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Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434378
Recruitment Status : Terminated (Significant difference not reached on interim analysis)
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Caparelli, Jewish Hospital, Cincinnati, Ohio

Tracking Information
First Submitted Date  ICMJE June 12, 2020
First Posted Date  ICMJE June 16, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE November 16, 2017
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
Incidence of postoperative urinary retention. [ Time Frame: Within 24 hours of surgery ]
Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. [ Time Frame: within 24 hours of surgery ]
Retrospective chart review will be utilized to asses the incidence of risk factors of postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. Risk factors including age >60, total IV fluids, length of procedure, opioid use, bilateral vs unilateral repair, BMI >30, diabetes mellitus, coronary artery disease, and benign prostatic hyperplasia will be assessed. These risk factors will then undergo statistical analysis to determine if they are associated with postoperative urinary retention.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair
Official Title  ICMJE The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study
Brief Summary To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.
Detailed Description

Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented in the office by the attending physician. An order will be placed during surgery scheduling for tamsulosin with instruction to administer one dose in the preoperative holding area on the day of surgery. The Jewish hospital pharmacy will be responsible for providing randomization and placebo medications for double blinding effect. PUR will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to have a confirmed negative urine or serum pregnancy test prior to surgery. This will be completed on arrival to the preoperative holding area.

To detect the difference between the treated group and control group with a significant alpha (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated using the Pearson Chi-square test for Two proportions.

This study will be conducted in the hospital setting at a single institution. Patients will be consented for the study in the pre-admission holding area and followed until discharged from the post anesthesia care unit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
One group will be randomized to tamsulosin and the second group randomized to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post Operative Urinary Retention
Intervention  ICMJE
  • Drug: Tamsulosin
    0.4 mg tamsulosin will be given to a randomized group of patients
  • Drug: Placebo
    placebo will be given to a randomized group of patients
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.
    Intervention: Drug: Placebo
  • Experimental: Interventional
    Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery.
    Intervention: Drug: Tamsulosin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 15, 2020)
170
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 5, 2020
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or bilateral.
  2. ≥18 years of age.
  3. Patients must leave the operating room without at indwelling urinary catheter.

Exclusion Criteria:

  1. History of neurogenic bladder requiring routine intermittent catheterization
  2. Emergent laparoscopic hernia repair.
  3. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g. nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling urinary catheter in the postoperative period.
  4. Pregnant women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04434378
Other Study ID Numbers  ICMJE 17-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Caparelli, Jewish Hospital, Cincinnati, Ohio
Study Sponsor  ICMJE Jewish Hospital, Cincinnati, Ohio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jewish Hospital, Cincinnati, Ohio
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP