Unilateral Cleft LipNCT05080855
Comparison of Techniques in Repair of Unilateral Cleft Lip
A study testing modified Millard technique vs Tennison-Randall technique in people with Unilateral Cleft Lip, run by Cairo University at 1 site in Egypt.
Trial summary
Over the past century, there have been major advances in unilateral cleft-lip repair techniques toward the method's modern form. The first documented cleft-lip repair involved simple freshening and approximation of the cut cleft edges, followed by the use of curved incisions to allow lengthening of the lip. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- modified Millard technique vs Tennison-Randall technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2018to 5 Feb 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 2 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with age from 2 months old to 6 months old.
- Patient with unilateral cleft lip complete or incomplete type.
Who cannot join
- Patient with age less than 2 months old or more than 6 months old.
- Patients with bilateral cleft lip
- Patients with recurrent cleft lip.
- Patients with associated major congenital anomalies like major cardiac anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unilateral Cleft Lip Repair: Quantitative (Anthropometric) Comparative Assessment of Modified Millard vs Tennison-Randall Techniques.
Over the past century, there have been major advances in unilateral cleft-lip repair techniques toward the method's modern form. The first documented cleft-lip repair involved simple freshening and approximation of the cut cleft edges, followed by the use of curved incisions to allow lengthening of the lip. Straight-line closure repairs were used in the early 1900; however, straight-line closures had the disadvantage of creating a vertical scar contracture, leading to notching of the lip. This led to the development of several methods in the mid-twentieth century that are grouped as quadrangular flaps, triangular flaps, and rotation-advancement techniques.
The two basic techniques that are most commonly used for unilateral cleft lip (UCL) closure are the Tennison-Randall and the Millard rotation_advancement techniques. both techniques address the importance of repositioning the lip muscle (orbicularis oris) in the correct anatomic orientation for optimal aesthetic and functional outcomes.
Read more
The ultimate goal of cleft lip surgery is to achieve a perfectly symmetrical lip and nose. It has been shown that for the general population, the more symmetrical the face, the more attractive the face is. The appearance and symmetry of the nasolabial region is also seen as one of the most important characteristics when evaluating the results of any facial surgery.
Measurement of treatment outcome is vital to evaluate the success of cleft management and the degree of improvement, especially in the present age of evidence-based medicine where treatment guidelines for best practice are becoming an integral part of contemporary clinical practice.
The good goal of cleft lip repair is a symmetrical and balanced lip with minimal scar restoring the natural contours of the face, as well as correcting functional anatomy.
Objectives To evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison_ Randall technique in unilateral cleft lip (ucl) repair.
- Conditions
- Unilateral Cleft Lip
- Being tested
- modified Millard technique vs Tennison-Randall technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Millard technique vs Tennison-Randall techniqueProcedure or surgery
evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison-Randall technique in unilateral cleft lip (ucl) repair. Inclusion criteria: Patient with ages from 2 months old to 6 months old, Patient with unilateral cleft lip complete or incomplete type.
| Study group | Role | What they receive |
|---|---|---|
| the cleft lip will be repaired by modified Millard technique | Active comparator | In the modified Millard technique, points (nasal and Vermilion border points) and lines (rotational and advancement flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created three flaps: advancement flap, rotational flap, and c flap. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. Using a vicryl 5-0, we sutured the anterior nasal floor; then, using vicryl 4-0, we sutured the alar base and muscle. Using vicryl 6-0, we sutured top of philtral column with point a, the peak of Cupid's bow, and tip of c flap with alar base. The suturing of mucosal lip was carried out using a vicryl 5-0. Receives: Procedure: modified Millard technique vs Tennison-Randall technique |
| the cleft lip will be repaired by Tennison-Randall technique. | Active comparator | In the Tennison-Randall technique, points (nasal and Vermilion border points) and lines (Skin triangle flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created equilateral triangle flap and releasing incision. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. The suturing of the anterior nasal floor, alar base, and muscle followed the same principles of the modified Millard technique. The cutaneous repair was done by suturing the top of philtral column, the peak of Cupid's bow, point a, the line between the top of philtral column and the peak of Cupid's bow with b-8 and 3-a with b-a. Receives: Procedure: modified Millard technique vs Tennison-Randall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Post-operative Complications
Early:
Wound infection. Wound dehiscence.
Late:
Wound scarring. Lip notch
Measured: 1 month
Secondary outcomes (3)
Anthropometry assessment of Cosmetic Results
Anthropometric measurements were recorded from a two dimensional full-frontal facial photograph of subjects will be taken with a digital camera. The following anthropometric measurements will be taken. Preoperative(measurements will be taken before the surgery).
Vertical lip height on( both cleft and non-cleft side), Horizontal lip length on( both cleft and non-cleft side), Nasal width, Total nasal width.
Postoperative (measurements will be taken three months after the surgery). Vertical lip height on( both cleft and non-cleft side), Horizontal lip length on( both cleft and non-cleft side), Nasal width, Total nasal width.
