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NCT Number: NCT07298070

Functional and Aesthetic Outcomes Following Lower Lip Reconstruction

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Cognitive impairment preventing completion of the questionnaire.
  • Patient under legal protection (guardianship, conservatorship, or judicial protection).
  • Patient deceased.

Treatment and study plan

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.

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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)

    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."

  2. Postoperative complications up to one year after surgery

    Time frame: Postoperative period from day 0 to one year

    Postoperative complications lasting up to one year, including nonunion, the need for revision surgery, and in particular commissuroplasty.

  3. Quality of life one year after surgery

    Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)

    Quality of Life Questionnaire: University of Washington Quality of Life Questionnaire

  4. Compare patients' aesthetic perceptions with those of professionals

    Time frame: 12 months postoperatively (data collected upon return of completed questionnaire)

    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

  5. 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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Maryline Delattre

CONTACT

[email protected]

0033130754131

Véronique Da Costa

CONTACT

[email protected]

0033130755069

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: REFEPLI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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