Rectal CancerNCT00687570
Bowel Preparation Before Rectal Cancer Surgery
A study testing Fresubin Energy Drink and Laxabon® in people with Rectal Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem. Cleaning the bowel without complications for the patient is one of the aims for this study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Fresubin Energy Drink and Laxabon®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2008to Jul 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rectal cancer
- men
- women
- age 18-90 years
Who cannot join
- acute ileus
- seriously dementia
- metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery
Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem.
Cleaning the bowel without complications for the patient is one of the aims for this study.
The other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.
Read the detailed description
In our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment.
The actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. Nutritional drinks are to be used instead of traditional bowel preparation. Patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, Laxabon® (A) or nutritional drinks, Fresubin Energy drink (B) before surgery. Patients in subgroup B take nutritional drinks seven days before surgery instead of ordinary food. Bowel purity degree is measured peroperatively.
The secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. For four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup B (Fresubin Energy drink 15-30 kcal/kg*day). Subgroup A only eats ordinary food throughout the same period, before surgery.
Bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. All patients in the study keep records of physical activity daily, and food diary twice a week. Complications are registered.
Blood samples for hormones and electrolytes are taken before and after surgery.
- Conditions
- Rectal Cancer
- Being tested
- Fresubin Energy Drink, Laxabon®
- Keywords
- patients with rectal cancer undergoing surgery, Bowel purity degree, Bowel preparation, Rectal cancer, Nutritional status, complications with traditional bowel preparation, Complications, Physiological status
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin Energy DrinkDietary supplement
Fresubin energy drink 30 kcal/kg*dag-1, seven days before surgery
Laxabon®Drug
Laxabon® 4 litres starting the day before surgery
| Study group | Role | What they receive |
|---|---|---|
| B | Other | Nutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon® Receives: Dietary Supplement: Fresubin Energy Drink |
| A | Other | Traditional bowel preparation with Laxabon® Receives: Drug: Laxabon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel purity degree
Measured: day of surgery
Secondary outcomes (3)
Nutritional status
Measured: before and after operation
Complications
Measured: day of surgery and days after surgery
physiological function
Measured: before and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Gustafsson, Karolinska Institutet
- Investigators
- Ulf Gustafsson, MD, PhD, Principal investigator, Karolinska Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687570
- Sponsor's protocol ID
- 2008/332-31
- Status last verified
- Feb 2015
- First submitted
- 28 May 2008
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Preparation With Nutritional Drinks Instead of Traditional Bowel Preparation Before Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT00687570
- Acronym / sponsor ID
- 2008/332-31
- Conditions
- Rectal Cancer
- Keywords
- patients with rectal cancer undergoing surgery, Bowel purity degree, Bowel preparation, Rectal cancer, Nutritional status, complications with traditional bowel preparation, Complications, Physiological status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Jun 2008 (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.
Traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem.
Cleaning the bowel without complications for the patient is one of the aims for this study.
The other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.
Detailed description
In our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. As a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. We think that this treatment has worked well on the patients but no scientific studies have been done on these patients. As a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment.
The actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. Nutritional drinks are to be used instead of traditional bowel preparation. Patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, Laxabon® (A) or nutritional drinks, Fresubin Energy drink (B) before surgery. Patients in subgroup B take nutritional drinks seven days before surgery instead of ordinary food. Bowel purity degree is measured peroperatively.
The secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. For four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup B (Fresubin Energy drink 15-30 kcal/kg*day). Subgroup A only eats ordinary food throughout the same period, before surgery.
Bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. All patients in the study keep records of physical activity daily, and food diary twice a week. Complications are registered.
Blood samples for hormones and electrolytes are taken before and after surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Other | Dietary Supplement: Fresubin Energy DrinkNutritional drinks 7 days before surgery instead of traditional Bowel preparation with Laxabon® |
| A | Other | Drug: Laxabon®Traditional bowel preparation with Laxabon® |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- rectal cancer
- men
- women
- age 18-90 years
Key exclusion criteria (3 listed)
- acute ileus
- seriously dementia
- metastatic disease
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 |
|---|---|---|
| Fresubin Energy DrinkFresubin energy drink 30 kcal/kg*dag-1, seven days before surgery | Dietary supplement | B |
| Laxabon®Laxabon® 4 litres starting the day before surgery | Drug | A |
Primary outcome
Bowel purity degree
Time frame: day of surgery
3 secondary outcomes
Nutritional status
Time frame: before and after operation
Complications
Time frame: day of surgery and days after surgery
physiological function
Time frame: before and after surgery
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 20 Feb 2015.
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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.
Ulf Gustafsson, MD, PhD principal investigator
Karolinska Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin Energy Drink and Laxabon® in people with Rectal Cancer, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 3 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 20 Feb 2015. 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 Sweden. 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?
Bowel purity degree (time frame: day of surgery). 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 20 Feb 2015.