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Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

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NHS Trust

Status

Completed

Conditions

Esophageal Neoplasms

Treatments

Dietary Supplement: Home jejunostomy feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT01870817
34769
12447 (Other Identifier)
PB-PG-0610-22480 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Home jejunostomy feeding
Active Comparator group
Description:
Six weeks of post hospital discharge home enteral feeding
Treatment:
Dietary Supplement: Home jejunostomy feeding
Control
No Intervention group
Description:
Standard care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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