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Completed

NCT Number: NCT02922647

Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males

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.

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Key information

Conditions

Infection Cancer Infections Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

suprapubic catheterization

Device

Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males

transurethral catheterization

Device

Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra

    Time frame: at 1, 2, 3 and 4 days

    visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )

  3. Participants morbidity and mortality as assessed by Dindo and Clavien classification

    Time frame: at 1 month and 6 months

  4. Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L

    Time frame: at 30 days and 6 months

    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.

  5. 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

    Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions.

  6. Duration of hospital stay in days

    Time frame: within 6 months

    the hospital stay by day

  7. Rate of recatheterization

    Time frame: in the first 6 months

  8. Duration of postoperative return to normal bladder function as assessed by IPSS score

    Time frame: at 1 and 6 months

  9. Number of additionnal consultations

    Time frame: in the first 6 months

  10. 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

    visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )

  11. Specific complications

    Time frame: in the first 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: GRECCAR10

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Oct 4, 2016
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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