Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

June 17, 2015 updated by: Haijun Deng, MD, PhD, Nanfang Hospital of Southern Medical University

A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Department of General Surgery, Nanfang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 18 < Age < 70
  2. Sexually active men without the consistent use of erectile aids pre-operatively
  3. Rectal cancer confirmed by histology
  4. Undergoing a bilateral nerve sparing laparoscopic rectal resection
  5. IIEF-5 domain score > =20 before surgery
  6. Presence of a female sexual partner
  7. Willingness to participate in clinical research as evidenced by their signature on the informed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm A
Patients receive no interventions for ED after laparoscopic surgery
Experimental: Arm B
sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.
Other: vacuum erection device
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Other Names:
  • sildenafil
Experimental: Arm C
sildenafil 25mg/day nightly and together with using vacuum erection device to make erections for 10-15 minutes/day for 3 months after surgery within one or two weeks.
Other: vacuum erection device
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Other Names:
  • sildenafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months
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).
6 months
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanFang2013035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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