Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
82 participants
INTERVENTIONAL
2005-10-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study arm
Early enteral feed 48 hours after abdominal surgery
Early feeding
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.
late feeding after bowel sounds return
Traditional method
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early feeding
late feeding after bowel sounds return
Traditional method
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients who are immunosuppressed
* Patients with renal failure
* Patients with spinal injuries
* Patients requiring critical care
* Pediatric patients
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Christian Medical College and Hospital, Ludhiana, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CMC Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rajeev Kapoor, MS
Role: STUDY_CHAIR
CMC Hospital
Prerna Gupta, MS
Role: PRINCIPAL_INVESTIGATOR
CMC Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Christian Medical College and Hospital
Ludhiana, Punjab, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RK2
Identifier Type: -
Identifier Source: org_study_id