Lower Lip Tissue LossREFEPLINCT07298070
Functional and Aesthetic Outcomes Following Lower Lip Reconstruction
An observational study of Lower Lip Tissue Loss and Cancer, run by Hôpital NOVO at 1 site in France.
Trial summary
This retrospective study, aims to evaluate the functional and aesthetic results of lower lip reconstructions, incorporating both patient experiences and the analysis of physicians and surgeons working on facial issues (plastic surgeons and dermatologists) in order to optimize future therapeutic strategies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Lip Tissue Loss, Cancer
- What is being tested?
- Patient-Reported Outcome Questionnaire (post-operative)
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include patients over 18 years of age who underwent lower lip reconstruction after excision for skin carcinoma, operated on in Pontoise between January 1, 2014, and October 31, 2025.
Who may be able to join
- Patient over 18 years of age.
- Patients who underwent lower lip reconstruction after excision for skin carcinoma, operated on in Pontoise between January 1, 2014, and October 31, 2025.
- Patients who had a post-operative follow-up consultation (± 2 months).
- Patients who were informed and did not object to participating in the study
Who cannot join
- Cognitive impairment preventing completion of the questionnaire.
- Patient under legal protection (guardianship, conservatorship, or judicial protection).
- Patient deceased.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital NOVO
Cergy-Pontoise, 95300
Veronique DA COSTA, 0033130755069, veronique.dacosta@ght-novo.fr
About this study
This retrospective study, aims to evaluate the functional and aesthetic results of lower lip reconstructions, incorporating both patient experiences and the analysis of physicians and surgeons working on facial issues (plastic surgeons and dermatologists) in order to optimize future therapeutic strategies.
Read the detailed description
Most lip tissue loss is secondary to cancer resection, but other causes may be responsible for this loss, whether in the upper or lower lip: trauma, infectious diseases, giant congenital nevi, hemangiomas, or clefts (labial or cleft palate).
Although the overall 5-year survival rate for skin cancers of the lip is 95%, the long-term quality of life of patients remains a major issue. The lip is both a functional and aesthetic unit, essential for speech, articulation, lip competence, eating, and facial expression.
Reconstructing extensive loss of substance in the upper and lower lips remains a surgical challenge due to the complexity of the perioral musculature and soft tissues. Despite significant advances in free transfers, locoregional flaps remain important in subtotal lip reconstruction, offering better tissue and color adaptation, partial preservation of muscle dynamics, and reduced surgical morbidity.
Reconstruction techniques vary depending on the extent of tissue loss. For defects affecting approximately half of the lip, Abbe or Estlander cross flaps using similar tissue allow functional reinnervation within 6 to 12 months. However, use of these techniques is limited by the risk of microstomia. For more extensive tissue loss (exceeding 50% of the lip), advancement or rotation flaps, such as Gilles, Bernard-Webster, or Karapandzic flaps, are preferred. Finally, tissue loss exceeding 80% or extending beyond the labio-mental sulcus or toward the cheek often requires free tissue transfer, with the risk of impaired lip function and a less than optimal aesthetic result.
Historically, the gold standard technique for lower lip reconstruction is that described by Camille Bernard in 1853, modified by Webster in 1960. Although traditionally considered adynamic due to the sectioning of the perioral muscles, clinical experience suggests that preserving the modiolus and its muscular attachments allows for the maintenance of some tone and mobility in the long term. This structure, the point of convergence of the superficial and deep fascias, plays a key role in lip dynamics by connecting the elevators, depressors, and lateral retractors.
A few studies describe facial reconstruction techniques, with the reference for the lower lip being that described by Camille Bernard in 1853, reviewed by Webster in 1960, but few if any of them focus on the functional and aesthetic results after reconstruction. For example, the retrospective analysis conducted by J. Faulhaber's team reports patient satisfaction in terms of aesthetics and function at the usual follow-up appointment, without substantiating the reasons for this alleged satisfaction. In the study conducted by E. E. Ünsal Tuna et al, a questionnaire was developed to collect functional and aesthetic outcomes from patients, but it was completed by healthcare professionals during a follow-up appointment. The same is true in the prospective study conducted by R. Denadai et al, where although patients are asked about their overall satisfaction with the functional aspect of the reconstruction, it is nevertheless healthcare professionals who more accurately assess the functional results after the reconstruction.
This study therefore focuses on analyzing the post-operative experience of patients, as well as gathering the analysis of doctors and surgeons working on facial issues (plastic surgeons and dermatologists). The aim of the study is to optimize future therapeutic strategies by providing factual information to help decide between the various therapeutic options. It is important to ensure optimal patient care, guaranteeing aesthetic and functional satisfaction, combined with an acceptable quality of life.
- Conditions
- Lower Lip Tissue Loss, Cancer
- Being tested
- Patient-Reported Outcome Questionnaire (post-operative)
- Keywords
- Aesthetic and functional outcomes after lower lip reconstruction, Patient-reported outcome questionnaire, Post-operative, Aesthetic and functional satisfaction, Quality of life, Optimal patient care, Analysis of physicians and surgeons working on topics related to the face
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcome Questionnaire (post-operative)Other
The patient must complete two questionnaires to assess the functional and aesthetic outcomes and quality of life after lower lip reconstruction. No intervention was assigned by the investigator; the surgery was part of routine clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction with the functional and aesthetic outcomes of lip reconstruction at 12 months postoperatively, assessed by a self-reported questionnaire.
On the questionnaire, the patient is asked to rate from 1 to 10, where 1 means "strongly disagree" and 10 means "strongly agree."
Measured: 12 months postoperatively (data collected upon return of completed questionnaire)
Secondary outcomes (5)
Correlation between overall patient satisfaction and various functional and aesthetic aspects of the face and their impact on daily life.
On the questionnaire, at the end of each subsection, the patient is asked to rate from 1 to 10, where 1 means "strongly disagree" and 10 means "strongly agree."
Measured: 12 months postoperatively (data collected upon return of completed questionnaire)
Postoperative complications up to one year after surgery
Postoperative complications lasting up to one year, including nonunion, the need for revision surgery, and in particular commissuroplasty.
Measured: Postoperative period from day 0 to one year
Quality of life one year after surgery
Quality of Life Questionnaire: University of Washington Quality of Life Questionnaire
Measured: 12 months postoperatively (data collected upon return of completed questionnaire)
Compare patients' aesthetic perceptions with those of professionals
Correlation between aesthetic satisfaction perceived by patients and the one assessed by professionals, using a patient-reported outcome questionnaire and another questionnaire for professionals to evaluate the aesthetic appearance after reconstruction
Measured: 12 months postoperatively (data collected upon return of completed questionnaire)
Demonstrate a correlation between the aesthetic success of the procedure and the technical complexity of its execution.
Evaluation of aesthetic results and technical complexity of procedures based on the technique used, using a questionnaire intended for physicians and surgeons working on topics related to the face
Measured: 12 months postoperatively (data collected upon return of completed questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start21 Apr 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Lip Tissue LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AL TABAA AL TABAA, Dr, Principal investigator, Hôpital NOVO - Site Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298070
- Sponsor's protocol ID
- CHRD1425
- Other IDs
- 2025-A01933-46
- Acronym
- REFEPLI
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 9 Jun 2026
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Aesthetic Outcomes Following Lower Lip Reconstruction
- ClinicalTrials.gov ID
- NCT07298070
- Acronym / sponsor ID
- REFEPLI / CHRD1425
- Conditions
- Lower Lip Tissue Loss, Cancer
- Keywords
- Aesthetic and functional outcomes after lower lip reconstruction, Patient-reported outcome questionnaire, Post-operative, Aesthetic and functional satisfaction, Quality of life, Optimal patient care, Analysis of physicians and surgeons working on topics related to the face
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
This retrospective study, aims to evaluate the functional and aesthetic results of lower lip reconstructions, incorporating both patient experiences and the analysis of physicians and surgeons working on facial issues (plastic surgeons and dermatologists) in order to optimize future therapeutic strategies.
Detailed description
Most lip tissue loss is secondary to cancer resection, but other causes may be responsible for this loss, whether in the upper or lower lip: trauma, infectious diseases, giant congenital nevi, hemangiomas, or clefts (labial or cleft palate).
Although the overall 5-year survival rate for skin cancers of the lip is 95%, the long-term quality of life of patients remains a major issue. The lip is both a functional and aesthetic unit, essential for speech, articulation, lip competence, eating, and facial expression.
Reconstructing extensive loss of substance in the upper and lower lips remains a surgical challenge due to the complexity of the perioral musculature and soft tissues. Despite significant advances in free transfers, locoregional flaps remain important in subtotal lip reconstruction, offering better tissue and color adaptation, partial preservation of muscle dynamics, and reduced surgical morbidity.
