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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

August 20, 2008
August 21, 2008
October 2005
March 2007   (final data collection date for primary outcome measure)
To be able to tolerate early enteral feed [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739271 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Early Enteral Feeding After Intestinal Anastomosis
Early Enteral Feeding After Intestinal Anastomosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Intestinal Anastomosis
  • Other: Early feeding
  • Other: late feeding after bowel sounds return
    Traditional method
  • Active Comparator: Study arm
    Early enteral feed 48 hours after abdominal surgery
    Intervention: 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.
    Intervention: Other: late feeding after bowel sounds return
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
December 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00739271
RK2
No
Dr. Rajeev Kapoor, CMC Hospital
Christian Medical College and Hospital, Ludhiana, India
Not Provided
Study Chair: Rajeev Kapoor, MS CMC Hospital
Principal Investigator: Prerna Gupta, MS CMC Hospital
Christian Medical College and Hospital, Ludhiana, India
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP