Physiotherapy
Other4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
NCT Number: NCT03808584
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
BundeswehrZentralkrankenhaus, Koblenz, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(in all four participating centres):
4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
Time frame: 24 months postsurgery
Incidence of incisional hernia diagnosed by ultrasound and clinical examination
Time frame: 2 months, 12 months, 24 months after surgery
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 days after surgery, at discharge, 2 months after surgery
Exercise type and number of repetitions
Time frame: End of hospital stay, expected to be up to 4 weeks
Length of hospital stay
Time frame: 2 months, 12 months, 24 months after surgery
Hospital readmission
Time frame: 2 months, 12 months, 24 months after surgery
Re-operation
Time frame: 2 months and 24 months after surgery
Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons
Contact information is provided by the study sponsor or research team.
Guido Beldi, MD
CONTACT
31 632 48 18 ext. 0041
Stéphanie Perrodin, MD
CONTACT
31 632 48 18 ext. 0041
Insel Gruppe AG, University Hospital Bern
Other
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