Unilateral Cleft LipNCT04607213
Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
A study testing Advancement-rotation approach based on Millard' for repairing lip defect. and Straight-line approach in people with Unilateral Cleft Lip, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients. Read more about this study
- Who is it for?
- Ages 1 day to 4 years
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- Advancement-rotation approach based on Millard' for repairing lip defect. and Straight-line approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Nov 2019to 1 Oct 2020
- 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 1 day to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have complete unilateral cleft lip
- from birth to 4 years old
Who cannot join
- syndromic cleft patient
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)
compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.
Read the detailed description
Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.
- Conditions
- Unilateral Cleft Lip
- Being tested
- Advancement-rotation approach based on Millard' for repairing lip defect., Straight-line approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advancement-rotation approach based on Millard' for repairing lip defect.Procedure or surgery
patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; "cut- as- you-go" by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.
Straight-line approachProcedure or surgery
patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap.
On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.
| Study group | Role | What they receive |
|---|---|---|
| Advancement-rotation approach | Active comparator | Not described Receives: Procedure: Advancement-rotation approach based on Millard' for repairing lip defect. |
| Straight-line approach | Experimental | Not described Receives: Procedure: Straight-line approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in vertical and horizontal lip length
Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
Measured: at 3rd, 6th months
change in lip defect
repaired lip is evaluated by direct visual inspection for the patient evaluation.
Measured: at 1st, 3rd and 6th months
Secondary outcomes (2)
change in degree of labial scaring
Using a five-point scale based on Asher-McDade scoring system:
(very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good).
Measured: at 3rd, 6th months
change in nasal symmetry
measuring total nasal width and nostril width by caliper
Measured: at 3rd, 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start13 Nov 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607213
- Sponsor's protocol ID
- Cleft lip_00010556
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04607213
- Acronym / sponsor ID
- Cleft lip_00010556
- Conditions
- Unilateral Cleft Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 29 Oct 2020 (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.
compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.
Detailed description
Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advancement-rotation approach | Active comparator | Procedure: Advancement-rotation approach based on Millard' for repairing lip defect. |
| Straight-line approach | Experimental | Procedure: Straight-line approach |
Who may qualify
- Ages
- 1 day to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have complete unilateral cleft lip
- from birth to 4 years old
Key exclusion criteria (1 listed)
- syndromic cleft patient
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 |
|---|---|---|
| Advancement-rotation approach based on Millard' for repairing lip defect.patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; "cut- as- you-go" by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill. | Procedure or surgery | Advancement-rotation approach |
| Straight-line approachpatients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap. On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar. | Procedure or surgery | Straight-line approach |
Primary outcome
change in vertical and horizontal lip length
Time frame: at 3rd, 6th months
Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
change in lip defect
Time frame: at 1st, 3rd and 6th months
repaired lip is evaluated by direct visual inspection for the patient evaluation.
2 secondary outcomes
change in degree of labial scaring
Time frame: at 3rd, 6th months
change in nasal symmetry
Time frame: at 3rd, 6th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advancement-rotation approach based on Millard' for repairing lip defect. and Straight-line approach in people with Unilateral Cleft Lip, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 29 Oct 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in vertical and horizontal lip length (time frame: at 3rd, 6th months). The study lists 2 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 29 Oct 2020.