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Completed

NCT Number: NCT01870817

Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.

It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).

The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.

If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.

The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.

Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
  • suitable for home enteral nutrition

Exclusion criteria

  • inability to provide written informed consent

Treatment and study plan

Home jejunostomy feeding

Dietary Supplement

Primary outcomes

  1. Participant recruitment and retention rates

    Time frame: 7 months

    This pilot study will inform the design and planning of a larger multi-centre study

Secondary outcomes

  1. Quality of life

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Variability in disease specific and generic quality of life measures will be assessed

  2. Nutritional parameters

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Absolute body weight

  3. Health economics

    Time frame: 7 months

    Estimates of healthcare costs for the duration of the study will be calculated

  4. Readmission rates

    Time frame: 7 months

    Readmission rate to hospital during the study period

  5. Qualitative analysis

    Time frame: 8 weeks

    Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed

  6. Food intake

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Self-completed 3 day food diaries will be assessed

  7. Nutritional parameters

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Body mass index

  8. Nutritional parameters

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Mid arm circumference

  9. Nutritional parameters

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Triceps fold thickness

  10. Nutritional parameters

    Time frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

    Grip strength

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • University of Leicester
  • University of Sheffield
  • University of Warwick

Registry information

Official study title

A Pilot Study Investigating the Effect of Post-operative Home Jejunostomy Feeding on Quality of Life and Nutritional Parameters in Patients With Oesophago-gastric Cancer

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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