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

Pancreas Cancer Clinical Trial

— PreMob  

Official title:

Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466593
• Other study ID #: FoU i VGR: 238701
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Prehabilitation
Prehabilitation concerning eating, smoking, drinking and physical activity
• Routine care
Preoperative information
• Extra early mobilization
Mobilization the day of surgery
• Standard mobilization
Mobilization the day after surgery

Locations

Country	Name	City	State
Sweden	Göteborg University	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Standardized complications according to register	Whole study period from inclusion to one year after surgery
Primary	PaO2	Arterial oxygen pressure	The day before surgery to the first day after surgery
Secondary	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
Secondary	EORTC-module specific for pancreas cancer	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Spirometry	Vital capacity	From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Secondary	Lenght of stay	Length of stay at the hospital	From the day before surgery to discharge from the hospital (app 7-14 days)