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临床试验/NCT05867134
NCT05867134招募中不适用

Activity Restrictions After Inguinal Hernia Repair

VA Eastern Colorado Health Care System1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Physiological parameter- Hernia recurrence

研究概览

简要总结

This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.

详细描述

This study will evaluate lifting restrictions in the postoperative period after inguinal hernia repair. Patients will be consented to the study via in person and electronic methods. Patients will be asked to answer a questionnaire regarding their current pre-operative activity levels in order to establish a baseline. Patients will undergo surgery according to normal medical recommendations and patient preference. Patients will be randomized into one of two groups: a control group told to practice standard of care at Eastern Colorado VA with return to activity precautions (6 weeks for open surgery, 2 weeks for minimally invasive surgery) and a treatment group told to "return to activity as tolerated/comfortable and stop activity if pain present". Patients will be observed in post-operative clinics and asked clinical questions, as well as questionnaires to assess their surgical experience, when they returned to activity, and overall quality of life. Medical charts will be reviewed in order to compare differences in responses and behaviors between the two groups and these data points will be recorded in a password protected document for data analysis.

This study aims to identify if lengthy recommendations for convalescence after inguinal hernia surgery are necessary and determine the impact of allowing the individual patient to have some autonomy in a recommendation to return to physical activity based on their own comfort level. This study could provide the surgical community with a more structured response after this common surgical procedure, as well as potentially reduce convalescence times for individual patients, leading to less economic burden on the individual and the community with returning to work precautions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Clinical diagnosis of unilateral inguinal hernia
  • •Must be undergoing surgery
  • •Must be able to consent

排除标准

  • •Bilateral inguinal hernia
  • •Recurrent inguinal hernia
  • •Surgery scheduled with additional concomitant procedures

研究组 & 干预措施

Activity as tolerated

Experimental

Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".

干预措施: Removal of postoperative lifting restrictions (Behavioral)

Standard Lifting Restrictions

No Intervention

Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".

结局指标

主要结局

Physiological parameter- Hernia recurrence

时间窗: 2 years

Study participants will be followed for 2 years following hernia surgery to evaluate for hernia recurrence in both study arms. Hernia recurrence would be determined by documentation in medical record by surgical teams.

Physiological parameter- Postoperative Complications

时间窗: 2 months

Study participants will be evaluated after 2 months for incidence of postoperative complication due to hernia surgery. This includes seroma, hematoma, bleeding, surgical site infection, and wound dehiscence. This will be obtained from participant medical record as documented by clinical providers, primary care providers, surgery, and emergency medicine.

次要结局

  • Questionnaire- Postoperative Activity levels(6 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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