Clinical trial NCT01912586: Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer
Official title: A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rectal Tumors
Erectile Dysfunction
Keywords: erectile dysfunction
laparoscopic surgery
rectal cancer
sildenafil
vacuum erection device
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in sexual function based on the (IIEF)-5 score and NPT
timeFrame: 3 months
measure: Changes in sexual function based on the (IIEF)-5 score and NPT
timeFrame: 6 months
measure: Changes in sexual function based on the (IIEF)-5 score and NPT
timeFrame: 12 months
Secondary outcomes:
measure: Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of General Surgery, Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
citation: 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.
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.
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.