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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
BundeswehrZentralkrankenhaus
RECRUITING
Koblenz
Switzerland
University Hospital of Bern, Inselspital
RECRUITING
Bern
CHUV, University Hospital of Lausanne
RECRUITING
Lausanne
Kantonsspital Olten
TERMINATED
Olten
Bürgerspital Solothurn
WITHDRAWN
Solothurn
Contact Information
Primary
Guido Beldi, MD
guido.beldi@insel.ch
31 632 48 18
Backup
Stéphanie Perrodin, MD
stephanie.perrodin@insel.ch
31 632 48 18
Time Frame
Start Date: 2019-05-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 588
Treatments
No_intervention: Control group
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
Experimental: Intervention group
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.
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov