Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912586
• Other study ID #: NanFang2013035
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2013
• Last updated: June 17, 2015
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Erectile Dysfunction
• Rectal Tumors

Intervention

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

Locations

Country	Name	City	State
China	Department of General Surgery, Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Dowswell G, Ismail T, Greenfield S, Clifford S, Hancock B, Wilson S. Men's experience of erectile dysfunction after treatment for colorectal cancer: qualitative interview study. BMJ. 2011 Oct 18;343:d5824. doi: 10.1136/bmj.d5824. — View Citation

Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7. Review. — View Citation

McGlone ER, Khan O, Flashman K, Khan J, Parvaiz A. Urogenital function following laparoscopic and open rectal cancer resection: a comparative study. Surg Endosc. 2012 Sep;26(9):2559-65. doi: 10.1007/s00464-012-2232-5. Epub 2012 Apr 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sexual function based on the (IIEF)-5 score and NPT	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	No
Primary	Changes in sexual function based on the (IIEF)-5 score and NPT	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	No
Primary	Changes in sexual function based on the (IIEF)-5 score and NPT	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	No
Secondary	Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT	Summarized according to assigned treatment group.	12 months	No