Enteral Feeding in Discharged Patients

NCT ID: NCT02155140

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-01-31

Brief Summary

Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Following discharge from hospital the mechanics of the surgery leads to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and gastro-oesophageal reflux which usually results in reduced dietary intake and further weight loss. In patients who have undergone upper gastrointestinal resections there are no studies examining the benefit of nutritional supplementation following hospital discharge, however, studies in other groups of surgical patients have failed to show benefit. Despite patients who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no evidence demonstrating the value or not of nutritional supplementation following hospital discharge.

Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will exacerbate the reduced quality of life and fatigue patients' already experience. The investigators hypothesise that improving patient's nutritional intake following hospital discharge will improve their quality of life and fatigue levels.

Detailed Description

For patients undergoing upper gastrointestinal (GI) surgery for cancer:

1. Because of the nature of upper gastrointestinal surgery these patients have been shown to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and to a greater extent than other groups of surgical patients. Quality of life and fatigue is a major issue after upper GI surgery.

2. Nutritional supplementation via a jejunostomy after hospital discharge is only done routinely for all patients in 10%, and for selected patients in 20% of United Kingdom (UK) hospitals.

3. Derriford hospital is very unusual in that 85% of patients are given home jejunal feeding.

4. In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius Kabil (a global health care company).

5. There are no studies of home nutritional supplementation in upper GI surgical patients.

6. Studies of home nutritional supplementation in surgical patients having undergone colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite weight gain.

7. The process of enteral nutrition may be associated with a reduction in quality of life.

8. There is a need for a clinical trial to establish the benefit of home enteral nutritional supplementation. The results of any such trial may influence the highly variable nutritional present practice and may influence the surgeons desire to place a feeding jejunostomy (or not) at surgery which is associated with clinical complications.

Conditions

Surgical Resection of an Upper Gastrointestinal Malignancy; Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Jejunal feeding

Nutritional supplementation via their jejunostomies for six weeks post hospital discharge, with continued assessment for a further 18 weeks.

Group Type: ACTIVE_COMPARATOR

Jejunal feeding

Intervention Type: DIETARY_SUPPLEMENT

A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.

No jejunal feeding

No jejunal feeding of patients for six weeks following hospital discharge, with continued assessment for a further 18 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Jejunal feeding

A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients able to give written informed consent,
• Have had a feeding jejunostomy placed at surgery,
• Competent (or their carer) to set up and use the jejunostomy feeding apparatus themselves.

Exclusion Criteria

• Participating in another interventional trial,
• Age <18,
• Pre-operative BMI > 35,
• Pre-operative BMI <18,
• Oral intake at hospital discharge of > 90% of requirements,
• It is felt that they or their carers would not to cope with home tube feeding Patients unable to give written informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Lewis, MBBS, MD

Role: STUDY_DIRECTOR

University Hospital Plymouth NHS Trust

Locations

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

10/H0106/80

Identifier Type: OTHER

Identifier Source: secondary_id

R&D 11/P/022

Identifier Type: -

Identifier Source: org_study_id