Complete Unilateral Cleft LipNCT05102513
Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
A study testing Unilateral Cleft Lip Repair: Hybrid Technique and Unilateral Cleft Lip Repair: Millard 2 Technique in people with Complete Unilateral Cleft Lip, run by Marco Kesting at 1 site in Germany.
Trial summary
Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Complete Unilateral Cleft Lip
- What is being tested?
- Unilateral Cleft Lip Repair: Hybrid Technique and Unilateral Cleft Lip Repair: Millard 2 Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Complete unilateral cleft lip and palate
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Mund-, Kiefer- und Gesichtschirurgische Klinik
Erlangen, Bavaria, 91054
About this study
Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.
However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.
- Conditions
- Complete Unilateral Cleft Lip
- Being tested
- Unilateral Cleft Lip Repair: Hybrid Technique, Unilateral Cleft Lip Repair: Millard 2 Technique
- Keywords
- Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Cleft Lip Repair: Hybrid TechniqueProcedure or surgery
The rotation flap of the Millard II technique was expanded by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was lengthened by a wave cut as known from the Pfeiffer procedure. For the vermillion a Noordhoff plasty is applied.
Unilateral Cleft Lip Repair: Millard 2 TechniqueProcedure or surgery
A curved incision is marked skirting the philtral ridge. If more length is required a back-cut incision can be performed. The C-flap is outlined by the incision just marked and the incision along red-white border up to the base of the columella. On the cleft side an advancement flap is designed. For the vermillion a Noordhoff plasty is applied.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Cleft Lip Repair with the New Hybrid Technique | Experimental | Not described Receives: Procedure: Unilateral Cleft Lip Repair: Hybrid Technique |
| Unilateral Cleft Lip Repair with the Millard II Technique | Active comparator | Not described Receives: Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the length of the philtral colomn on the cleft and non-cleft side
Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos.
Measured: perioperatively to 6 month postoperatively
Angle of the columella
A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos.
Measured: perioperatively
Distance from the midpoint of the columella to the lateral alae
Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos.
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Unilateral Cleft LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Kesting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Kesting, University Hospital Erlangen
- Investigators
- Marco Kesting, Prof Dr Dr, Principal investigator, Mund-, Kiefer- und Gesichtschirurgie Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102513
- Sponsor's protocol ID
- 20211010
- Status last verified
- May 2022
- First submitted
- 19 Oct 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
- ClinicalTrials.gov ID
- NCT05102513
- Acronym / sponsor ID
- 20211010
- Conditions
- Complete Unilateral Cleft Lip
- Keywords
- Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marco KestingUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.
However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
| Arm | Type | Receives |
|---|---|---|
| Unilateral Cleft Lip Repair with the New Hybrid Technique | Experimental | Procedure: Unilateral Cleft Lip Repair: Hybrid Technique |
| Unilateral Cleft Lip Repair with the Millard II Technique | Active comparator | Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Complete unilateral cleft lip and palate
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Cleft Lip Repair: Hybrid TechniqueThe rotation flap of the Millard II technique was expanded by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was lengthened by a wave cut as known from the Pfeiffer procedure. For the vermillion a Noordhoff plasty is applied. | Procedure or surgery | Unilateral Cleft Lip Repair with the New Hybrid Technique |
| Unilateral Cleft Lip Repair: Millard 2 TechniqueA curved incision is marked skirting the philtral ridge. If more length is required a back-cut incision can be performed. The C-flap is outlined by the incision just marked and the incision along red-white border up to the base of the columella. On the cleft side an advancement flap is designed. For the vermillion a Noordhoff plasty is applied. | Procedure or surgery | Unilateral Cleft Lip Repair with the Millard II Technique |
Primary outcome
Measurement of the length of the philtral colomn on the cleft and non-cleft side
Time frame: perioperatively to 6 month postoperatively
Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos.
Angle of the columella
Time frame: perioperatively
A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos.
Distance from the midpoint of the columella to the lateral alae
Time frame: perioperatively
Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
Related trials for Complete Unilateral Cleft Lip
Not yet recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
Cleft Palate, Cleft Palate, Unilateral, Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Kesting, Prof Dr Dr principal investigator
Mund-, Kiefer- und Gesichtschirurgie Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Cleft Lip Repair: Hybrid Technique and Unilateral Cleft Lip Repair: Millard 2 Technique in people with Complete Unilateral Cleft Lip, run by Marco Kesting at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Kesting, Prof Dr Dr (+49 9131 8533601, mkg-chirurgie@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the length of the philtral colomn on the cleft and non-cleft side (time frame: perioperatively to 6 month postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.