| CTRI Number |
CTRI/2025/05/087323 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efferent limb Enteral Stimulation before Ileostomy Closure and its effect on bowel activity |
|
Scientific Title of Study
|
Effect of Preoperative Efferent limb Enteral Stimulation on Ileostomy Closure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asjad Ahmad Siddiqui |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim university, Aligarh |
| Address |
Dept of surgery, JNMC, AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9889781349 |
| Fax |
|
| Email |
asjadasd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Atia Zaka Ur Rab |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim university, Aligarh |
| Address |
Dept of surgery, JNMC, AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
94576 13148 |
| Fax |
|
| Email |
drazrab@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asjad Ahmad Siddiqui |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim university, Aligarh |
| Address |
Dept of surgery, JNMC, AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9889781349 |
| Fax |
|
| Email |
asjadasd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
DEPARTMENT OF SURGERY, JNMCH, ALIGARH MUSLIM UNIVERSITY, ALIGARH, PIN-202002, UTTAR PRADESH, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Asjad Ahmad Siddiqui |
Jawaharlal Nehru Medical College |
Department of Surgery, JNMC, AMU, Aligarh
Aligarh
UTTAR PRADESH |
9889781349
asjadasd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z932||Ileostomy status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EFFERENT LIMB STIMULATION |
Patients in the study group will be trained to do daily stimulation of the
efferent stomal segment by using a thick solution (500 mL of physiological
saline mixed with 30 g of protein-enriched thickening agent) 2 weeks prior to planned
ileostomy closure. |
| Comparator Agent |
no efferent limb stimulation |
Patients in the control group will not be subjected to daily stimulation of the
defunctionalized stomal segment by using a thick solution. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient giving consent for their inclusion in the study.
2) Patients having ileostomy following emergency exploratory laparotomy
|
|
| ExclusionCriteria |
| Details |
Patient not giving the consent
Hemodynamically unfit patient
Patient undergoing ileostomy closure for elective laprotomy
H/O multiple abdominal surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| return of bowel activity |
at baseline, 24hr, 48hr, 72hr, 96hr and 120hr after sugery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| tolerence of oral feed |
2nd day, 3rd day, 4th day, 5th day & 6th days after surgery |
| length of hospital stay |
at 4th day, 5th day, 6 th day, 7th day, 8th day, 9th day & 10th day of surgery |
| compare protien status & biochemical markers( TSPAG,IL-6 & CRP) |
before stimulation, after stimulation & after ileostomy closure |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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 Yet Recruiting |
| 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
|
in this trial titled "Effect of Preoperative Efferent limb Enteral Stimulation on Ileostomy Closure" we will be studying effects of efferent limb stimulation prior to ileostomy closure on various post-op parameters. After informed consent patients wound be randomly assigned to 2 groups each undergoing ileostomy closure. Patients in the study group will be trained to do daily stimulation of the efferent stomal segment by using a thick solution (500 mL of physiological saline mixed with 30 g of protein-enriched thickening agent) 2 weeks prior to planned ileostomy closure. Patients in the control group will not be subjected to daily stimulation of the efferent stomal segment by using a thick solution. pateint will be kept under observation post-operatively, and parameters like time taken for return of normal bowel activity, tolerence of oral feed, length of hospital stay and levels of biochemical marker( TSPAG, IL-6 and CRP) will be compared between both groups.. |