Functional and Aesthetic Outcomes Following Lower Lip Reconstruction (REFEPLI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Lower Lip Tissue Loss
• Intervention / Treatment: Other: Patient-Reported Outcome Questionnaire (post-operative)

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Maryline Delattre; Phone Number: 0033130754131; Email: maryline.delattre@ght-novo.fr
• Study Contact Backup: Name: Véronique Da Costa; Phone Number: 0033130755069; Email: veronique.dacosta@ght-novo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	12 months postoperatively (data collected upon return of completed questionnaire)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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.	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	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	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	12 months postoperatively (data collected upon return of completed questionnaire)

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: AL TABAA AL TABAA, Dr, Hôpital NOVO - Site PONTOISE

Study record dates

Study Major Dates

• Study Start (Estimated): January 12, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Post-operative; Aesthetic and functional outcomes after lower lip reconstruction; Patient-reported outcome questionnaire; Aesthetic and functional satisfaction; Optimal patient care; Analysis of physicians and surgeons working on topics related to the face
• Additional Relevant MeSH Terms: Neoplasms; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Perioperative Period; Postoperative Period
• Other Study ID Numbers: CHRD1425; 2025-A01933-46 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No