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临床试验/NCT04434378
NCT04434378终止4 期

The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study

Jewish Hospital, Cincinnati, Ohio1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2017年11月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
170
试验地点
1
主要终点
Incidence of postoperative urinary retention.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • History of neurogenic bladder requiring routine intermittent catheterization
  • Emergent laparoscopic hernia repair.
  • 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.
  • Pregnant women.

研究组 & 干预措施

Placebo

Placebo Comparator

Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.

干预措施: Placebo (Drug)

Interventional

Experimental

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.

干预措施: Tamsulosin (Drug)

结局指标

主要结局

Incidence of postoperative urinary retention.

时间窗: 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).

次要结局

  • Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.(within 24 hours of surgery)

研究者

发起方
Jewish Hospital, Cincinnati, Ohio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Caparelli

Resident

Jewish Hospital, Cincinnati, Ohio

研究点 (1)

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