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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Hôpital NOVO

    Cergy-Pontoise, 95300

    Veronique DA COSTA, 0033130755069, veronique.dacosta@ght-novo.fr

    Recruiting

Other trials in France

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.

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.

  1. 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)
  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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.

  1. First posted23 Dec 2025
  2. Study start21 Apr 2026
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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)
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

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.

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