Evaluation of Gynecological and Sexual Sequelae
ConditionRectal Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity Hospital, Rouen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients undergoing treatment for rectal cancer benefit from regular follow-up consultations with the digestive surgeon, allowing for the estimation of the prevalence and characteristics of sexual dysfunctions and gynecological sequelae through questionnaires.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 1 trial groupGroup A: Prevalence of gynecological and sexual sequelae in women after treatment for rectal cancer
Trial outcomes
Primary outcomes
1
To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
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
Time frame
1 day2
To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
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
Time frame
1 daySecondary outcomes
1
Identify the main risk factors for gynecological and sexual sequelae in patients
The number of patients presenting the following risk factors will be assessed: menopausal status, treatment received (surgery alone, pre-operative radio-chemotherapy), surgical technique, tumor location, pelvic nerve involvement based on the medical data available in the computerized patient file and during questioning during a follow-up visit with the surgeon
Time frame
1 day2
Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients
However, to date, no validated questionnaire exists that allows for the precise and phenotypic assessment of sexual and gynecological sequelae after treatment for rectal cancer. For this reason, we propose the GynéRect questionnaire in this study.
Time frame
1 day3
Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale
The criterion will be evaluated using the following questionnaires.The FSFI (Female Sexual Function Index) is an internationally validated self-administered questionnaire that assesses sexual function in women, including patients with a history of cancer. It consists of 19 questions evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Sexual dysfunction is defined as a score of 26.55 or higher on a scale of 36. Patients with an FSFI score ≥ 26.55 are therefore considered to have impaired sexual function. The QLQ-C30 questionnaire assesses health-related quality of life in cancer patients. It is an international standard and is recommended in most cancer clinical trials. The QLQ-CR29 questionnaire complements the QLQ-C30 by focusing on symptoms specifically related to rectal cancer, including bowel, urinary, and sexual dysfunction.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov