Patients Following Gastrointestinal SurgeryNCT00546975
Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
A study testing Resource Support® and Resource Protein® in people with Patients Following Gastrointestinal Surgery, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Nutritional supplementation in postoperative recovery is still debated. Functional impairment is known to develop both secondary to inflammatory processes or secondary to reduced nutritional intake (e.g. disease induced anorexia). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Patients Following Gastrointestinal Surgery
- What is being tested?
- Resource Support® and Resource Protein®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Sep 2009
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are > 50 years of age and < 80 years
- Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study.
- Patients who have an ECOG performance status (presurgery) of 0, 1 or 2 (Appendix II).
- Patients able to orally consume 500 mL or more of liquid a day after adaption
- Patients undergoing elective gastrointestinal surgery [e.g. Colorectal surgery: colectomy, hemicolectomy, proctectomy; Small bowel resection/surgery; liver resection, splenectomy, non-whipple pancreatic surgery]
Who cannot join
- Patients who are > 80 years of age and < 50 years
- Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
- Patients undergoing Whipple´s procedure, gastrectomy, oesophageal resection
- Patients who get preoperative nutritional support
- Patients taking supplements (EPA, DHA)
- Any concomitant severe disease e.g.
Show all 17Show fewer
- Patients with respiratory failure (FEV<0.8l/sec)
- Patients with renal failure (Cr > 3mg/dl or dialysis patients)
- Patients with hepatic dysfunction (Child >A)
- Patients with cardiac failure (NYHA > III)
- Patients suffering from an intestinal obstruction or ileus
- Patients with an Hb level of >8 g/dL experiencing gastrointestinal haemorrhaging
- Patients with HIV
- Patients requiring immunosuppression treatments
- Pregnancy
- Patients undergoing emergency surgery
- Other patients determined by a study investigator to be inappropriate for enrolment in this study
Trial locations and contacts
1 site in 1 country.
About this study
Nutritional supplementation in postoperative recovery is still debated. Functional impairment is known to develop both secondary to inflammatory processes or secondary to reduced nutritional intake (e.g. disease induced anorexia). Since major surgery represents a traumatic event, surgical patients are at increased risk of malnutrition due to starvation, activation of neuroendocrine stress axis, inflammation and the subsequent increase in metabolic rate. Gastrointestinal surgery in particular can create additional problems as it often directly affects and limits dietary intake postoperatively and these effects frequently continue after discharge. Whereas manifest malnutrition occurs in about 15% of general surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9% occur in all surgical patients during the first two months. Moreover studies have shown that the nutritional status generally declines in hospital and both functional and nutritional status deteriorate for two months after discharge in malnourished surgical patients.
Most studies that have investigated nutritional support in the surgical setting have concentrated on perioperative or short term postoperative supplementation and focussed on in-hospital infection and complication rate.
Read more
Hypothesis I:
Nutritional intake is decreased after surgery which results in an impaired nutritional status which in turn is associated with a decreased functional status. Protein rich nutritional supplementation is able to reverse nutritional depletion and restore functionality.
Hypothesis II:
Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich nutritional supplementation aims to prevent inflammatory complications and therefore improves functional status and reduces morbidity. In patients with high risk for inflammation, a higher effect of anti-inflammatory oral nutrition on recovery of functional status is expected.
This study aims to determine whether 4 week oral nutritional supplementation and/ or specialized nutrients is effective in restoring functional status and reducing morbidity in surgical patients.
- Being tested
- Resource Support®, Resource Protein®, Placebo
- Keywords
- gastrointestinal surgery, nutritional intervention, functional status, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource Support®Dietary supplement
Resource Protein®Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Resource Support® Novartis Receives: Dietary Supplement: Resource Support® |
| 2 | Active comparator | Resource Protein®, Novartis Receives: Dietary Supplement: Resource Protein® |
| 3 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Component Summary (from SF 36 Quality of life questionnaire)
Measured: 4 weeks
Secondary outcomes (1)
hand grip strength
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Compliance unacceptably low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Following Gastrointestinal SurgeryStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Herbert Lochs, MD, Principal investigator, Charite Universitätsmedizin Berlin Dept. of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546975
- Sponsor's protocol ID
- 07.33.CLI
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT00546975
- Acronym / sponsor ID
- 07.33.CLI
- Keywords
- gastrointestinal surgery, nutritional intervention, functional status, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Compliance unacceptably low.
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Oct 2007 (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.
Nutritional supplementation in postoperative recovery is still debated. Functional impairment is known to develop both secondary to inflammatory processes or secondary to reduced nutritional intake (e.g. disease induced anorexia). Since major surgery represents a traumatic event, surgical patients are at increased risk of malnutrition due to starvation, activation of neuroendocrine stress axis, inflammation and the subsequent increase in metabolic rate. Gastrointestinal surgery in particular can create additional problems as it often directly affects and limits dietary intake postoperatively and these effects frequently continue after discharge. Whereas manifest malnutrition occurs in about 15% of general surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9% occur in all surgical patients during the first two months. Moreover studies have shown that the nutritional status generally declines in hospital and both functional and nutritional status deteriorate for two months after discharge in malnourished surgical patients.
Most studies that have investigated nutritional support in the surgical setting have concentrated on perioperative or short term postoperative supplementation and focussed on in-hospital infection and complication rate.
Hypothesis I:
Nutritional intake is decreased after surgery which results in an impaired nutritional status which in turn is associated with a decreased functional status. Protein rich nutritional supplementation is able to reverse nutritional depletion and restore functionality.
Hypothesis II:
Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich nutritional supplementation aims to prevent inflammatory complications and therefore improves functional status and reduces morbidity. In patients with high risk for inflammation, a higher effect of anti-inflammatory oral nutrition on recovery of functional status is expected.
This study aims to determine whether 4 week oral nutritional supplementation and/ or specialized nutrients is effective in restoring functional status and reducing morbidity in surgical patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Resource Support®Resource Support® Novartis |
| 2 | Active comparator | Dietary Supplement: Resource Protein®Resource Protein®, Novartis |
| 3 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are > 50 years of age and < 80 years
- Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study.
- Patients who have an ECOG performance status (presurgery) of 0, 1 or 2 (Appendix II).
- Patients able to orally consume 500 mL or more of liquid a day after adaption
- Patients undergoing elective gastrointestinal surgery [e.g. Colorectal surgery: colectomy, hemicolectomy, proctectomy; Small bowel resection/surgery; liver resection, splenectomy, non-whipple pancreatic surgery]
Key exclusion criteria (17 listed)
- Patients who are > 80 years of age and < 50 years
- Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
- Patients undergoing Whipple´s procedure, gastrectomy, oesophageal resection
- Patients who get preoperative nutritional support
- Patients taking supplements (EPA, DHA)
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 |
|---|---|---|
| Resource Support® | Dietary supplement | 1 |
| Resource Protein® | Dietary supplement | 2 |
| Placebo | Dietary supplement | 3 |
Primary outcome
Physical Component Summary (from SF 36 Quality of life questionnaire)
Time frame: 4 weeks
1 secondary outcome
hand grip strength
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Compliance unacceptably low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Herbert Lochs, MD principal investigator
Charite Universitätsmedizin Berlin Dept. of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource Support® and Resource Protein® in people with Patients Following Gastrointestinal Surgery, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Jun 2011. 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 Germany. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Compliance unacceptably low.). Results are not available in the source record.
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?
Physical Component Summary (from SF 36 Quality of life questionnaire) (time frame: 4 weeks). 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 27 Jun 2011.