Early Enteral Feeding After Intestinal Anastomosis

NCT00739271 | Completed

• 1 other identifier: RK2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Anastomosis

Outcome Measures

Primary Outcomes (1)

• To be able to tolerate early enteral feed

  48 hours

Study Arms (2)

Study arm

ACTIVE COMPARATOR

Early enteral feed 48 hours after abdominal surgery

Other: Early feeding

Control arm

ACTIVE COMPARATOR

Traditional treatment where patient is kept on a nasogastric drainage for a few days after abdominal surgery, wait for bowel sounds to appear and then start enteral feeds.

Other: late feeding after bowel sounds return

Interventions

Early feeding OTHER

Study arm

late feeding after bowel sounds return OTHER

Traditional method

Control arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing intestinal anastamosis on an elective or emergency basis

You may not qualify if:

• Re laparotomies
• Patients who are immunosuppressed
• Patients with renal failure
• Patients with spinal injuries
• Patients requiring critical care
• Pediatric patients

Sponsors & Collaborators

• Christian Medical College and Hospital, Ludhiana, India: lead

Study Sites (1)

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

Study Officials

• Rajeev Kapoor, MS

  CMC Hospital

  STUDY CHAIR

• Prerna Gupta, MS

  CMC Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: October 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 22, 2008

Record last verified: 2008-08

Locations

IN (1)