NCT07298070

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026May 2027

First Submitted

Initial submission to the registry

December 11, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 11, 2025

Last Update Submit

December 29, 2025

Conditions

Lower Lip Tissue LossCancer

Keywords

Aesthetic and functional outcomes after lower lip reconstructionPatient-reported outcome questionnairePost-operativeAesthetic and functional satisfactionQuality of lifeOptimal patient careAnalysis of physicians and surgeons working on topics related to the face

Outcome Measures

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.

    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 Outcomes (5)

  • Correlation between overall patient satisfaction and various functional and aesthetic aspects of the face and their impact on daily life.

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

  • Postoperative complications up to one year after surgery

    Postoperative period from day 0 to one year

  • Quality of life one year after surgery

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

  • Compare patients' aesthetic perceptions with those of professionals

    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.

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

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • AL TABAA AL TABAA, Dr

    Hôpital NOVO - Site Pontoise

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline Delattre

CONTACT

0033130754131maryline.delattre@ght-novo.fr

Véronique Da Costa

CONTACT

0033130755069veronique.dacosta@ght-novo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 23, 2025

Study Start

January 12, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12