EsophagectomyNCT00585624
Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy
A study testing Impact Advanced Recovery and No supplement in people with Esophagectomy and Pancreaticoduodenectomy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Pancreaticoduodenectomy
- What is being tested?
- Impact Advanced Recovery and No supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
- Surgery will be scheduled 5-7 days after consent date -
Who cannot join
- Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
- Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
- Patients with known pre-existing renal failure requiring a low protein diet
- Patient is unable to drink 3 servings/day of a liquid supplement -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
Official title: Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy
We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.
- Conditions
- Esophagectomy, Pancreaticoduodenectomy
- Being tested
- Impact Advanced Recovery, No supplement
- Keywords
- Esophagectomy, Pancreaticoduodenectomy, Whipple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact Advanced RecoveryDietary supplement
Nutritional supplement
No supplementDietary supplement
No supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supplement: 3 servings/day of Impact Advanced Recovery in addition to regular food or any other supplements recommended or desired by patient or primary care/surgical team. Receives: Dietary Supplement: Impact Advanced Recovery |
| 2 | Placebo comparator | Standard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team. Receives: Dietary Supplement: No supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative stay in days
Measured: Postoperative stay in hospital & 30 days
Secondary outcomes (1)
Incidence of major complications
Measured: Postoperative stay in hospital & 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startApr 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth A Kudsk, MD, Principal investigator, University of Wisconsin School of Medicine & Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585624
- Sponsor's protocol ID
- 06206
- Other IDs
- #H-2006-0401
- Status last verified
- Oct 2015
- First submitted
- 26 Dec 2007
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT00585624
- Acronym / sponsor ID
- 06206
- Conditions
- Esophagectomy, Pancreaticoduodenectomy
- Keywords
- Esophagectomy, Pancreaticoduodenectomy, Whipple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Jan 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.
We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Impact Advanced RecoverySupplement: 3 servings/day of Impact Advanced Recovery in addition to regular food or any other supplements recommended or desired by patient or primary care/surgical team. |
| 2 | Placebo comparator | Dietary Supplement: No supplementStandard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
- Surgery will be scheduled 5-7 days after consent date -
Key exclusion criteria (4 listed)
- Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
- Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
- Patients with known pre-existing renal failure requiring a low protein diet
- Patient is unable to drink 3 servings/day of a liquid supplement -
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 |
|---|---|---|
| Impact Advanced RecoveryNutritional supplement | Dietary supplement | 1 |
| No supplementNo supplement | Dietary supplement | 2 |
Primary outcome
Postoperative stay in days
Time frame: Postoperative stay in hospital & 30 days
1 secondary outcome
Incidence of major complications
Time frame: Postoperative stay in hospital & 30 days
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 Oct 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.
Kenneth A Kudsk, MD principal investigator
University of Wisconsin School of Medicine & Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact Advanced Recovery and No supplement in people with Esophagectomy and Pancreaticoduodenectomy, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 4 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 Oct 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 United States. 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 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?
Postoperative stay in days (time frame: Postoperative stay in hospital & 30 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 Oct 2015.