Evaluation of Gynecological and Sexual Sequelae

NCT07389863 | Recruiting

• 2 other identifiers: 2025/0441/OB2025-A02592-47
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer Patients

Keywords

Gynecological and sexual sequelae

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• 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

  1 day

Secondary Outcomes (3)

• Identify the main risk factors for gynecological and sexual sequelae in patients

  1 day

• Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients

  1 day

• Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale

  1 day

Study Arms (1)

Prevalence of gynecological and sexual sequelae in women after treatment for rectal cancer

The prevalence and characterization of gynecological and sexual sequelae in women after treatment for rectal cancer will be carried out on the basis of questionnaires under study (FSFI, QLQ-CR29, QLQ-C30 and the GynéRect questionnaire) completed during the single follow-up visit.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Service de Chirurgie Digestive

Rouen, 76031, France

RECRUITING

Study Officials

• Valérie VB BRIDOUX, Professor

  University Rouen Hospital

  STUDY DIRECTOR

• Pauline PL LUDWIG, Doctor junior

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabila NL LAAJAIL, Director

CONTACT

02 32 88 82 65; Secretariat.DRC@chu-rouen.fr

vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; vincent.ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)