跳至主要内容
临床试验/NCT03808584
NCT03808584招募中不适用

Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery

Insel Gruppe AG, University Hospital Bern10 个研究点 分布在 2 个国家目标入组 588 人开始时间: 2019年5月20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
588
试验地点
10
主要终点
Incidence of incisional hernia 24 months postsurgery

研究概览

简要总结

The current practice to avoid incisional hernia, one of the most frequent complications following abdominal surgery, is to minimize core muscle activity in the postoperative phase. However, there is no evidence to support the association of core muscle activity and increased incidence of incisional hernia. On the contrary, it is likely that reduced physical activity could lead to physical deconditioning, chronic postsurgical pain (CPSP), and sarcopenia. The investigators will conduct a prospective multicentric randomized clinical trial to compare standard of care to core muscle exercises targeting the abdominal muscles immediately postsurgery. The principle hypothesis is that neither specific exercises of core muscles before and after surgery nor physical restriction alter the incidence of incisional hernias. Secondly the impact of postoperative rehabilitation on CPSP and sarcopenia will be assessed.

详细描述

The current practice to avoid incisional hernia, one of the most frequent complications following abdominal surgery, is to minimize core muscle activity in the postoperative phase. Therefore the patients are instructed not to bear or lift weights and to limit physical activities in the first 8-12 weeks after surgery. However, there is no evidence to support the association of core muscle activity and increased incidence of incisional hernia. On the contrary, it is likely that reduced physical activity and deconditioning of the core muscles is associated with muscle catabolism, which may lead to physical deconditioning, chronic postsurgical pain (CPSP), and sarcopenia. CPSP is primarily a major burden in terms of reduced quality of life and resource utilization whereas sarcopenia in addition is increasingly recognized as an important independent risk factor for numerous adverse clinical outcomes and mortality.

The investigators will conduct a prospective multicentric randomized clinical trial to compare standard of care to core muscle exercises targeting the abdominal muscles immediately postsurgery. The principle hypothesis is that neither specific exercises of core muscles before and after surgery nor physical restriction alter the incidence of incisional hernias. Secondly the impact of postoperative rehabilitation on CPSP and sarcopenia will be assessed. The patients will be divided into two study arms, one receiving standard of care and the other receiving the intervention. The intervention consists of four specific core muscle exercises to perform daily during the first two months after surgery. Follow-up will be at two, twelve and twenty-four months with clinical examination and ultrasound to detect incisional hernias, assessment chronic postsurgical pain and its treatment and evaluation of muscle mass on CT scans.

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
Single (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

  • At the University Hospital of Bern, Kantonsspital Solothurn and Olten and BundeswehrZentralkrankenhaus Koblenz:
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Age > 18 years
  • Capable of judgment
  • Undergoing elective or emergency abdominal surgery
  • Laparoscopic or open surgery, midline or transverse incision
  • At the University Hospital of Lausanne:
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Age > 18 years
  • Capable of judgment
  • Undergoing elective open abdominal surgery
  • Midline or transverse incision
  • Exclusion criteria (in all four participating centres):
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders (chronic depression, under antidepressants or neuroleptics), dementia, etc. of the participant
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Neuromuscular diseases (such as myasthenia gravis or wheelchair-bound patient)
  • Preexisting chronic pain disorder, patients under chronic opioid therapy (WHO II and III) or pain modulating drugs (antidepressive medication or antiepileptic medication)
  • End-stage disease
  • Patients with preexisting abdominal wall mesh, with the exception of inguinal mesh (after inguinal hernia repair)

排除标准

  • 未提供

研究组 & 干预措施

Control group

No Intervention

The patients in the control group will receive standard physiotherapy and will be instructed to limit core muscle activity and weight bearing according to their pain symptomatology. Standard physiotherapy for all hospitalised patients includes early mobilization and exercises to prevent thrombosis and pulmonary complications (atelectasis, pneumonia, diaphragmatic deconditioning), balance training and endurance and exercise training

Intervention group

Experimental

The patients in the intervention group will be given exercises to perform postoperatively.They will be instructed by a physiotherapist in how to perform the four specific exercises targeting core muscles. The patient will perform these exercises daily during hospitalization under the supervision of the physiotherapist and then at home for two months after the operation. The intensity of the exercises will be adjusted daily to the physical capabilities of the patient. They will also benefit from standard physiotherapy as described above.

干预措施: Physiotherapy (Other)

结局指标

主要结局

Incidence of incisional hernia 24 months postsurgery

时间窗: 24 months postsurgery

Incidence of incisional hernia diagnosed by ultrasound and clinical examination

次要结局

  • Exercise(2 days after surgery, at discharge, 2 months after surgery)
  • Length of hospital stay(End of hospital stay, expected to be up to 4 weeks)
  • Incidence of Chronic postsurgical pain(2 months, 12 months, 24 months after surgery)
  • Readmission rate(2 months, 12 months, 24 months after surgery)
  • Re-operation rate(2 months, 12 months, 24 months after surgery)
  • Incidence of Sarcopenia(2 months and 24 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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