Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease

NCT03770117 | Completed

• 1 other identifier: B00101
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether prehabilitation supervised by an appropriate multimodality team improves indices of sarcopenia in patients scheduled to undergo pancreatoduodenectomy.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreas; Cancer; Sarcopenia; Cachexia; Prehabilitation; Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• CT Scan Comparison

  CT Scans from patients which underwent the Prehabilitation \& standard care will be compared.

  Within last 5 years.

Study Arms (2)

Prehabilitation

In this arm of the study, participants will undergo prehabilitation prior to surgery. This is intended to increase the participants overall health prior to surgery to try and increase their general well-being during and after surgery. Prehabilitation is multimodal therapy comprising: 1. Assessment for malnutrition and nutritional support dependent on the outcome 2. Optimisation of management of pancreatic exocrine insufficiency 3. Assessment of muscle mass and strength 4. Individually tailored, goal directed exercise regimen under the care of physiotherapy

Procedure: Prehabilitation

Standard Procedure

In this arm, participants will not receive any Rehabilitation prior to the surgery. This is the current standard care and will act as the control data for this study.

Procedure: Standard Procedure

Interventions

Prehabilitation PROCEDURE

Participants who underwent Prehabilitation will have their CT scans analysed.

Prehabilitation

Standard Procedure PROCEDURE

Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.

Standard Procedure

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a pancreatoduodenectomy. Control group will have had standard care and these CT Scan results will be compared with those who have undergone prehabilitation.

You may qualify if:

• Patients treated by pancreatic resection
• Surgery for malignancy
• Patients aged over 16
• CT scans available for assessment

You may not qualify if:

• Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway
• Aged under 16
• Patients not undergoing pancreatic resection

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Gtr Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Sarcopenia; Cachexia

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

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 Officials

• Saurabh Jamdar

  Manchester University NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: October 4, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

GB (1)