Reconstruction techniques vary depending on the extent of tissue loss. For defects affecting approximately half of the lip, Abbe or Estlander cross flaps using similar tissue allow functional reinnervation within 6 to 12 months. However, use of these techniques is limited by the risk of microstomia. For more extensive tissue loss (exceeding 50% of the lip), advancement or rotation flaps, such as Gilles, Bernard-Webster, or Karapandzic flaps, are preferred. Finally, tissue loss exceeding 80% or extending beyond the labio-mental sulcus or toward the cheek often requires free tissue transfer, with the risk of impaired lip function and a less than optimal aesthetic result.
Historically, the gold standard technique for lower lip reconstruction is that described by Camille Bernard in 1853, modified by Webster in 1960. Although traditionally considered adynamic due to the sectioning of the perioral muscles, clinical experience suggests that preserving the modiolus and its muscular attachments allows for the maintenance of some tone and mobility in the long term. This structure, the point of convergence of the superficial and deep fascias, plays a key role in lip dynamics by connecting the elevators, depressors, and lateral retractors.
A few studies describe facial reconstruction techniques, with the reference for the lower lip being that described by Camille Bernard in 1853, reviewed by Webster in 1960, but few if any of them focus on the functional and aesthetic results after reconstruction. For example, the retrospective analysis conducted by J. Faulhaber's team reports patient satisfaction in terms of aesthetics and function at the usual follow-up appointment, without substantiating the reasons for this alleged satisfaction. In the study conducted by E. E. Ünsal Tuna et al, a questionnaire was developed to collect functional and aesthetic outcomes from patients, but it was completed by healthcare professionals during a follow-up appointment. The same is true in the prospective study conducted by R. Denadai et al, where although patients are asked about their overall satisfaction with the functional aspect of the reconstruction, it is nevertheless healthcare professionals who more accurately assess the functional results after the reconstruction.
This study therefore focuses on analyzing the post-operative experience of patients, as well as gathering the analysis of doctors and surgeons working on facial issues (plastic surgeons and dermatologists). The aim of the study is to optimize future therapeutic strategies by providing factual information to help decide between the various therapeutic options. It is important to ensure optimal patient care, guaranteeing aesthetic and functional satisfaction, combined with an acceptable quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients over 18 years of age who underwent lower lip reconstruction after excision for skin carcinoma, operated on in Pontoise between January 1, 2014, and October 31, 2025.
Key inclusion criteria (4 listed)
- Patient over 18 years of age.
- Patients who underwent lower lip reconstruction after excision for skin carcinoma, operated on in Pontoise between January 1, 2014, and October 31, 2025.
- Patients who had a post-operative follow-up consultation (± 2 months).
- Patients who were informed and did not object to participating in the study
Key exclusion criteria (3 listed)
- Cognitive impairment preventing completion of the questionnaire.
- Patient under legal protection (guardianship, conservatorship, or judicial protection).
- Patient deceased.
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 |
|---|---|---|
| Patient-Reported Outcome Questionnaire (post-operative)The patient must complete two questionnaires to assess the functional and aesthetic outcomes and quality of life after lower lip reconstruction. No intervention was assigned by the investigator; the surgery was part of routine clinical care. | Other | – |
Primary outcome
Overall patient satisfaction with the functional and aesthetic outcomes of lip reconstruction at 12 months postoperatively, assessed by a self-reported questionnaire.
Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)
On the questionnaire, the patient is asked to rate from 1 to 10, where 1 means "strongly disagree" and 10 means "strongly agree."
5 secondary outcomes
Correlation between overall patient satisfaction and various functional and aesthetic aspects of the face and their impact on daily life.
Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)
Postoperative complications up to one year after surgery
Time frame: Postoperative period from day 0 to one year
Quality of life one year after surgery
Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)
Compare patients' aesthetic perceptions with those of professionals
Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)
Demonstrate a correlation between the aesthetic success of the procedure and the technical complexity of its execution.
Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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.
AL TABAA AL TABAA, Dr principal investigator
Hôpital NOVO - Site Pontoise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Lip Tissue Loss and Cancer, run by Hôpital NOVO at 1 site in France.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline Delattre (0033130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient satisfaction with the functional and aesthetic outcomes of lip reconstruction at 12 months postoperatively, assessed by a self-reported questionnaire. (time frame: 12 months postoperatively (data collected upon return of completed questionnaire)). 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 9 Jun 2026.