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Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Primary Purpose

Rectal Tumors, Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
vacuum erection device
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Tumors focused on measuring erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Patients receive no interventions for ED after laparoscopic surgery

sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2013
Last Updated
June 17, 2015
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01912586
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Tumors, Erectile Dysfunction
Keywords
erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
No Intervention
Arm Description
Patients receive no interventions for ED after laparoscopic surgery
Arm Title
Arm B
Arm Type
Experimental
Arm Description
sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.
Arm Title
Arm C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
vacuum erection device
Other Intervention Name(s)
sildenafil
Intervention Description
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Primary Outcome Measure Information:
Title
Changes in sexual function based on the (IIEF)-5 score and NPT
Description
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).
Time Frame
3 months
Title
Changes in sexual function based on the (IIEF)-5 score and NPT
Description
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).
Time Frame
6 months
Title
Changes in sexual function based on the (IIEF)-5 score and NPT
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT
Description
Summarized according to assigned treatment group.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of General Surgery, Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22010127
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.
Results Reference
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PubMed Identifier
22476834
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.
Results Reference
background
PubMed Identifier
21135876
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.
Results Reference
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Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

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