| CTRI Number |
CTRI/2026/03/106618 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trail to compare caffeine and lactulose to restore bowel function after general anesthesia - CAFLAC trail |
|
Scientific Title of Study
|
Oral caffeine versus lactulose for enhancing gastrointestinal recovery in patients after elective abdominal surgeries under general anesthesia - CAF-LAC TRAIL - A randomised controlled study |
| Trial Acronym |
CAF-LAC Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil B |
| Designation |
Academic Junior Resident 2nd year |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
Room no 101. department of general surgery. AIIMS GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6361158163 |
| Fax |
|
| Email |
nikhilchakravarthi794@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmendra kumar pipal |
| Designation |
Associate professor |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
Room no 101, Department of general surgery, AIIMS GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9602541730 |
| Fax |
|
| Email |
dr.dharmendrapipal2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil B |
| Designation |
Academic Junior Resident 2nd year |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
Room no 101, Department of general surgery, AIIMS GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6361158163 |
| Fax |
|
| Email |
nikhilchakravarthi794@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Gorakhpur, Gorakhpur, Uttar Pradesh, 273008, India |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil B |
| Address |
Room no 101, Department of general surgery ,AIIMS GORAKHPUR, Gorakhpur, India, 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil B |
AIIMS GORAKHPUR |
Room no 101,Department of General Surgery AIIMS GORAKHPUR, Gorakhpur
Gorakhpur
UTTAR PRADESH |
6361158163
nikhilchakravarthi794@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC COMMITTEE AIIMS GORAKHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K560||Paralytic ileus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Group (Group B – Lactulose) |
Participants randomized to the comparator arm will receive oral lactulose 15 mL twice daily. The first dose will be administered 6 hours after completion of elective abdominal surgery under general anesthesia, once the patient is clinically stable and able to tolerate oral intake. The medication will be continued twice daily until the first bowel movement occurs or for a maximum duration of 5 postoperative days, whichever occurs earlier. Standard postoperative care as per institutional protocol will be continued for all patients. |
| Intervention |
Intervention Group (Group A – Oral Caffeine) |
Participants randomized to the intervention arm will receive oral caffeine 100 mg twice daily. The first dose will be administered 6 hours after completion of elective abdominal surgery under general anesthesia, once the patient is clinically stable and able to tolerate oral intake. The medication will be continued twice daily until the first bowel movement occurs or for a maximum duration of 5 postoperative days, whichever occurs earlier. Standard postoperative care as per institutional protocol will be continued for all patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18–65 years
Undergoing elective abdominal surgery under general anesthesia
ASA physical status I–III
Able to tolerate oral intake postoperatively
Expected hospital stay more than 24 hours
Willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
History of inflammatory bowel disease
Patients undergoing bowel resection and anastomosis
Known allergy or intolerance to caffeine or lactulose
Patients on regular laxatives or prokinetics
Severe hepatic, renal, or cardiac dysfunction
Pregnant or lactating women
Patients with caffeine dependence (greater than 400 mg/day intake) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first bowel movement after surgery |
Measured in hours from the end of surgery until the first documented bowel movement, assessed up to 120 hours (5 days) postoperatively or until discharge, whichever occurs earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first flatus
Time to first stool passage
Time to tolerance of oral feeding
Duration of hospital stay |
assessed up to 120 hours postoperatively or until discharge |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative ileus is a common complication following elective abdominal surgery and is characterized by delayed return of gastrointestinal motility, abdominal distension, nausea, discomfort, and prolonged hospital stay. Several factors contribute to postoperative ileus, including bowel manipulation during surgery, anesthetic effects, inflammatory responses, sympathetic stimulation, and opioid use. Early restoration of gastrointestinal function is essential to improve postoperative recovery and reduce hospitalization. Caffeine, a methylxanthine compound, has been shown to stimulate gastrointestinal motility through antagonism of adenosine receptors and stimulation of enteric nervous system activity. Lactulose, a non-absorbable disaccharide, is commonly used as an osmotic laxative to promote bowel movement in postoperative patients. Although both agents are used to enhance bowel motility, direct comparison between oral caffeine and lactulose in postoperative gastrointestinal recovery has not been adequately studied. The CAFLAC Trial (Caffeine Versus Lactulose Trial) is a prospective randomized controlled trial conducted in the Department of General Surgery at AIIMS Gorakhpur. The study aims to compare the effectiveness of oral caffeine versus lactulose in enhancing gastrointestinal recovery in patients undergoing elective abdominal surgery under general anesthesia. The primary outcome will be time to first bowel movement, while secondary outcomes include time to first flatus, time to first stool passage, tolerance to oral feeding, and duration of hospital stay. |