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Clinical Trials in France / NCT07389863
Recruiting Observational

Evaluation of Gynecological and Sexual Sequelae

NCT07389863 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Rouen
Phase
Observational
Started
2026-02-09
Last updated
2026-05-05

Condition(s) studied

Rectal Cancer Patients

Study summary

Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on the tumor's immunohistochemical status.

This treatment strategy has improved recurrence-free survival but is associated with long-term functional complications affecting the digestive, urological, gynecological, and sexual systems. Surgery causes anatomical changes and damage to the autonomic nervous system plexuses. Radiotherapy, for its part, causes pelvic inflammation with the development of fibrosis and potential vascular and nerve damage.

Various disorders can arise as a result of these anatomical changes, such as erectile dysfunction in men; dyspareunia and vaginal dryness in women; urinary incontinence and impaired sexual quality of life in both sexes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged 18 to 60 at the time of diagnosis * Having been treated for rectal cancer between 2020 and 2025 * Cancer in remission * Having been sexually active before receiving treatment for their rectal cancer * Having completed the various questionnaires during their treatment Exclusion Criteria: * Inability to complete questionnaires (cognitive impairment, language barrier) * Pregnant women * Women with active cancer and/or undergoing chemotherapy * Women with a history of extensive gynecological surgery * Individuals deprived of their liberty by an administrative or judicial decision, or individuals under legal protection/guardianship or curatorship * Individuals without social security coverage

Primary outcome measure(s)

  • To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. — 1 day
    Evaluation of the prevalence of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders
  • To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. — 1 day
    Evaluation of the description of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders

Trial sites (1)

FacilityCityRegionStatus
Service de Chirurgie Digestive Rouen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07389863 on ClinicalTrials.gov ↗ ← All trials in France