Early FeedingNCT01028807
Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
A study testing Early feeding and 5 day fasting in people with Early Feeding and Bowel Anastomosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
Purpose: To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children. Methods: Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Early Feeding, Bowel Anastomosis
- What is being tested?
- Early feeding and 5 day fasting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2003to Nov 2004
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients between the ages of 1 month to 18 years old that required elective laparotomy with a distal elective bowel anastomosis (ileum and colon).
Who cannot join
- Proximal and non elective anastomosis
- High risk groups:
- Newborns
- Upper gastrointestinal tract anastomosis (esophagus, gastric, duodenal or jejunal)
- Bilious-digestive or rectal anastomosis
- Immunosuppressed patients
Show all 10Show fewer
- Gastrostomy or any pre anastomotic derivation
- Multiple anastomoses
- Chronic intestinal obstruction
- Patients who did not complete the minimum POP follow up of one month.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:
To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children.
Read more
Methods:
Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES:
Demographic characteristics, operative time, anastomosis placement,
Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to:
- Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started.
- Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.
- Conditions
- Early Feeding, Bowel Anastomosis
- Being tested
- Early feeding, 5 day fasting
- Keywords
- Early feeding, Bowel anastomosis, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feedingOther
after 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated.
5 day fastingOther
Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.
| Study group | Role | What they receive |
|---|---|---|
| 1. Experimental group: Early feeding: | Experimental | After 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated. Receives: Other: Early feeding |
| Control group : Obligatory 5 day fasting | Active comparator | Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards. Receives: Other: 5 day fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.
Measured: First 5 postoperative days
Secondary outcomes (1)
Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death
Measured: First 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJun 2003
- Primary completionMay 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Early FeedingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Investigators
- ROBERTO DAVILA-PEREZ, SURGEON, Principal investigator, HOSPITAL INFANTIL DE MEXICOEDUARDO BRACHO-BLANCHET, SURGEON, Study chair, HOSPITAL INFANTIL DE MEXICOJOSE MANUEL TOVILLA-MERCADO, SURGEON, Study chair, HOSPITAL INFANTIL DE MEXICOPABLO LEZAMA-DEL-VALLE, SURGEON, Study chair, HOSPITAL INFANTIL DE MEXICOGUSTAVO VARELA-FASCINETTO, SURGEON, Study chair, HOSPITAL INFANTIL DE MEXICOJAIME NIETO-ZERMEÑO, SURGEON, Study chair, HOSPITAL INFANTIL DE MEXICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028807
- Sponsor's protocol ID
- robdape2
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gokpinar I, Gurleyik E, Pehlivan M, Ozcan O, Ozaydin I, Aslaner A, Demiraran Y, Gultepe M. [Early enteral and glutamine enriched enteral feeding ameliorates healing of colonic anastomosis: experimental study]. Ulus Travma Acil Cerrahi Derg. 2006 Jan;12(1):17-21. Turkish.
PubMed 16456746Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
PubMed 7618972Seenu V, Goel AK. Early oral feeding after elective colorectal surgery: is it safe. Trop Gastroenterol. 1995 Oct-Dec;16(4):72-3.
PubMed 8854962Senkal M, Mumme A, Eickhoff U, Geier B, Spath G, Wulfert D, Joosten U, Frei A, Kemen M. Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients. Crit Care Med. 1997 Sep;25(9):1489-96. doi: 10.1097/00003246-199709000-00015.
PubMed 9295822Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. doi: 10.1016/s0899-9007(02)00990-5.
PubMed 12431715Feo CV, Romanini B, Sortini D, Ragazzi R, Zamboni P, Pansini GC, Liboni A. Early oral feeding after colorectal resection: a randomized controlled study. ANZ J Surg. 2004 May;74(5):298-301. doi: 10.1111/j.1445-1433.2004.02985.x.
PubMed 15144242Lucha PA Jr, Butler R, Plichta J, Francis M. The economic impact of early enteral feeding in gastrointestinal surgery: a prospective survey of 51 consecutive patients. Am Surg. 2005 Mar;71(3):187-90.
PubMed 15869128Sangkhathat S, Patrapinyokul S, Tadyathikom K. Early enteral feeding after closure of colostomy in pediatric patients. J Pediatr Surg. 2003 Oct;38(10):1516-9. doi: 10.1016/s0022-3468(03)00506-2.
PubMed 14577078Pearl ML, Valea FA, Fischer M, Mahler L, Chalas E. A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol. 1998 Jul;92(1):94-7. doi: 10.1016/s0029-7844(98)00114-8.
PubMed 9649101Stewart BT, Woods RJ, Collopy BT, Fink RJ, Mackay JR, Keck JO. Early feeding after elective open colorectal resections: a prospective randomized trial. Aust N Z J Surg. 1998 Feb;68(2):125-8. doi: 10.1111/j.1445-2197.1998.tb04721.x.
