Intestinal AnastomosisNCT00739271
Early Enteral Feeding After Intestinal Anastomosis
A study testing Early feeding and late feeding after bowel sounds return in people with Intestinal Anastomosis, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Intestinal Anastomosis
- What is being tested?
- Early feeding and late feeding after bowel sounds return
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing intestinal anastamosis on an elective or emergency basis
Who cannot join
- Re laparotomies
- Patients who are immunosuppressed
- Patients with renal failure
- Patients with spinal injuries
- Patients requiring critical care
- Pediatric patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Intestinal Anastomosis
- Being tested
- Early feeding, late feeding after bowel sounds return
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feedingOther
late feeding after bowel sounds returnOther
Traditional method
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | Early enteral feed 48 hours after abdominal surgery Receives: 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. Receives: Other: late feeding after bowel sounds return |
What is being measured
The primary outcome is the main question the study is designed to answer.
To be able to tolerate early enteral feed
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startOct 2005
- Primary completionMar 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Investigators
- Rajeev Kapoor, MS, Study chair, CMC HospitalPrerna Gupta, MS, Principal investigator, CMC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739271
- Sponsor's protocol ID
- RK2
- Status last verified
- Aug 2008
- First submitted
- 20 Aug 2008
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Enteral Feeding After Intestinal Anastomosis
- ClinicalTrials.gov ID
- NCT00739271
- Acronym / sponsor ID
- RK2
- Conditions
- Intestinal Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Other: Early feedingEarly enteral feed 48 hours after abdominal surgery |
| Control arm | Active comparator | Other: late feeding after bowel sounds returnTraditional 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing intestinal anastamosis on an elective or emergency basis
Key exclusion criteria (6 listed)
- Re laparotomies
- Patients who are immunosuppressed
- Patients with renal failure
- Patients with spinal injuries
- Patients requiring critical care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early feeding | Other | Study arm |
| late feeding after bowel sounds returnTraditional method | Other | Control arm |
Primary outcome
To be able to tolerate early enteral feed
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev Kapoor, MS study chair
CMC Hospital
Prerna Gupta, MS principal investigator
CMC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding and late feeding after bowel sounds return in people with Intestinal Anastomosis, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To be able to tolerate early enteral feed (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2008.