Pseudomyxoma PeritoneiNCT02374411
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
An observational study of Pseudomyxoma Peritonei and Appendiceal Neoplasms, run by Edward Hospital at 1 site in United States.
Trial summary
The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudomyxoma Peritonei, Appendiceal Neoplasms, Pancreatic Neoplasms
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIPEC surgeons based internationally
Who may be able to join
- Surgeon trained in and performing the HIPEC procedure
Who cannot join
- Not performing the HIPEC procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Survey of the Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.
- Conditions
- Pseudomyxoma Peritonei, Appendiceal Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Sarcoma
- Medical subject headings
- Pseudomyxoma Peritonei, Appendiceal Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Sarcoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC surgeons | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect questionnaire data from 150 HIPEC surgeons
Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197.
Measured: Three months
Secondary outcomes (2)
HIPEC surgeon practices of patient nutritional support assessed by questionnaire
Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197.
Measured: Three months
HIPEC surgeon attitudes toward patient nutritional support self-assessed by questionnaire
Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George I Salti, MD, Principal investigator, Edward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374411
- Sponsor's protocol ID
- EDW091114A
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of the Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
- ClinicalTrials.gov ID
- NCT02374411
- Acronym / sponsor ID
- EDW091114A
- Conditions
- Pseudomyxoma Peritonei, Appendiceal Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Edward HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Feb 2015 (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.
The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC surgeons | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIPEC surgeons based internationally
Key inclusion criteria (1 listed)
- Surgeon trained in and performing the HIPEC procedure
Key exclusion criteria (1 listed)
- Not performing the HIPEC procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect questionnaire data from 150 HIPEC surgeons
Time frame: Three months
Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197.
2 secondary outcomes
HIPEC surgeon practices of patient nutritional support assessed by questionnaire
Time frame: Three months
HIPEC surgeon attitudes toward patient nutritional support self-assessed by questionnaire
Time frame: Three months
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 Feb 2017.
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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.
George I Salti, MD principal investigator
Edward Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomyxoma Peritonei and Appendiceal Neoplasms, run by Edward Hospital 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 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 Feb 2017. 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. 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?
Collect questionnaire data from 150 HIPEC surgeons (time frame: Three months). 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 Feb 2017.