Psychological Preparation for Colorectal Surgery: Impact of Video Education. A Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- The primary end-point ( main aim ) will be length of hospital stay.
Study Overview
Brief Summary
Since the introduction and favourable early results of enhanced recovery programmes more than a decade ago, such programmes have become increasingly popular following major surgery. Many elements of these programmes are based on solid evidence and derived from published trials. These programmes optimize different factors to reduce the stress of surgery with the aim of improving patient outcome and speed up recovery after surgery. Key factors prior to surgery are conditioning of expectations and optimizing associated disease. Strategies during the operation include use of short-acting anaesthetic (sleeping) agents, maintenance of normal temperatures and minimal access surgery (keyhole surgery).
Care after surgery is optimized with appropriate analgesia (pain killers), early mobilisation (walking) and early feeding. This combined approach reduces hospital stay to 2-4 days. There is also evidence that the improvements resulting from the implementation of an enhanced recovery programme do not cause significant deterioration in quality of life or transfer costs to another component of health care.
The relative contribution of each of the single elements in the enhanced recovery programme remains uncertain. Good patient information gives confidence and improves overall outcome. No studies have examined the impact of video education on recovery.
The aim of this study is to explore the use of video information provision for patients participating in an enhanced recovery programme.
Detailed Description
TRIAL DESIGN:
A randomised controlled trial of the impact of video education in preparing patients for surgery within an enhanced recovery programme. Patients will be recruited from Leicester General Hospital and will include everyone undergoing colorectal(bowel) surgery. A standard protocol (treatment regime) is in place for all such patients. The primary end-point (main aim) will be length of hospital stay. Secondary end-points (other factors to be considered) will be patient satisfaction scores (using SF-36 outcomes in patients) and will allow the investigation of the potential implications of incorporating video education of enhanced recovery programmes into routine clinical practice.
METHODS:
All surgeons treating the patients in this trial will have a specialist interest in colorectal (bowel) surgery. All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible. Patients who cannot speak or understand english will have interpreters. Ethics approval will be sought and informed (signed) consent both for the surgery and the trial will be obtained. The study group will get a video and leaflet and the control group will receive a leaflet only. Randomisation (Division into groups) will be done using a table of random numbers to assign each study participant to a group. The consultants and registrars in charge of taking care of patients after their surgery will not be aware of which group patients belong to and a standard discharge criteria will be used (Patients for discharge should have normal observations and normal bloods results, free from lines in the hands and tubes in the waterworks, be fully mobile (walking), able to get in and out of bed unaided and dress independently. Hospital stay will be recorded in days from the time the patient is admitted to hospital. Social reasons for non-discharge such as delay in setting up home help etc will be recorded for both groups of patients.
The time to passage of flatus (wind from the back passage) and bowel motion (stool) will be recorded for each patient. Episodes of nausea and vomiting (sickness) will also be recorded as will any complication up to 30 days after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible
Exclusion Criteria
- •Patients who are unfit for surgery or undergoing emergency surgery will be excluded.
Outcomes
Primary Outcomes
The primary end-point ( main aim ) will be length of hospital stay.
Time Frame: Participants will be assessed for the duration of their hospital stay which is an average of 7 days.
Hospital stay will be recorded in days from the time the patient is admitted to hospital.
Secondary Outcomes
- Secondary end-points will be patient satisfaction scores(Measured 3 months after discharge)