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Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention (RectSexQol)

U

University of Limoges (UL)

Status

Enrolling

Conditions

Sexuality
Life Quality
Women
Rectal Tumor

Treatments

Other: standart of care
Other: sexologist consult

Study type

Interventional

Funder types

Other

Identifiers

NCT05933122
87RI22_0006

Details and patient eligibility

About

RectSexQoL is a study aiming at determining the prevalence of female sexual dysfunction after rectal cancer surgery. It has the goal as well to analyse the impact of an intervention given by a sexologist to such patients.

Full description

The treatment of rectal cancer is multimodal combining surgery, chemotherapy and radiotherapy. Each therapeutic tool may affect the sexual life of treated patients.

The incidence of sexual dysfunction in patients with rectal cancer varies according to literature from 5 to 88%. This may be due to the lack of a common definition relating to sexual dysfunction making it difficult to compare results. On the other hand, it should be noted that all of the work related to sexual dysfunction after treatment for rectal cancer is mainly interested in men. The sexual well-being of women treated for rectal cancer is based on the assessment and management of their sexual functions as well as that of their overall sexual health in a personalized manner. The establishment of a sexology consultation before and after such a surgical procedure could improve the sexual functions as well as the sexual well-being of these women. The main aim of our study is to evaluate the prevalence of sexual dysfunctions at M-1 (before treatment) in the two cohorts "here" and "elsewhere" in the context of surgery for rectal cancer in females. The second aim will be to determine the impact of sexology consultation in the cohort "here" in comparison to the standart cohort without any intervention called "elsewhere".

Enrollment

144 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women
  • Diagnosis of stage I-III rectal adenocarcinoma or rectosigmoid junction with anastomosis less than 15 cm from the anal margin
  • Surgical management, preceded or not by Radio-chemotherapy, with restoration of continuity
  • Age : over 18
  • Proficiency in French or English

Exclusion criteria

  • Current pregnancy
  • Significant cognitive/psychiatric disorders
  • Guardianship

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

144 participants in 2 patient groups

Cohort called "elsewhere"
Sham Comparator group
Description:
cohort without specific care by a sexologist
Treatment:
Other: standart of care
Cohort called "here"
Experimental group
Description:
cohort with an intervention by a sexologist
Treatment:
Other: sexologist consult

Trial contacts and locations

6

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Central trial contact

Niki Christou, MD

Data sourced from clinicaltrials.gov

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