Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions

Completed

• Conditions: Sexual Dysfunction; Rectal Surgery; Patient Satisfaction

• Registration Number: NCT05010486
• Lead Sponsor: Université de Sherbrooke

Brief Summary

Sexual dysfunction after rectal surgery varies widely in the literature. Prevalence of sexual dysfunction before surgery and desire of patient to treat this condition is also not well established.

Objectives of this prospective cohort study were to determine prevalence of sexual dysfunction with a questionnaire before and after surgery. Patient's satisfaction and quality of life were also collected regarding preoperative information given.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Male between 18 and 65 years old

• Will undergo one of the following surgeries in the 12 months after the initial visit:

  • Low anterior resection
  • Abdominoperineal resection with end colostomy
  • Total proctocolectomy with ileostomy
  • Total proctocolectomy with ileoanal reservoir
  • Proctectomy

• Having had a sexual intercourse in the 4 weeks prior to the initial visit

• Having the desire to maintain sexual activities in the post-operative period

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Exclusion Criteria

• Tadalafil allergy/hypersensitivity
• Having received treatment for erectile dysfunction or medical treatment in the 4 weeks prior to the initial visit
• Active consumption of nitrate derivatives (NO)
• History of non-arteritic ischemic optic neuropathy
• Severe renal or hepatic insufficiency
• Stroke in the last 6 months
• Myocardial infarction in the last 3 months
• Unstable angina pectoris or angina pectoris during sexual relations
• Cardiac insufficiency Class ≥ 2 in the last 6 months
• Uncontrolled arrhythmia, hypotension or hypertension

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sexual dysfunction after rectal surgery	3 years	Prevalence of sexual dysfunction will be determined with a validated questionnaire on erectile dysfunction (ED). The International Index of Erectile Dysfunction-5 (IIEF-5) focuses on ED; therefore, it only includes the first 5 questions of the IIEF-15. Each item is scored on a 5-point Likert-type ascending scale with a total score between 1 and 25, where a score of 22 and above corresponds to normal erectile function.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	3 years	Patient satisfaction regarding pre-operative information about the possible side-effects of surgery was assessed with a phone call 1 month after surgery. The quality of the information and the importance given to the possible side-effects of surgery, such as ED, were measured according to the patients' perspective on a 1 to 5 Likert-type ascending scale and a "yes or no" type of response.
Sexual dysfunction and quality of life	3 years	Quality of life was measured by the Quality of Life Enjoyment and Satisfaction (LES) Questionnaire Short Form (Q-LES-Q-SF), a 16-item derivative from the Q-LES-Q, a 93-item questionnaire. Patients' satisfaction was evaluated by a 5-point Likert-type ascending scale. The first 14 questions were scored from 14 to 70 points in total, while the last two items addressing medication and overall quality of life were represented by two independent scores of 5 points. Q-LES-Q-SF scores were measured at baseline during the first clinical visit as well as 1 month, 6 months, and 12 months after the surgery.