Early Enteral Feeding After Intestinal Anastomosis
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 20, 2008 | ||||||||
| Last Updated Date | August 21, 2008 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To be able to tolerate early enteral feed [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00739271 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Early Enteral Feeding After Intestinal Anastomosis | ||||||||
| Official Title ICMJE | Early Enteral Feeding After Intestinal Anastomosis | ||||||||
| Brief Summary | The concept of starting the patient on early enteral nutrition has been a topic of much interest and research in the past decade. It is gaining widespread acceptance worldwide as more and more studies are being conducted proving early enteral nutrition to be more physiological, to prevent morphologic and functional trauma related alterations of the gut and to modulate immune and inflammatory responses, and as being less expensive than total parenteral nutrition. Early enteral nutrition is a major component of the recently introduced post operative rehabilitative regimens. Early feeding has been shown to reduce the risk of any specific infection, mean length of hospital stay, anastomotic dehiscence, wound infection, pneumonia, intra abdominal abscesses. It leads to lower weight loss and early positive nitrogen balance. Hence, overall early enteral nutrition leads to reduced post operative morbidity and better patient outcome. The objective of this study was to study and compare the effects of early enteral feeding with those of conventional management in patients undergoing intestinal anastomosis; the end points being return of bowel activity, incidence of septic complications, length of hospital stay, weight loss and post operative morbidity. |
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| Detailed Description | Pre operatively, common parameters observed in both study and control groups were:
Post operatively, the patients in the study group were kept nil per orally for the first forty eight hours. The nasogastric tube was removed on the first post operative day invariably. After forty eight hours of surgery, subjects were started on sips of clear liquids orally; the amount was gradually increased as tolerated by the patient. The diet was stepped up to soft diet and to regular diet. A record was made of abdominal discomfort, pain or distension if experienced by the subject during feeding. Record was made of the following:
Patients in the control group were kept on maintenance intravenous fluids containing dextrose and saline. Nasogastric tube was removed and feeds were started orally as decided by the operating surgeon depending on the clinical condition of the patient and presence of bowel activity. Post operative records were made of the same parameters as in the study group. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Intestinal Anastomosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 82 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00739271 | ||||||||
| Other Study ID Numbers ICMJE | RK2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Rajeev Kapoor, CMC Hospital | ||||||||
| Study Sponsor ICMJE | Christian Medical College and Hospital, Ludhiana, India | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Christian Medical College and Hospital, Ludhiana, India | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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