| CTRI Number |
CTRI/2025/10/096302 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NERVE STIMULATION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Tibial Nerve Stimulation to Improve Bowel Function After After Surgery - A Randomised Trial. |
|
Scientific Title of Study
|
EFFECT OF TRANSCUTANEOUS TIBIAL NERVE
STIMULATION (TTNS) IN PATIENTS UNDERGOING
BOWEL SURGERY FOR EARLY RECOVERY OF BOWEL
FUNCTION: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
TTNS-BOOST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHINAV KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
A3B3 WARD ROOM NO-310 SURGICAL BLOCK ,AIIMS DELHI
South
DELHI
110029
India |
| Phone |
9065971958 |
| Fax |
|
| Email |
kumarabhinav906597@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NELSON T |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
4th FLOOR ,ROOM NO-427 SURGICAL BLOCK ,AIIMS DELHI
South
DELHI
110029
India |
| Phone |
9789589298 |
| Fax |
|
| Email |
nelson.mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHINAV KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
A3B3 WARD ROOM NO-310 SURGICAL BLOCK ,AIIMS DELHI
South
DELHI
110029
India |
| Phone |
9065971958 |
| Fax |
|
| Email |
kumarabhinav906597@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Abhinav Kumar |
AIIMS DELHI |
A3B3 WARD ROOM NO-310 SURGICAL BLOCK
South
DELHI |
9065971958
Kumarabhinav906597@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR PG RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
STANDARD POST OPERATIVE CARE |
early mobilization, intravenous fluids,
analgesics, and gradual re introduction of oral feeds, as per institutional ERAS Protocol.
No sham stimulation will be applied (to avoid ethical concerns) |
| Intervention |
TRANSCUTANEOUS TIBIAL NERVE STIMULATION (TTNS) |
The active (negative) electrode is placed approximately 5 cm above the medial malleolus, posterior to the tibia, along the course of the posterior tibial nerve. The reference (positive) electrode is positioned about 10 cm above the active electrode on the same leg. Stimulation is delivered at a frequency of 20 Hz with a pulse width of 200 microseconds, based on protocols from Fujii et al. (2020) and related colorectal studies. The intensity is gradually increased until either a visible flexion of the toes or a mild tingling sensation over the sole of the foot is observed, ensuring that the stimulation remains comfortable and painless. The stimulation is administered thrice daily, with each session lasting 30 minutes, starting from 6 hours to 72 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Elective and Emergency Bowel Surgery (small or large
bowel resection and anastomosis for both Benign and
Malignant).
Stoma Reversal.
ASA Physical Status (I-III).
Give written informed consent. |
|
| ExclusionCriteria |
| Details |
Known Peripheral Neuropathy (which might affect tibial
nerve stimulation).
Presence of Cardiac Pacemaker or Implantable
Defibrillator.
Chronic Gastrointestinal motility Disorders (Gastroparesis.
Chronic intestinal pseudo-obstruction IBS).
Drugs(cholinergic)
Stoma formation
Refusing to Participate. |
|
|
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 |
| Time(hours) to first documented bowel sound |
Time(hours)- 6 HRS TO 72 HRS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first passage of flatus (hours).
Time to first passage of stool (hours).
Length of hospital Stay (days).
Incidence of Complications due to TTNS. |
Time(hours)- 6 HRS TO 72 HRS. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="2"
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 (POl), a frequent yet often overlooked consequence of abdominal surgery, is marked by sluggish or absent bowel movement that delay recovery and prolong hospitalization. This not only escalates healthcare cost but also increase risk of serious complications. Emerging as a promising non-invasive therapy, transcutaneous neuromodulation offer a novel approach to tackle POI by enhancing parasympathetic activity, dampening sympathetic overdrive and stimulating coordinated colonic contractions. By accelerating gut recovery this technique hold potential to reduce morbidity, shorten hospital stay improve postoperative quality of life,even decrease local inflammation within gut wall -making a compelling intervention worth exploring. |