InfectionGRECCAR10NCT02922647
Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
A study testing suprapubic catheterization and transurethral catheterization in people with Infection and Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- suprapubic catheterization and transurethral catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2016to 16 Apr 2021
- 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
- Male patients of at least 18 years of age
- Histologically proven rectal adenocarcinoma
- Stage T1-4 Nx Mx
- With or without neoadjuvant treatment
- TME and low anastomosis (colorectal or coloanal, stapled or handsewn)
- With or without loop ileostomy
- Open or laparoscopic approach
- Patient and doctor have signed a study specific informed consent form
Who cannot join
- Colonic and upper third rectal cancer (No or Partial Mesorectal Excision)
- Abdominoperineal resection
- Associated prostate, and/or seminal glands and/or bladder resection
- Infected tumour, Emergency surgery
- Epidural analgesia
- Patient with antibiotic therapy (other than prophylaxis)
Show all 12Show fewer
- Previous treated/untreated known prostate or bladder carcinoma
- Patient with symptomatic preoperative voiding dysfunction (IPSS score >19)
- Medical history of bladder catheterization for obstruction, or urethral surgery
- Patient necessitating urinary output monitoring (impaired renal function etc)
- Patient deprived of liberty or under guardianship or incapable of giving consent
- Against the usual indications of suprapubic drainage and / or urethral sounding any known allergies to medical device materials. (p. ex. latex) and in general the known allergies to sterilizing agents (particularly oxide ethylene and its derivatives.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38000
About this study
The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.
- Being tested
- suprapubic catheterization, transurethral catheterization
- Medical subject headings
- Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprapubic catheterizationDevice
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
transurethral catheterizationDevice
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
| Study group | Role | What they receive |
|---|---|---|
| suprapubic catheterization | Experimental | Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. Receives: Device: suprapubic catheterization |
| transurethral catheterization | Active comparator | Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. Receives: Device: transurethral catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
The urinary tract infection, defined as significant bacteriuria ( > 104 CFU / mL) and pyuria (> 6 white blood cells per high power field) in urine samples obtained immediately after removal of the urethral catheter or clamping suprapubic catheter and removing the fourth postoperative day.
Measured: four days postoperative
Secondary outcomes (11)
Duration of catherism as assessed by the number of days for participants with the catheter and number of participants leaving the hospital with the catheter
Measured: 1 month
Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
Measured: at 1, 2, 3 and 4 days
Participants morbidity and mortality as assessed by Dindo and Clavien classification
Measured: at 1 month and 6 months
Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L
Patient satisfaction : very, or moderately dissatisfied , unchanged , slightly , moderately , or very disappointed at the exit of the Fact- C hospital and EQ-5D - 3L at 30 days and 6 months.
Measured: at 30 days and 6 months
Cost as assessed by the addition of the costs of the full process depending on the catheterism duration and additional consultations and readmissions for complications
Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions.
Measured: at 6 months
Duration of hospital stay in days
the hospital stay by day
Measured: within 6 months
Rate of recatheterization
Measured: in the first 6 months
Duration of postoperative return to normal bladder function as assessed by IPSS score
Measured: at 1 and 6 months
Number of additionnal consultations
Measured: in the first 6 months
Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
Measured: at 1, 2, 3 and 4 days
Specific complications
Measured: in the first 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start14 Oct 2016
- Primary completion18 May 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Jean Luc FAUCHERON, Principal investigator, University Clinic of Digestive Surgery and Emergency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922647
- Sponsor's protocol ID
- 38RC14.457
- Acronym
- GRECCAR10
- Status last verified
- Jul 2022
- First submitted
- 4 Feb 2016
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah EF, Huddy SP. A prospective study of genito-urinary dysfunction after surgery for colorectal cancer. Colorectal Dis. 2001 Mar;3(2):122-5. doi: 10.1046/j.1463-1318.2001.00221.x.
PubMed 12791005Sterk P, Shekarriz B, Gunter S, Nolde J, Keller R, Bruch HP, Shekarriz H. Voiding and sexual dysfunction after deep rectal resection and total mesorectal excision: prospective study on 52 patients. Int J Colorectal Dis. 2005 Sep;20(5):423-7. doi: 10.1007/s00384-004-0711-4. Epub 2005 Apr 22.
PubMed 15846498Branagan GW, Moran BJ. Published evidence favors the use of suprapubic catheters in pelvic colorectal surgery. Dis Colon Rectum. 2002 Aug;45(8):1104-8. doi: 10.1007/s10350-004-6368-9.
PubMed 12195198Lee SY, Kang SB, Kim DW, Oh HK, Ihn MH. Risk factors and preventive measures for acute urinary retention after rectal cancer surgery. World J Surg. 2015 Jan;39(1):275-82. doi: 10.1007/s00268-014-2767-9.
PubMed 25189452Platt R, Polk BF, Murdock B, Rosner B. Mortality associated with nosocomial urinary-tract infection. N Engl J Med. 1982 Sep 9;307(11):637-42. doi: 10.1056/NEJM198209093071101.
PubMed 7110215Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc.
PubMed 22691687Rasmussen OV, Korner B, Moller-Sorensen P, Kronborg O. Suprapubic versus urethral bladder drainage following surgery for rectal cancer. Acta Chir Scand. 1977;143(6):371-4. No abstract available.
PubMed 605738Shapiro J, Hoffmann J, Jersky J. A comparison of suprapubic and transurethral drainage for postoperative urinary retention in general surgical patients. Acta Chir Scand. 1982;148(4):323-7.
PubMed 7136436Sethia 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 3304522Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French.
PubMed 1938446O'Kelly TJ, Mathew A, Ross S, Munro A. Optimum method for urinary drainage in major abdominal surgery: a prospective randomized trial of suprapubic versus urethral catheterization. Br J Surg. 1995 Oct;82(10):1367-8. doi: 10.1002/bjs.1800821024.