Measured: patients were assessed before the operation and followed for 3-4 weeks after.
Satisfaction score
by patient parent's satisfaction.
Measured: 24 hours after the operation
Operative time
from the first landmark design to the last suture.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start5 Jun 2018
- Primary completion10 Nov 2019
- Study completion5 Feb 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Salah Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080855
- Sponsor's protocol ID
- 150318
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- 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 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Cleft Lip Repair: Quantitative (Anthropometric) Comparative Assessment of Modified Millard vs Tennison-Randall Techniques.
- ClinicalTrials.gov ID
- NCT05080855
- Acronym / sponsor ID
- 150318
- Conditions
- Unilateral Cleft Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 18 Oct 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.
Over the past century, there have been major advances in unilateral cleft-lip repair techniques toward the method's modern form. The first documented cleft-lip repair involved simple freshening and approximation of the cut cleft edges, followed by the use of curved incisions to allow lengthening of the lip. Straight-line closure repairs were used in the early 1900; however, straight-line closures had the disadvantage of creating a vertical scar contracture, leading to notching of the lip. This led to the development of several methods in the mid-twentieth century that are grouped as quadrangular flaps, triangular flaps, and rotation-advancement techniques.
The two basic techniques that are most commonly used for unilateral cleft lip (UCL) closure are the Tennison-Randall and the Millard rotation_advancement techniques. both techniques address the importance of repositioning the lip muscle (orbicularis oris) in the correct anatomic orientation for optimal aesthetic and functional outcomes.
The ultimate goal of cleft lip surgery is to achieve a perfectly symmetrical lip and nose. It has been shown that for the general population, the more symmetrical the face, the more attractive the face is. The appearance and symmetry of the nasolabial region is also seen as one of the most important characteristics when evaluating the results of any facial surgery.
Measurement of treatment outcome is vital to evaluate the success of cleft management and the degree of improvement, especially in the present age of evidence-based medicine where treatment guidelines for best practice are becoming an integral part of contemporary clinical practice.
The good goal of cleft lip repair is a symmetrical and balanced lip with minimal scar restoring the natural contours of the face, as well as correcting functional anatomy.
Objectives To evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison_ Randall technique in unilateral cleft lip (ucl) repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the cleft lip will be repaired by modified Millard technique | Active comparator | Procedure: modified Millard technique vs Tennison-Randall techniqueIn the modified Millard technique, points (nasal and Vermilion border points) and lines (rotational and advancement flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created three flaps: advancement flap, rotational flap, and c flap. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. Using a vicryl 5-0, we sutured the anterior nasal floor; then, using vicryl 4-0, we sutured the alar base and muscle. Using vicryl 6-0, we sutured top of philtral column with point a, the peak of Cupid's bow, and tip of c flap with alar base. The suturing of mucosal lip was carried out using a vicryl 5-0. |
| the cleft lip will be repaired by Tennison-Randall technique. | Active comparator | Procedure: modified Millard technique vs Tennison-Randall techniqueIn the Tennison-Randall technique, points (nasal and Vermilion border points) and lines (Skin triangle flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created equilateral triangle flap and releasing incision. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. The suturing of the anterior nasal floor, alar base, and muscle followed the same principles of the modified Millard technique. The cutaneous repair was done by suturing the top of philtral column, the peak of Cupid's bow, point a, the line between the top of philtral column and the peak of Cupid's bow with b-8 and 3-a with b-a. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient with age from 2 months old to 6 months old.
- Patient with unilateral cleft lip complete or incomplete type.
Key exclusion criteria (4 listed)
- Patient with age less than 2 months old or more than 6 months old.
- Patients with bilateral cleft lip
- Patients with recurrent cleft lip.
- Patients with associated major congenital anomalies like major cardiac anomalies.
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 |
|---|---|---|
| modified Millard technique vs Tennison-Randall techniqueevaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison-Randall technique in unilateral cleft lip (ucl) repair. Inclusion criteria: Patient with ages from 2 months old to 6 months old, Patient with unilateral cleft lip complete or incomplete type. | Procedure or surgery | the cleft lip will be repaired by Tennison-Randall technique., the cleft lip will be repaired by modified Millard technique |
Primary outcome
Assessment of Post-operative Complications
Time frame: 1 month
Early: Wound infection. Wound dehiscence. Late: Wound scarring. Lip notch
3 secondary outcomes
Anthropometry assessment of Cosmetic Results
Time frame: patients were assessed before the operation and followed for 3-4 weeks after.
Satisfaction score
Time frame: 24 hours after the operation
Operative time
Time frame: intraoperatively
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 18 Oct 2021.
- Individual participant dataSharing planned: No
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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 modified Millard technique vs Tennison-Randall technique in people with Unilateral Cleft Lip, run by Cairo University 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 4 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 18 Oct 2021. 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?
Assessment of Post-operative Complications (time frame: 1 month). 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 18 Oct 2021.