Rectal CancerMSSPCNCT02728427
Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
A study testing Suprapubic catheterization using central venous catheter(CVC-2 7F) and Transurethral catheterization using Foley catheter in people with Rectal Cancer and Surgery, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial summary
Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- Suprapubic catheterization using central venous catheter(CVC-2 7F) and Transurethral catheterization using Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Pathological rectal carcinoma
- Male patients
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I, II, or III
- Laparoscopic surgery for rectal cancer
- Written informed consent
Who cannot join
- Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer
- Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual
- Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function
- History of previous pelvic surgery
- Severe mental disease
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350-001
Fangqin Xue, M.D., +86-137-9995-9360, xuefangqingsl@sina.com
fangqin xue, M.D.
- Recruiting
Fujian Provincial cancer Hospital
Fuzhou, Fujian, 350-014
Weidong Zang, M.D., +86-13805066578, 894434459@qq.com
Chunkang Yang, M.D., +86-13509333116
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com
Jun Yan, M.D., Ph.D., +86-138-2506-6546, yanjunfudan@163.com
About this study
Official title: Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.
Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.
- Conditions
- Rectal Cancer, Surgery
- Being tested
- Suprapubic catheterization using central venous catheter(CVC-2 7F), Transurethral catheterization using Foley catheter
- Keywords
- Suprapubic Catheterization, Transurethral Catheterization, Rectal Cancer, Laparoscopic Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprapubic catheterization using central venous catheter(CVC-2 7F)Device
Also called SPCCVC
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc.
Transurethral catheterization using Foley catheterDevice
Also called TUC
Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.
| Study group | Role | What they receive |
|---|---|---|
| Suprapubic Catheterization | Experimental | Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group. Receives: Device: Suprapubic catheterization using central venous catheter(CVC-2 7F) |
| Transurethral Catheterization | Active comparator | Transurethral catheterization using Foley catheter will be performed for patients in this group. Receives: Device: Transurethral catheterization using Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catherization time
Measured: 6 days
Secondary outcomes (9)
Number of catheterization
Measured: 30 days
Catheter-Associated Urinary Tract Infection
Measured: 30 days
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool from the surgery day to the fifth day after surgery.
Measured: 5 days
International Prostatic Symptom Score
The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.
Measured: 30 days
Time to first ambulation
Measured: 7 days
Duration of hospital stay
Measured: 30 days
Urinary extravasation
Measured: 30 days
Hematuria
Measured: 30 days
Catheter obstruction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Fujian Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Guoxin Li, M.D., Ph.D., Principal investigator, Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728427
- Sponsor's protocol ID
- SPCCVC-TUC
- Acronym
- MSSPC
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
PubMed 25830422Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. doi: 10.1002/bjs.4989.
PubMed 15997446Maurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Buchler MW. Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5. doi: 10.1046/j.0007-1323.2001.01904.x.
PubMed 11683749Bouchet-Doumenq C, Lefevre JH, Bennis M, Chafai N, Tiret E, Parc Y. Management of postoperative bladder emptying after proctectomy in men for rectal cancer. A retrospective study of 190 consecutive patients. Int J Colorectal Dis. 2016 Mar;31(3):511-8. doi: 10.1007/s00384-015-2471-8. Epub 2015 Dec 22.
PubMed 26694925Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH. Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5. doi: 10.1002/bjs.1800740731.
PubMed 3304522Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW. Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9. doi: 10.1007/s003840050038.
PubMed 8876274Perrin LC, Penfold C, McLeish A. A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6. doi: 10.1111/j.1445-2197.1997.tb02037.x.
PubMed 9287924
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02728427
- Acronym / sponsor ID
- MSSPC / SPCCVC-TUC
- Conditions
- Rectal Cancer, Surgery
- Keywords
- Suprapubic Catheterization, Transurethral Catheterization, Rectal Cancer, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Fujian Provincial Hospital
- Study start
- Apr 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.
Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapubic Catheterization | Experimental | Device: Suprapubic catheterization using central venous catheter(CVC-2 7F)Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group. |
| Transurethral Catheterization | Active comparator | Device: Transurethral catheterization using Foley catheterTransurethral catheterization using Foley catheter will be performed for patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 18 years
- Pathological rectal carcinoma
- Male patients
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I, II, or III
Key exclusion criteria (5 listed)
- Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer
- Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual
- Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function
- History of previous pelvic surgery
- Severe mental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprapubic catheterization using central venous catheter(CVC-2 7F)Also: SPCCVCSuprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc. | Device | Suprapubic Catheterization |
| Transurethral catheterization using Foley catheterAlso: TUCTraditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication. | Device | Transurethral Catheterization |
Primary outcome
Catherization time
Time frame: 6 days
9 secondary outcomes
Number of catheterization
Time frame: 30 days
Catheter-Associated Urinary Tract Infection
Time frame: 30 days
Pain score
Time frame: 5 days
International Prostatic Symptom Score
Time frame: 30 days
Time to first ambulation
Time frame: 7 days
Duration of hospital stay
Time frame: 30 days
Urinary extravasation
Time frame: 30 days
Hematuria
Time frame: 30 days
Catheter obstruction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 25830422Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
- Background: PubMed 15997446Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. doi: 10.1002/bjs.4989.
- Background: PubMed 11683749Maurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Buchler MW. Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5. doi: 10.1046/j.0007-1323.2001.01904.x.
- Background: PubMed 26694925Bouchet-Doumenq C, Lefevre JH, Bennis M, Chafai N, Tiret E, Parc Y. Management of postoperative bladder emptying after proctectomy in men for rectal cancer. A retrospective study of 190 consecutive patients. Int J Colorectal Dis. 2016 Mar;31(3):511-8. doi: 10.1007/s00384-015-2471-8. Epub 2015 Dec 22.
- Background: PubMed 3304522Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH. Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5. doi: 10.1002/bjs.1800740731.
- Background: PubMed 8876274Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW. Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9. doi: 10.1007/s003840050038.
- Background: PubMed 9287924Perrin LC, Penfold C, McLeish A. A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6. doi: 10.1111/j.1445-2197.1997.tb02037.x.
- Southern Medical University, ChinaLink provided by the sponsor.
- Nanfang Hospital, ChinaLink provided by the sponsor.
- Chinese Anti-Cancer AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoxin Li, M.D., Ph.D. principal investigator
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprapubic catheterization using central venous catheter(CVC-2 7F) and Transurethral catheterization using Foley catheter in people with Rectal Cancer and Surgery, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Li, M.D., Ph.D. (+86-138-0277-1450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catherization time (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728427, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.