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Completed

NCT Number: NCT01912586

Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Although the high prevalence of erectile dysfunction (ED) was detected among male patients after the treatment for colorectal cancer, published reports depicting the erectile dysfunction experience of patients with colorectal cancer ot underpin service development are insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer are not routinely offered information and treatment for erectile dysfunction.However, investigations on patients after surgery for prostate cancer could provide some potentially useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the return of erections after nerve-sparing radical prostatectomy has been established, which may benefit rectal cancer patients after surgery with ED.

Laparoscopic surgery, although technically demanding and associated with a long learning curve, has the advantage of clear visualization for the smallest structures,including the autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation of the pelvic autonomic nerves.

This study aimed to identify whether early intervention is effective at reducing the rate of ED at 12 months.

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Key information

Conditions

Rectal Tumors Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Erectile Dysfunction Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of General Surgery, Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 < Age < 70
  • Sexually active men without the consistent use of erectile aids pre-operatively
  • Rectal cancer confirmed by histology
  • Undergoing a bilateral nerve sparing laparoscopic rectal resection
  • IIEF-5 domain score > =20 before surgery
  • Presence of a female sexual partner
  • Willingness to participate in clinical research as evidenced by their signature on the informed consent form

Exclusion criteria

  • Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months
  • Has taken or has been prescribed nitrate medication in any form in the last 6 months
  • Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
  • Contraindication to vacuum erection device (e.g. coagulation abnormality, stick cell disease)
  • Men with a history of known penile deformity or Peyronie's disease
  • Pre or postoperative androgen therapy

Treatment and study plan

vacuum erection device

Other

sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months

Other names: sildenafil

Primary outcomes

  1. Changes in sexual function based on the (IIEF)-5 score and NPT

    Time frame: 3 months

    Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT).

  2. Changes in sexual function based on the (IIEF)-5 score and NPT

    Time frame: 6 months

    Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT).

  3. Changes in sexual function based on the (IIEF)-5 score and NPT

    Time frame: 12 months

    Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT).

Secondary outcomes

  1. Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT

    Time frame: 12 months

    Summarized according to assigned treatment group.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 31, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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