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Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.
This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.
The study includes two substudies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort-prehabilitation | Experimental | A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol. |
|
| Retrospective cohort | Active Comparator | Routine care before the prehabilitation program was introduced |
|
| Extra early mobilization | Experimental | Mobilization the day of surgery |
|
| Traditional mobilization | Active Comparator | Routine care with mobilization the day after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | Prehabilitation concerning eating, smoking, drinking and physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Standardized complications according to register | Whole study period from inclusion to one year after surgery |
| PaO2 | Arterial oxygen pressure | The day before surgery to the first day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC-module generic | Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life | Whole study period from inclusion to one year after surgery |
| EORTC-module specific for pancreas cancer |
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Inclusion Criteria:
Exclusion Criteria in substudy b:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Göteborg University | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33827537 | Derived | Fagevik Olsen M, Becovic S, Dean E. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial. BMC Surg. 2021 Apr 7;21(1):185. doi: 10.1186/s12893-021-01187-2. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Routine care | Other | Preoperative information |
|
| Extra early mobilization | Other | Mobilization the day of surgery |
|
| Standard mobilization | Other | Mobilization the day after surgery |
|
Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life
| Whole study period from inclusion to one year after surgery |
| EORTC-module for fatigue | Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life | Whole study period from inclusion to one year after surgery |
| The Postoperative Recovery Profile | Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem | Whole study period from inclusion to one year after surgery |
| Pancreatic cancer disease impact (PACADI) score | Disease specific questionnaire, 8 statements rated on a visual analogue scale from 0 (no problem) to 10 (worst imaginable problem). Sum score are used for analysis (Range 0-80) | Whole study period from inclusion to one year after surgery |
| Spirometry | Vital capacity | From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation |
| Lenght of stay | Length of stay at the hospital | From the day before surgery to discharge from the hospital (app 7-14 days) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |