middle line. The tensor veli palatini may not be jointed to the contralateral one directly.

    Outcomes

    Primary Outcome Measures

    Hearing level
    Auditory brainstem response was tested in all three groups after surgery. The air conductive hearing threshold was used to assess the hearing level.
    The otological status of middle ear
    226 tympanometry was tested in all three groups after surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.
    Hearing level
    Auditory brainstem response was tested in all three groups before surgery. The air conductive hearing threshold was used to assess the hearing level.
    The otological status of middle ear
    226 tympanometry was tested in all three groups before surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2020
    Last Updated
    April 26, 2020
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04366674
    Brief Title
    Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair
    Official Title
    The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    January 31, 2019 (Actual)
    Study Completion Date
    June 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and merely levator veli palatini restoration.
    Detailed Description
    71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients who received Langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. Group 2: patients who received palate surgery with special levator veli palatini restoration. Group 3: patients who received palate surgery with modified tensor veli palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were used to test the audiological and otological status of the three groups. Preoperative and postoperative results were compared intragroup and intergroup.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Palate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Langerbeck's repair
    Arm Type
    Active Comparator
    Arm Description
    Langerbeck's repair of cleft palate,without specific restoration of levator veli palatini or tensor veli palatini. Incisions along the margins of the cleft at the junction of oral and nasal mucosa. Lateral relaxing incisions were performed and the mucoperiosteal flap of hard palate were elevated on both sides except the ones with only soft palate cleft. The anterior end of the mucoperiosteal flap may be cut off for the purpose of tension relieving and would be resutured to the anterior area during closing. In the soft palate, the division was made between the oral mucous layer and the palatal musculature layer. Hamulus were broken for closing the cleft without tension. Closing was done by two seperated layers, one layer of nasal mucosa-palatal muscle, and one layer of oral mucosa.
    Arm Title
    restoration of levator veli palatini
    Arm Type
    Active Comparator
    Arm Description
    The incision was made similar to Langerbeck's repair. During disection, the levator veli palatini was identified after the elevation of flap. The levator veli palatini was separate from the oral and nasal mucosa. During closing, the anterior end of levator veli palatini was rotated towards the midline and the two muscle bundle from the two sides were sutured in the midline. In this process, the tensor veli palatini was not intentionally identified or dissected.
    Arm Title
    mordified restoration of tensor veli palatini
    Arm Type
    Experimental
    Arm Description
    Incision was made similar to Langerbeck's repair. During disection, the tensor veli palatini was identified after flap elevation. Its tendinous fibers was released from but still connected to the pterygoid process without breaking the hamulus or cutting off the tendinous fibers. If the tension is too strong during suturing, the tensor tendon could be partly dissected laterally meanwhile be kept continuity medially so that the tensor veli palatini could be rotated more medially. The levator veli palatini, tensor veli palatini, together with the palatine aponeurosis and the nasal mucosa from two sides were sutured in the middle line. The tensor veli palatini may not be jointed to the contralateral one directly.
    Intervention Type
    Procedure
    Intervention Name(s)
    cleft palate repair
    Intervention Description
    restoration of tensor veli palatini for the purpose of the muscle function recovery.
    Primary Outcome Measure Information:
    Title
    Hearing level
    Description
    Auditory brainstem response was tested in all three groups after surgery. The air conductive hearing threshold was used to assess the hearing level.
    Time Frame
    3 months after surgery
    Title
    The otological status of middle ear
    Description
    226 tympanometry was tested in all three groups after surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.
    Time Frame
    3 months after surgery
    Title
    Hearing level
    Description
    Auditory brainstem response was tested in all three groups before surgery. The air conductive hearing threshold was used to assess the hearing level.
    Time Frame
    0 to 3 months before surgery
    Title
    The otological status of middle ear
    Description
    226 tympanometry was tested in all three groups before surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.
    Time Frame
    0 to 3 months before surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    60 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of cleft palate. Primary palate repair. Exclusion Criteria: Severe general disease Confirmed hereditary hearing loss or neuropathic hearing loss. Received any kind of audiological or otological therapy before. Patients and/or his/her don't want to continue the clinical trial.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lian Zhou, D.D.S
    Organizational Affiliation
    Peking Union Medical College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

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