Use of Video EducationNCT01547572
Psychological Preparation for Colorectal Surgery: Impact of Video Education
A study testing The study group will get a video and leaflet on enhanced recovery in people with Use of Video Education and Colorectal Surgery, run by Ihedioha, Ugo, M.D. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Use of Video Education, Colorectal Surgery
- What is being tested?
- The study group will get a video and leaflet on enhanced recovery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible
Who cannot join
- Patients who are unfit for surgery or undergoing emergency surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW
About this study
Official title: Psychological Preparation for Colorectal Surgery: Impact of Video Education. A Randomised Trial
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.
Read more
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.
Read the 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.
All patients will complete a questionnaire (SF-36) prior to surgery and at 3 months after surgery to assess satisfaction and return to normal activities such as leisure activities and work in the home etc.
DETAILS OF THE ENHANCED RECOVERY PROGRAMME:
Preoperative preparation (Prior to surgery) All patients will be allowed free fluids (liquids) and high calorie (energy) drinks for up to 2 hours before operation. Patients undergoing right hemicolectomy (right sided bowel surgery) will not receive bowel preparation (bowel cleansing) while those having left sided surgery will receive phosphate enema on the morning of surgery. All patients will receive antibiotic and DVT (blood clot) prophylaxis.
All patients will have baseline blood tests.
Anaesthesia (During surgery)
A standardised anaesthetic (sleeping) protocol (treatment regime) will be used for all patients. Normal temperature will be maintained throughout surgery and all operations will be carried out through the smallest incision (cut) necessary to complete the procedure. No nasogastric tubes (stomach tubes) will be used.
Postoperative pain and analgesia (Pain relief after surgery) Analgesia(Pain relief) will be provided in both groups for 48 hours via PCA (patient controlled pain relief), epidural (pain relief via injection at the back) or TAPP block (pain relief via injection on the belly).
Paracetamol will be administered concurrently with NSAIDS (non steroidal drugs) and tramadol for breakthrough pain once morphine is discontinued. Visual analogue (facial expression) pain scores at rest and movement will be measured daily until discharge. All analgesia (pain relieving drugs) used after surgery will be recorded including any discharge medication.
Diet and Fluids:
Oral fluids will be pushed immediately postoperatively (after surgery) in both groups. In addition, protein drinks and normal food will be encouraged in both groups from day 1. All lines in the arm will be removed by day 2 unless there is a clinical reason to maintain them. Both groups will have daily blood tests.
All patients will have chest physiotherapy (exercises) and will be encouraged to mobilise (walk) on day one with the help of a nurse or physiotherapist.
- Conditions
- Use of Video Education, Colorectal Surgery
- Being tested
- The study group will get a video and leaflet on enhanced recovery, The control group will receive a leaflet only
- Keywords
- Video education, Enhanced recovery, Reducing hospital stay, Improving patient satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study group will get a video and leaflet on enhanced recoveryProcedure or surgery
The study group will get a video and leaflet
The control group will receive a leaflet onlyProcedure or surgery
The control group will receive a leaflet only
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group will get a video and leaflet on enhanced recovery. Receives: Procedure: The study group will get a video and leaflet on enhanced recovery |
| Control group | No intervention | The control group will receive a leaflet only. Receives: Procedure: The control group will receive a leaflet only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point ( main aim ) will be length of hospital stay.
Hospital stay will be recorded in days from the time the patient is admitted to
hospital.
Measured: Participants will be assessed for the duration of their hospital stay which is an average of 7 days.
Secondary outcomes (1)
Secondary end-points will be patient satisfaction scores
Secondary end-points ( other factors to be considered ) will
be patient satisfaction scores ( using SF-36 outcomes in patients )
Measured: Measured 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Video EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ihedioha, Ugo, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547572
- Sponsor's protocol ID
- IhediohaU
- Status last verified
- Mar 2012
- First submitted
- 27 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Preparation for Colorectal Surgery: Impact of Video Education. A Randomised Trial
- ClinicalTrials.gov ID
- NCT01547572
- Acronym / sponsor ID
- IhediohaU
- Conditions
- Use of Video Education, Colorectal Surgery
- Keywords
- Video education, Enhanced recovery, Reducing hospital stay, Improving patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ihedioha, Ugo, M.D.
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
All patients will complete a questionnaire (SF-36) prior to surgery and at 3 months after surgery to assess satisfaction and return to normal activities such as leisure activities and work in the home etc.
DETAILS OF THE ENHANCED RECOVERY PROGRAMME:
Preoperative preparation (Prior to surgery) All patients will be allowed free fluids (liquids) and high calorie (energy) drinks for up to 2 hours before operation. Patients undergoing right hemicolectomy (right sided bowel surgery) will not receive bowel preparation (bowel cleansing) while those having left sided surgery will receive phosphate enema on the morning of surgery. All patients will receive antibiotic and DVT (blood clot) prophylaxis.
All patients will have baseline blood tests.
Anaesthesia (During surgery)
A standardised anaesthetic (sleeping) protocol (treatment regime) will be used for all patients. Normal temperature will be maintained throughout surgery and all operations will be carried out through the smallest incision (cut) necessary to complete the procedure. No nasogastric tubes (stomach tubes) will be used.
Postoperative pain and analgesia (Pain relief after surgery) Analgesia(Pain relief) will be provided in both groups for 48 hours via PCA (patient controlled pain relief), epidural (pain relief via injection at the back) or TAPP block (pain relief via injection on the belly).
Paracetamol will be administered concurrently with NSAIDS (non steroidal drugs) and tramadol for breakthrough pain once morphine is discontinued. Visual analogue (facial expression) pain scores at rest and movement will be measured daily until discharge. All analgesia (pain relieving drugs) used after surgery will be recorded including any discharge medication.
Diet and Fluids:
Oral fluids will be pushed immediately postoperatively (after surgery) in both groups. In addition, protein drinks and normal food will be encouraged in both groups from day 1. All lines in the arm will be removed by day 2 unless there is a clinical reason to maintain them. Both groups will have daily blood tests.
All patients will have chest physiotherapy (exercises) and will be encouraged to mobilise (walk) on day one with the help of a nurse or physiotherapist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: The study group will get a video and leaflet on enhanced recoveryThe study group will get a video and leaflet on enhanced recovery. |
| Control group | No intervention | Procedure: The control group will receive a leaflet onlyThe control group will receive a leaflet only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing planned bowel surgery for benign (non-cancerous) and malignant (cancerous) disease will be eligible
Key exclusion criteria (1 listed)
- Patients who are unfit for surgery or undergoing emergency surgery will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The study group will get a video and leaflet on enhanced recoveryThe study group will get a video and leaflet | Procedure or surgery | Study group |
| The control group will receive a leaflet onlyThe control group will receive a leaflet only | Procedure or surgery | Control group |
Primary outcome
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.
1 secondary outcome
Secondary end-points will be patient satisfaction scores
Time frame: Measured 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The study group will get a video and leaflet on enhanced recovery in people with Use of Video Education and Colorectal Surgery, run by Ihedioha, Ugo, M.D. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.