Evaluation of Gynecological and Sexual Sequelae
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rectal Cancer Patients. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Gynecological and Sexual Sequelae in Patients Treated for Rectal Cancer
Overview
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.
Detailed description
In women, there is a significant link between gynecological clinical abnormalities and the onset of sexual dysfunction. Gynecological anatomical sequelae are a major determinant of female sexual health. However, their assessment in clinical practice in the context of rectal cancer remains inconsistent, incomplete, or delayed. The repercussions of impaired sexual quality of life are also significant from a public health perspective. Good sexual quality of life is directly linked to a better overall quality of life in women over 40. These results could therefore be extrapolated to patients experiencing sexual dysfunction after treatment for rectal cancer. Finally, impaired overall quality of life leads to increased healthcare utilization and disability, with significant socioeconomic repercussions.
Gynecological and sexual sequelae following treatment for rectal cancer are therefore frequent but insufficiently assessed and managed in clinical practice, despite their impact on patients' overall quality of life and on public health. This work would allow for a better understanding of these disorders in order to prevent, assess, and manage them more effectively and thus optimize patients' future quality of life.
Primary outcome measures
- To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. [Time frame: 1 day]
- To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. [Time frame: 1 day]
Secondary outcome measures (3)
- Identify the main risk factors for gynecological and sexual sequelae in patients [Time frame: 1 day]
- Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients [Time frame: 1 day]
- Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Service de Chirurgie Digestive — Rouen
Identifiers
NCT: NCT07389863 · 2025/0441/OB · 2025-A02592-47