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腹腔镜腹股沟疝修补术后导尿管使用对术后尿潴留的影响:一项随机临床试验。

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

机构信息

Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Center for Abdominal Core Health, The Cleveland Clinic Foundation, Cleveland, Ohio.

Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Florida, Weston Hospital, Weston.

出版信息

JAMA Surg. 2022 Aug 1;157(8):667-674. doi: 10.1001/jamasurg.2022.2205.

DOI:10.1001/jamasurg.2022.2205
PMID:35704302
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9201739/
Abstract

IMPORTANCE

Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking.

OBJECTIVE

To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair.

DESIGN, SETTING, AND PARTICIPANTS: This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention.

INTERVENTIONS

Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement.

MAIN OUTCOMES AND MEASURES

PUR rate.

RESULTS

Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement.

CONCLUSIONS AND RELEVANCE

Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03835351.

摘要

重要性

在腹腔镜腹股沟疝修补术中,通常会放置导尿管,以预防术后尿潴留(PUR),这是该手术最常见的并发症之一。但缺乏评估导管对 PUR 影响的随机临床试验数据。

目的

研究腹腔镜腹股沟疝修补术中放置导尿管对 PUR 的影响。

设计、地点和参与者:这是一项在美国 6 家学术和社区医院进行的、基于 2 臂的、单盲、随机临床试验,从 2019 年 3 月至 2021 年 3 月进行,术后随访 30 天。所有患有腹股沟疝的患者均进行了资格评估,共 534 例。纳入标准为接受腹腔镜、择期、单侧或双侧腹股沟疝修补术的成年患者。排除标准为无法耐受全身麻醉以及无法理解和签署书面知情同意书。在干预前,共有 43 例患者被排除。

干预措施

治疗组患者在全身麻醉诱导后和手术结束时放置导尿管,对照组患者不放置导尿管。

主要结局和测量指标

PUR 发生率。

结果

共纳入 491 例患者,241 例随机分至导管放置组,250 例随机分至无导管放置组。患者的中位(IQR)年龄为 61(51-68)岁,465 例(94.7%)为男性。共有 44 例(9.1%)患者发生 PUR。导管组和无导管组的 PUR 发生率无差异(分别为 23 例[9.6%]和 21 例[8.5%];P = .79)。术中未发生膀胱损伤。在导管组中,1 例患者因 PUR 就诊于急诊部,并发尿道创伤,随后行耻骨上导尿。

结论和相关性

腹腔镜腹股沟疝修补术中放置导尿管不能降低 PUR 的风险。虽然导尿管的使用似乎与较高的医源性并发症发生率无关,但可能存在较低的灾难性并发症发生率。对于术前能排尿的患者,放置导尿管似乎没有任何优势,因此可考虑重新评估其使用。

试验注册

ClinicalTrials.gov 标识符:NCT03835351。