PubMed 7489167Ratnaval 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 9287924Baan AH, Vermeulen H, van der Meulen J, Bossuyt P, Olszyna D, Gouma DJ. The effect of suprapubic catheterization versus transurethral catheterization after abdominal surgery on urinary tract infection: a randomized controlled trial. Dig Surg. 2003;20(4):290-5. doi: 10.1159/000071693. Epub 2003 Jun 5.
PubMed 12789024McPhail MJ, Abu-Hilal M, Johnson CD. A meta-analysis comparing suprapubic and transurethral catheterization for bladder drainage after abdominal surgery. Br J Surg. 2006 Sep;93(9):1038-44. doi: 10.1002/bjs.5424.
PubMed 16804872
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
- ClinicalTrials.gov ID
- NCT02922647
- Acronym / sponsor ID
- GRECCAR10 / 38RC14.457
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Oct 2016
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 4 Oct 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.
The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suprapubic catheterization | Experimental | Device: suprapubic catheterizationIntervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. |
| transurethral catheterization | Active comparator | Device: transurethral catheterizationIntervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male patients of at least 18 years of age
- Histologically proven rectal adenocarcinoma
- Stage T1-4 Nx Mx
- With or without neoadjuvant treatment
- TME and low anastomosis (colorectal or coloanal, stapled or handsewn)
Key exclusion criteria (12 listed)
- Colonic and upper third rectal cancer (No or Partial Mesorectal Excision)
- Abdominoperineal resection
- Associated prostate, and/or seminal glands and/or bladder resection
- Infected tumour, Emergency surgery
- Epidural analgesia
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 catheterizationExperimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males | Device | suprapubic catheterization |
| transurethral catheterizationActive comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males | Device | transurethral catheterization |
Primary outcome
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
Time frame: four days postoperative
The urinary tract infection, defined as significant bacteriuria ( > 104 CFU / mL) and pyuria (> 6 white blood cells per high power field) in urine samples obtained immediately after removal of the urethral catheter or clamping suprapubic catheter and removing the fourth postoperative day.
11 secondary outcomes
Duration of catherism as assessed by the number of days for participants with the catheter and number of participants leaving the hospital with the catheter
Time frame: 1 month
Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
Time frame: at 1, 2, 3 and 4 days
Participants morbidity and mortality as assessed by Dindo and Clavien classification
Time frame: at 1 month and 6 months
Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L
Time frame: at 30 days and 6 months
Cost as assessed by the addition of the costs of the full process depending on the catheterism duration and additional consultations and readmissions for complications
Time frame: at 6 months
Duration of hospital stay in days
Time frame: within 6 months
Rate of recatheterization
Time frame: in the first 6 months
Duration of postoperative return to normal bladder function as assessed by IPSS score
Time frame: at 1 and 6 months
Number of additionnal consultations
Time frame: in the first 6 months
Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
Time frame: at 1, 2, 3 and 4 days
Specific complications
Time frame: in the first 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 12791005Shah EF, Huddy SP. A prospective study of genito-urinary dysfunction after surgery for colorectal cancer. Colorectal Dis. 2001 Mar;3(2):122-5. doi: 10.1046/j.1463-1318.2001.00221.x.
- Background: PubMed 15846498Sterk P, Shekarriz B, Gunter S, Nolde J, Keller R, Bruch HP, Shekarriz H. Voiding and sexual dysfunction after deep rectal resection and total mesorectal excision: prospective study on 52 patients. Int J Colorectal Dis. 2005 Sep;20(5):423-7. doi: 10.1007/s00384-004-0711-4. Epub 2005 Apr 22.
- Background: PubMed 12195198Branagan GW, Moran BJ. Published evidence favors the use of suprapubic catheters in pelvic colorectal surgery. Dis Colon Rectum. 2002 Aug;45(8):1104-8. doi: 10.1007/s10350-004-6368-9.
- Background: PubMed 25189452Lee SY, Kang SB, Kim DW, Oh HK, Ihn MH. Risk factors and preventive measures for acute urinary retention after rectal cancer surgery. World J Surg. 2015 Jan;39(1):275-82. doi: 10.1007/s00268-014-2767-9.
- Background: PubMed 7110215Platt R, Polk BF, Murdock B, Rosner B. Mortality associated with nosocomial urinary-tract infection. N Engl J Med. 1982 Sep 9;307(11):637-42. doi: 10.1056/NEJM198209093071101.
- Background: PubMed 22691687Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc.
- Background: PubMed 605738Rasmussen OV, Korner B, Moller-Sorensen P, Kronborg O. Suprapubic versus urethral bladder drainage following surgery for rectal cancer. Acta Chir Scand. 1977;143(6):371-4. No abstract available.
- Background: PubMed 7136436Shapiro J, Hoffmann J, Jersky J. A comparison of suprapubic and transurethral drainage for postoperative urinary retention in general surgical patients. Acta Chir Scand. 1982;148(4):323-7.
- 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 1938446Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French.
- Background: PubMed 7489167O'Kelly TJ, Mathew A, Ross S, Munro A. Optimum method for urinary drainage in major abdominal surgery: a prospective randomized trial of suprapubic versus urethral catheterization. Br J Surg. 1995 Oct;82(10):1367-8. doi: 10.1002/bjs.1800821024.
- 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.
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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.
Pr Jean Luc FAUCHERON principal investigator
University Clinic of Digestive Surgery and Emergency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprapubic catheterization and transurethral catheterization in people with Infection and Cancer, run by University Hospital, Grenoble at 1 site in France.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria (time frame: four days postoperative). 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 NCT02922647, which also lists 18 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 21 Jul 2022.