Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Phase 4

Completed

• Conditions: Rectal Tumors; Erectile Dysfunction
• Interventions: Other: vacuum erection device

• Registration Number: NCT01912586
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Status Verified: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	vacuum erection device	sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.
Arm C	vacuum erection device	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.

Primary Outcome Measures

Name	Time	Method
Changes in sexual function based on the (IIEF)-5 score and NPT	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 Outcome Measures

Name	Time	Method
Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT	12 months	Summarized according to assigned treatment group.

Trial Locations

Locations (1)

Department of General Surgery, Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China