- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906289
Resumption of Enteral Feeding After Bowel Anastomosis
March 25, 2025 updated by: Dr Saeed Sarwar, Khyber Teaching Hospital
Comparison of Early Versus Late Resumption of Enteral Feeding After Small Bowel Anastomosis.
Resumption of oral feeding after small intestine surgery is a matter of controversy .Some surgeons advocate early resumption while others don't.early
feeding is initiated as soon as the patient recovers from effects of anaesthesia, while late resumption is started after 24-48 hours after surgery.Recent studies and guidelines suggest early feeding.
The aim of this study is to compare the early and late resumption of oral feeding.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saeed Sarwar, MBBS
- Phone Number: +92342 0973863
- Email: saeedkmc2020@gmail.com
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Recruiting
- Khyber Teaching Hospital
-
Contact:
- Saeed Sarwar, MBBS
- Phone Number: +923420973863
- Email: saeedkmc2020@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All patients undergoing small bowel anastomosis for any indication in elective setting
- Patients of age between 15 to 65 years.
- All genders
Exclusion Criteria:
- Patient using glucocorticoids or other immunosuppressive drugs
- non conseting individuals
- Patient having history of gastrectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early group
Early group includes patients in whom enteral feeding is resumed within 24 hours once fully conscious from effects of anesthesia
|
Patients will be subjected to resumption of enteral feeding within 24 hours of surgery
Patients will be subjected to late resumption of enteral feeding after 24 to 48 hours of surgery
|
|
Experimental: Late group
Late group includes patients in whom enteral feeding is started 24-48 hours after recovery from anesthesia
|
Patients will be subjected to resumption of enteral feeding within 24 hours of surgery
Patients will be subjected to late resumption of enteral feeding after 24 to 48 hours of surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to passage of stool/flatus
Time Frame: Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.
|
Time to passage of stool or flatus after surgery ,as reported by the patient or noticed by nurse.Time will be measured in day(s).
|
Upto 2 weeks from surgery .From the time of surgery to passage of stool or flatus or death due to any cause, whichever comes first.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital stay
Time Frame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
|
Number of days spent at hospital from time of surgery till discharge from hospital
|
Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
|
|
Vomiting
Time Frame: Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
|
if vomiting occured or not during time of study.
|
Upto 50 weeks postoperatively ,From surgery to discharge or death , whichever comes first.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 25, 2025
First Posted (Actual)
April 2, 2025
Study Record Updates
Last Update Posted (Actual)
April 2, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 806/DME/KMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data about patients will not be shared due to confidentiality issues.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anastomotic Leak
-
Freek DaamsSAS InstituteRecruitingAnastomotic Leak | Anastomotic Leak Rectum | Anastomotic Complication | Anastomotic Leak Large IntestineNetherlands
-
Fundación Pública Andaluza para la gestión de la...RecruitingAnastomotic Complication | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineSpain
-
Sir Ganga Ram HospitalCompletedAnastomotic Leak Rectum | Anastomotic Leak Large Intestine | Colo-rectal SurgeryIndia
-
Amsterdam UMC, location VUmcActive, not recruitingIntraoperative Awareness | Anastomotic Leak Rectum | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineBelgium, Netherlands
-
Vanderbilt University Medical CenterFujiFilm HealthCare Americas CorporationNot yet recruitingAnastomotic Leak Rectum | Anastomotic Leak Large Intestine
-
Amsterdam UMC, location VUmcRecruitingAnastomotic Leak RectumNetherlands, Italy, United Kingdom, Spain, France
-
National Research Oncology and Transplantology...RecruitingAnastomotic Leak Rectum | Anastomotic Leak Large IntestineKazakhstan
-
University Hospital TuebingenCompletedAnastomotic Leak EsophagusGermany
-
Hospital Universitari de BellvitgeCompletedEsophageal Anastomotic LeakSpain
-
Mansoura UniversityCompletedPancreatic Anastomotic LeakEgypt
Clinical Trials on resumption of enteral feeding within 24 hours of surgery
-
Weifang Medical UniversityCompletedPostoperative Complications | Gynecologic NursingChina
-
Children's Memorial Health Institute, PolandNutricia FoundationUnknownEnteral Nutritional SupportPoland
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted
-
Jiang LiuRecruitingPostoperative Nausea and VomitingChina
-
Dongzhimen Hospital, BeijingBeijing Friendship Hospital; Beijing Tiantan Hospital; Guang'anmen Hospital of... and other collaboratorsUnknownStroke | Acute Ischemic Stroke | Acute Intracranial HemorrhageChina
-
University of TennesseeRecruitingPremature Infant Disease | VLBW - Very Low Birth Weight Infant | Extra Uterine Growth RestrictionUnited States
-
University of Southern DenmarkOdense University HospitalRecruiting
-
Beijing Anzhen HospitalNot yet recruitingCoronary Heart Disease | Acute Non-variceal Upper Gastrointestinal Hemorrhage
-
Central Hospital, Nancy, FranceCompleted