search
Back to results

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

Primary Purpose

Hernia Incisional, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hernia Incisional focused on measuring Core muscle exercise, rehabilitation, Incisional hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. 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)

Sites / Locations

  • BundeswehrZentralkrankenhaus
  • Kantonsspital OltenRecruiting
  • University Hospital of Bern, InselspitalRecruiting
  • CHUV, University Hospital of LausanneRecruiting
  • Bürgerspital Solothurn

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of incisional hernia 24 months postsurgery
Incidence of incisional hernia diagnosed by ultrasound and clinical examination

Secondary Outcome Measures

Incidence of Chronic postsurgical pain
Abdominal pain assessment by Visual Analog Scale (VAS). VAS score ranges from 0 (no pain) to 10 (worst possible pain). The mean VAS in the last 24 hours will be documented.
Exercise
Exercise type and number of repetitions
Length of hospital stay
Length of hospital stay
Readmission rate
Hospital readmission
Re-operation rate
Re-operation
Incidence of Sarcopenia
Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons

Full Information

First Posted
January 15, 2019
Last Updated
November 7, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
search

1. Study Identification

Unique Protocol Identification Number
NCT03808584
Brief Title
Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Official Title
Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia Incisional, Exercise
Keywords
Core muscle exercise, rehabilitation, Incisional hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
588 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
Primary Outcome Measure Information:
Title
Incidence of incisional hernia 24 months postsurgery
Description
Incidence of incisional hernia diagnosed by ultrasound and clinical examination
Time Frame
24 months postsurgery
Secondary Outcome Measure Information:
Title
Incidence of Chronic postsurgical pain
Description
Abdominal pain assessment by Visual Analog Scale (VAS). VAS score ranges from 0 (no pain) to 10 (worst possible pain). The mean VAS in the last 24 hours will be documented.
Time Frame
2 months, 12 months, 24 months after surgery
Title
Exercise
Description
Exercise type and number of repetitions
Time Frame
2 days after surgery, at discharge, 2 months after surgery
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
End of hospital stay, expected to be up to 4 weeks
Title
Readmission rate
Description
Hospital readmission
Time Frame
2 months, 12 months, 24 months after surgery
Title
Re-operation rate
Description
Re-operation
Time Frame
2 months, 12 months, 24 months after surgery
Title
Incidence of Sarcopenia
Description
Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons
Time Frame
2 months and 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guido Beldi, MD
Phone
31 632 48 18
Ext
0041
Email
guido.beldi@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Perrodin, MD
Phone
31 632 48 18
Ext
0041
Email
stephanie.perrodin@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Beldi, MD
Organizational Affiliation
Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
BundeswehrZentralkrankenhaus
City
Koblenz
ZIP/Postal Code
56070
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnulf Willms, PD
Phone
26128122801
Ext
0049
Email
ArnulfWillms@bundeswehr.org
Facility Name
Kantonsspital Olten
City
Olten
State/Province
Solothurn
ZIP/Postal Code
4600
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Dietz, Prof.
Phone
32 627 35 49
Ext
0041
Email
ulrich.dietz@spital.so.ch
Facility Name
University Hospital of Bern, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Beldi, Prof
Phone
+41316324818
Email
guido.beldi@insel.ch
First Name & Middle Initial & Last Name & Degree
Stéphanie Perrodin, MD
Phone
+41316324818
Email
stephanie.perrodin@insel.ch
Facility Name
CHUV, University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hubner, Prof
Phone
79 556 88 38
Ext
0041
Email
martin.hubner@chuv.ch
Facility Name
Bürgerspital Solothurn
City
Solothurn
ZIP/Postal Code
4500
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Dietz, Prof
Phone
+41623114343
Email
ulrich.dietz@spital.so.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23712287
Citation
Pommergaard HC, Burcharth J, Danielsen A, Angenete E, Haglind E, Rosenberg J. No consensus on restrictions on physical activity to prevent incisional hernias after surgery. Hernia. 2014 Aug;18(4):495-500. doi: 10.1007/s10029-013-1113-8. Epub 2013 May 28.
Results Reference
background
PubMed Identifier
26436600
Citation
Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
Results Reference
background
PubMed Identifier
16741597
Citation
Bruce J, Krukowski ZH. Quality of life and chronic pain four years after gastrointestinal surgery. Dis Colon Rectum. 2006 Sep;49(9):1362-70. doi: 10.1007/s10350-006-0575-5.
Results Reference
background
PubMed Identifier
27718001
Citation
Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Yamaguchi J, Nagino M. Surgery-Related Muscle Loss and Its Association with Postoperative Complications After Major Hepatectomy with Extrahepatic Bile Duct Resection. World J Surg. 2017 Feb;41(2):498-507. doi: 10.1007/s00268-016-3732-6.
Results Reference
background
PubMed Identifier
25123379
Citation
Itatsu K, Yokoyama Y, Sugawara G, Kubota H, Tojima Y, Kurumiya Y, Kono H, Yamamoto H, Ando M, Nagino M. Incidence of and risk factors for incisional hernia after abdominal surgery. Br J Surg. 2014 Oct;101(11):1439-47. doi: 10.1002/bjs.9600. Epub 2014 Aug 14.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs