Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.

NCT03466593 | Completed

• 1 other identifier: FoU i VGR: 238701
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
2. 2.A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair \<6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.

Conditions

Pancreas Cancer

Keywords

Prehabilitation; Recovery; Complications

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• EORTC-module generic

  Whole study period from inclusion to one year after surgery

• EORTC-module specific for pancreas cancer

  Whole study period from inclusion to one year after surgery

• EORTC-module for fatigue

  Whole study period from inclusion to one year after surgery

• The Postoperative Recovery Profile

  Whole study period from inclusion to one year after surgery

• Pancreatic cancer disease impact (PACADI) score

  Whole study period from inclusion to one year after surgery

Study Arms (4)

Prospective cohort-prehabilitation

EXPERIMENTAL

A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.

Other: Prehabilitation

Retrospective cohort

ACTIVE COMPARATOR

Routine care before the prehabilitation program was introduced

Other: Routine care

Extra early mobilization

EXPERIMENTAL

Mobilization the day of surgery

Other: Extra early mobilization

Traditional mobilization

ACTIVE COMPARATOR

Routine care with mobilization the day after surgery

Other: Standard mobilization

Interventions

Prehabilitation OTHER

Prehabilitation concerning eating, smoking, drinking and physical activity

Prospective cohort-prehabilitation

Routine care OTHER

Preoperative information

Retrospective cohort

Extra early mobilization OTHER

Mobilization the day of surgery

Extra early mobilization

Standard mobilization OTHER

Mobilization the day after surgery

Traditional mobilization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo pancreatic surgery

You may not qualify if:

• Preoperative injury or disease making it impossible to perform the intervention

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Göteborg University

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33827537 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. A prospective cohort compared to historical controls 2. A randomized, controlled, intervention study.

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 15, 2018
• Study Start: December 18, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

SE (1)