Early Enteral Feeding After Intestinal Anastomosis

This study has been completed.
Sponsor:
Information provided by:
Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:
NCT00739271
First received: August 20, 2008
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Intestinal Anastomosis
Other: Early feeding
Other: late feeding after bowel sounds return

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Enteral Feeding After Intestinal Anastomosis

Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:
  • To be able to tolerate early enteral feed [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study arm
Early enteral feed 48 hours after abdominal surgery
Other: Early feeding
Active Comparator: Control arm
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
Traditional method

Detailed Description:

Pre operatively, common parameters observed in both study and control groups were:

  • Name
  • Age
  • Sex
  • Date of admission
  • Weight
  • Indication of surgery
  • Pre operative features of sepsis (whether present or not) which included temperature, pulse rate& total leukocyte count.

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:

  • Site of anastomosis
  • Type of anastomosis ( sutured / stapled )
  • Time of removal of nasogastric tube
  • Time of passage of flatus / stools post operatively
  • Time of appearance of bowel sounds
  • Features of sepsis which included temperature, pulse rate & total leukocyte count
  • Presence of wound infection
  • Weight on the fifth day of surgery, at the time of discharge
  • Date of discharge
  • Length of hospital stay

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Re laparotomies
  • Patients who are immunosuppressed
  • Patients with renal failure
  • Patients with spinal injuries
  • Patients requiring critical care
  • Pediatric patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739271

Locations
India
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Sponsors and Collaborators
Christian Medical College and Hospital, Ludhiana, India
Investigators
Study Chair: Rajeev Kapoor, MS CMC Hospital
Principal Investigator: Prerna Gupta, MS CMC Hospital
  More Information

No publications provided

Responsible Party: Dr. Rajeev Kapoor, CMC Hospital
ClinicalTrials.gov Identifier: NCT00739271     History of Changes
Other Study ID Numbers: RK2
Study First Received: August 20, 2008
Last Updated: August 21, 2008
Health Authority: India: Institutional Review Board

ClinicalTrials.gov processed this record on August 18, 2014