Postoperative CarePhase 3NCT01084070
Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
A Phase 3 study testing Early oral feeding and Traditional Care in people with Postoperative Care, run by Hospital General de Agudos "Dr. Cosme Argerich" at 1 site in Argentina.
Trial summary
The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Early oral feeding and Traditional Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 3
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 14 years after abdominal emergency surgery.
Who cannot join
- Lack of consensus of the patient
- Concurrent extra-abdominal surgery
- Short bowel or other clear indication of parenteral nutrition
- Inability to feed orally (eg, decreased level of consciousness)
- Interventional procedure
- Esophageal surgery
- Reoperations
- Pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.
- Conditions
- Postoperative Care
- Being tested
- Early oral feeding, Traditional Care
- Keywords
- early feeding, postoperative care, emergency surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral feedingOther
Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
Traditional CareOther
They will have nasogastric tube and restriction of oral intake until the first sign of restoration of intestinal transit (first flatus or stool, whichever comes first). Since then withdrew nasogastric tube and liquid diet starts within 24 hours, then continues with soft diet.
| Study group | Role | What they receive |
|---|---|---|
| Early oral feeding | Experimental | Not described Receives: Other: Early oral feeding |
| Traditional Care | Active comparator | Not described Receives: Other: Traditional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".
Measured: At 30 days or at discharge
Secondary outcomes (4)
Gastrointestinal leaks
"the leak of luminal contents from a surgical join between two hollow viscera or from surgical repair of continuity solution. The luminal contents may emerge either through the wound or at the drain site, or they may collect near the anastomosis or rapair, causing fever, abscess, septicaemia, metabolic disturbance and/or multiple-organ failure. The escape of luminal contents intoan adjacent localised area, detected by imaging, in the absence of clinical symptoms and signs should be recorded as a subclinical leak"
Measured: At 30 days or at discharge
Time to resume bowel functions
Time from surgery to the first flatus or deposition, whatever occurs first
Measured: At 30 days or at discharge
Oral diet intolerance
The appearance of vomits or abdominal pain after diet
Measured: At 30 days or at discharge
Postoperative hospital stay
Postoperative hospital stay
Measured: At 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Agudos "Dr. Cosme Argerich"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich"
- Investigators
- Roberto F Klappenbach, MD, Principal investigator, Argerich Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084070
- Sponsor's protocol ID
- ARGERICH1
- Status last verified
- Jun 2012
- First submitted
- 9 Mar 2010
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodriguez J, Oria A. Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg. 2013 Oct;37(10):2293-9. doi: 10.1007/s00268-013-2143-1.
PubMed 23807124
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01084070
- Acronym / sponsor ID
- ARGERICH1
- Conditions
- Postoperative Care
- Keywords
- early feeding, postoperative care, emergency surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Hospital General de Agudos "Dr. Cosme Argerich"University, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Mar 2010 (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 traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding | Experimental | Other: Early oral feeding |
| Traditional Care | Active comparator | Other: Traditional Care |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 14 years after abdominal emergency surgery.
Key exclusion criteria (8 listed)
- Lack of consensus of the patient
- Concurrent extra-abdominal surgery
- Short bowel or other clear indication of parenteral nutrition
- Inability to feed orally (eg, decreased level of consciousness)
- Interventional procedure
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 |
|---|---|---|
| Early oral feedingWithin 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated. | Other | Early oral feeding |
| Traditional CareThey will have nasogastric tube and restriction of oral intake until the first sign of restoration of intestinal transit (first flatus or stool, whichever comes first). Since then withdrew nasogastric tube and liquid diet starts within 24 hours, then continues with soft diet. | Other | Traditional Care |
Primary outcome
Postoperative Complications
Time frame: At 30 days or at discharge
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".
4 secondary outcomes
Gastrointestinal leaks
Time frame: At 30 days or at discharge
Time to resume bowel functions
Time frame: At 30 days or at discharge
Oral diet intolerance
Time frame: At 30 days or at discharge
Postoperative hospital stay
Time frame: At 90 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 12 Jun 2012.
- Derived from this study: PubMed 23807124Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodriguez J, Oria A. Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg. 2013 Oct;37(10):2293-9. doi: 10.1007/s00268-013-2143-1.
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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.
Roberto F Klappenbach, MD principal investigator
Argerich Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early oral feeding and Traditional Care in people with Postoperative Care, run by Hospital General de Agudos "Dr. Cosme Argerich" at 1 site in Argentina.
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 8 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 12 Jun 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 Argentina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Complications (time frame: At 30 days or at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084070, which also lists 1 linked publication.
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 12 Jun 2012.