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一项评估腹股沟疝修补手术围手术期康复可行性的前瞻性随机对照试验。

A pilot randomized controlled trial examining the feasibility of perioperative rehabilitation for inguinal hernia repair surgery.

作者信息

Shologan Anna, Farooq Omar, Bostick Geoffrey, Macedo Luciana, Durand-Moreau Quentin, Peters Meaghan Ray, Gross Douglas P

机构信息

Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.

Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.

出版信息

PLoS One. 2025 May 22;20(5):e0324907. doi: 10.1371/journal.pone.0324907. eCollection 2025.

Abstract

BACKGROUND

Despite the high frequency of inguinal hernia repair (IHR) surgery, there is little research investigating pre- or post-operative exercise and education in this population. Recommendations regarding perioperative physical activity are inconsistent and largely based on clinical opinion. We conducted a pilot randomized controlled trial to examine the feasibility of perioperative rehabilitation for inguinal hernia repair surgery in terms of recruitment rate, assessment, and protocol implementation.

METHODS

Participants were randomized into an intervention group and control group. Descriptive and patient-reported data were collected through online surveys at baseline, post-prehabilitation (prehab), 1-week post-operative (post-op), and 12-week post-op. Eligible participants completed a performance-based modified Short Form Functional Capacity Evaluation conducted by a masked observer at baseline, after 6 weeks of exercise and/or education, and at 12-week post-op. Participants in the intervention group received 6 weeks of exercise and education prior to and then after surgery. The control group received care as usual.

RESULTS

Thirty-one participants awaiting IHR with a mean age of 49 years were recruited (recruitment rate of 51.7%). Thirty participants were randomized into control (n = 16) and intervention groups (n = 14), while 1 dropped out prior to beginning the study due to being unable to take time off work for assessment. Twenty-four participants completed the final 12-week post-op follow-ups. Twenty-one participants returned to work by the 12-week post-op follow-up. Sixty-seven percent of participants in the intervention group exercised at least 3 times per week post-operatively. One participant in each group experienced exacerbations of hernia symptoms that were unrelated to study activities. Functional testing resulted in minimal symptom exacerbation in either group, but the intervention group reported less pain at 12-week post-op than controls.

CONCLUSION

A randomized trial of perioperative rehabilitation for patients undergoing inguinal hernia repair appears feasible, but protocol adjustments are needed to improve recruitment rate, assessment, and participant retention. Trial Registration: This trial is registered with ClinicalTrials.gov Identifier: NCT05069142.

摘要

背景

尽管腹股沟疝修补术(IHR)手术的频率很高,但针对该人群术前或术后运动及教育的研究却很少。关于围手术期体育活动的建议并不一致,且很大程度上基于临床意见。我们进行了一项初步随机对照试验,以从招募率、评估和方案实施方面检验腹股沟疝修补手术围手术期康复的可行性。

方法

参与者被随机分为干预组和对照组。通过在线调查在基线、术前康复(预康复)、术后1周和术后12周收集描述性和患者报告的数据。符合条件的参与者在基线、运动和/或教育6周后以及术后12周由一名蒙面观察者进行基于表现的改良简短形式功能能力评估。干预组的参与者在手术前后各接受6周的运动和教育。对照组接受常规护理。

结果

招募了31名等待腹股沟疝修补术的参与者,平均年龄49岁(招募率为51.7%)。30名参与者被随机分为对照组(n = 16)和干预组(n = 14),1名参与者在开始研究前因无法请假进行评估而退出。24名参与者完成了最后的术后12周随访。21名参与者在术后12周随访时恢复工作。干预组67%的参与者术后每周至少锻炼3次。每组各有1名参与者出现与研究活动无关的疝症状加重。功能测试在两组中导致的症状加重均最小,但干预组在术后12周报告的疼痛比对照组少。

结论

对接受腹股沟疝修补术的患者进行围手术期康复的随机试验似乎可行,但需要调整方案以提高招募率、评估和参与者留存率。试验注册:本试验已在ClinicalTrials.gov注册,标识符:NCT05069142。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6145/12097709/30c1bb6d8cc3/pone.0324907.g001.jpg

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