PubMed 9494004Han-Geurts IJ, Hop WC, Kok NF, Lim A, Brouwer KJ, Jeekel J. Randomized clinical trial of the impact of early enteral feeding on postoperative ileus and recovery. Br J Surg. 2007 May;94(5):555-61. doi: 10.1002/bjs.5753.
PubMed 17443854
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01028807
- Acronym / sponsor ID
- robdape2
- Conditions
- Early Feeding, Bowel Anastomosis
- Keywords
- Early feeding, Bowel anastomosis, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- May 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 9 Dec 2009 (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.
Purpose:
To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children.
Methods:
Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES:
Demographic characteristics, operative time, anastomosis placement,
Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to:
- Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started.
- Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Experimental group: Early feeding: | Experimental | Other: Early feedingAfter 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated. |
| Control group : Obligatory 5 day fasting | Active comparator | Other: 5 day fastingObligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients between the ages of 1 month to 18 years old that required elective laparotomy with a distal elective bowel anastomosis (ileum and colon).
Key exclusion criteria (10 listed)
- Proximal and non elective anastomosis
- High risk groups:
- Newborns
- Upper gastrointestinal tract anastomosis (esophagus, gastric, duodenal or jejunal)
- Bilious-digestive or rectal anastomosis
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 feedingafter 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated. | Other | 1. Experimental group: Early feeding: |
| 5 day fastingObligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards. | Other | Control group : Obligatory 5 day fasting |
Primary outcome
Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.
Time frame: First 5 postoperative days
1 secondary outcome
Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death
Time frame: First 30 postoperative 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 10 Dec 2009.
- Background: PubMed 16456746Gokpinar I, Gurleyik E, Pehlivan M, Ozcan O, Ozaydin I, Aslaner A, Demiraran Y, Gultepe M. [Early enteral and glutamine enriched enteral feeding ameliorates healing of colonic anastomosis: experimental study]. Ulus Travma Acil Cerrahi Derg. 2006 Jan;12(1):17-21. Turkish.
- Background: PubMed 7618972Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
- Background: PubMed 8854962Seenu V, Goel AK. Early oral feeding after elective colorectal surgery: is it safe. Trop Gastroenterol. 1995 Oct-Dec;16(4):72-3.
- Background: PubMed 9295822Senkal M, Mumme A, Eickhoff U, Geier B, Spath G, Wulfert D, Joosten U, Frei A, Kemen M. Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients. Crit Care Med. 1997 Sep;25(9):1489-96. doi: 10.1097/00003246-199709000-00015.
- Background: PubMed 12431715Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. doi: 10.1016/s0899-9007(02)00990-5.
- Background: PubMed 15144242Feo CV, Romanini B, Sortini D, Ragazzi R, Zamboni P, Pansini GC, Liboni A. Early oral feeding after colorectal resection: a randomized controlled study. ANZ J Surg. 2004 May;74(5):298-301. doi: 10.1111/j.1445-1433.2004.02985.x.
- Background: PubMed 15869128Lucha PA Jr, Butler R, Plichta J, Francis M. The economic impact of early enteral feeding in gastrointestinal surgery: a prospective survey of 51 consecutive patients. Am Surg. 2005 Mar;71(3):187-90.
- Background: PubMed 14577078Sangkhathat S, Patrapinyokul S, Tadyathikom K. Early enteral feeding after closure of colostomy in pediatric patients. J Pediatr Surg. 2003 Oct;38(10):1516-9. doi: 10.1016/s0022-3468(03)00506-2.
- Background: PubMed 9649101Pearl ML, Valea FA, Fischer M, Mahler L, Chalas E. A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol. 1998 Jul;92(1):94-7. doi: 10.1016/s0029-7844(98)00114-8.
- Background: PubMed 9494004Stewart BT, Woods RJ, Collopy BT, Fink RJ, Mackay JR, Keck JO. Early feeding after elective open colorectal resections: a prospective randomized trial. Aust N Z J Surg. 1998 Feb;68(2):125-8. doi: 10.1111/j.1445-2197.1998.tb04721.x.
- Background: PubMed 17443854Han-Geurts IJ, Hop WC, Kok NF, Lim A, Brouwer KJ, Jeekel J. Randomized clinical trial of the impact of early enteral feeding on postoperative ileus and recovery. Br J Surg. 2007 May;94(5):555-61. doi: 10.1002/bjs.5753.
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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 DAVILA-PEREZ, SURGEON principal investigator
HOSPITAL INFANTIL DE MEXICO
EDUARDO BRACHO-BLANCHET, SURGEON study chair
HOSPITAL INFANTIL DE MEXICO
JOSE MANUEL TOVILLA-MERCADO, SURGEON study chair
HOSPITAL INFANTIL DE MEXICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding and 5 day fasting in people with Early Feeding and Bowel Anastomosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
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 10 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 10 Dec 2009. 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 Mexico. 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?
Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. (time frame: First 5 postoperative days). 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 NCT01028807, which also lists 11 linked publications.
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 10 Dec 2009.