Quality of Life After Oesophageal or Gastric Cancer Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01657175
• Date of registration: 29/06/2012
• Prospective Registration: No
• Primary sponsor: Region Skane
• Public title: Quality of Life After Oesophageal or Gastric Cancer Surgery
• Scientific title: Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.
• Date of first enrolment: January 2009
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01657175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Care Provider).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Jan Johansson, MD PHD
• Affiliation: Department of surgery, Skåne university hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with any stage tumours in the distal third of the oesophagus including type
II tumours at the gastro-oesophageal junction

- Transthoracic oesophageal resection with gastric tube reconstructions and circular
stapled anastomoses in the upper right chest Postoperative clinical courses without
complications, and postoperative anastomotic radiograms without anastomotic leakage

- Macro and microscopically tumour free upper resection margins Willingness, physical
and mental capability to comply with the result of the randomization, and ability to
follow the study protocol

- Adult >18 years

- Living in the southern of Sweden (Skåne county)

Exclusion Criteria:

- Preoperative or planned postoperative chemotherapy or radiotherapy to the tumour area
known at the time of discharge from the hospital.

- Postoperative need for continuous treatment with proton pump inhibitors (PPIs) or
histamine-2 blockers. Treatment with steroidal or non steroidal anti inflammatory
drugs other than occasionally

- Known allergy or side effects to PPIs preventing continuous treatment for one year

- Present drug or alcohol abuse

- Failure to attend at least one postoperative visit



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Oesophageal Cancer

Gastric Cancer

Quality of Life

Intervention(s)

Other: Supportive care

Primary Outcome(s)

Quality of Life [Time Frame: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge]

Secondary Outcome(s)

Contacts with the health care system [Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.]

Satisfaction with care [Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.]

sense of coherence (KASAM) [Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.]

Informational need [Time Frame: At dischage, 2 weeks, 2, 4 and 6 months after discharge.]

Secondary ID(s)

2009 /117

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Skane University Hospital