| CTRI Number |
CTRI/2021/10/037054 [Registered on: 04/10/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of TENS on recovery of gastrointestinal function after abdominal surgery- a randomized controlled trial |
|
Scientific Title of Study
|
The effect of transcutaneous electrical nerve stimulation on recovery of gastrointestinal motility after exploratory laparotomy- a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik N |
| Designation |
Post Graduate resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Dr Karthik N
s/o Narasimhappa
Post Graduate resident
Department of General Surgery
OPD block, 5th floor block-B, Room no 520
AIIMS, Jodhpur- 324005
Basni, second phase
Dr Karthik N
s/o Narasimhappa
Post Graduate resident
Department of General Surgery
IPD block, 4th floor block-B,
AIIMS, Jodhpur- 324005
Basni, second phase
Jodhpur
RAJASTHAN
324005
India |
| Phone |
9900653594 |
| Fax |
|
| Email |
karthikn0912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Lodha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Dr Mahendra Lodha
Associate Professor
Department of General Surgery
Academic block, 1st floor, Room No 121
AIIMS, Jodhpur- 324005
Basni, second phase
r Mahendra Lodha
Associate Professor
Department of General Surgery
OPD block, 5th floor,block B Room No 518
AIIMS, Jodhpur- 324005
Basni, second phase
Jodhpur
RAJASTHAN
324005
India |
| Phone |
9900653594 |
| Fax |
|
| Email |
drmahendralodha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik N |
| Designation |
Post Graduate resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Dr Karthik N
s/o Narasimhappa
Post Graduate resident
Department of General Surgery
OPD block, 5th floor block-B, Room no 520
AIIMS, Jodhpur- 324005
Basni, second phase
Dr Karthik N
s/o Narasimhappa
Post Graduate resident
Department of General Surgery
IPD block, 4th floor block-B,
AIIMS, Jodhpur- 324005
Basni, second phase
Jodhpur
RAJASTHAN
324005
India |
| Phone |
9900653594 |
| Fax |
|
| Email |
karthikn0912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, AIIMS Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Kumar Puranik |
| Address |
Professor and HOD
Department of General Surgery
Academic block, 3rd floor, room no 357
AIIMS,Jodhpur-324005
Basni Second phase
|
| 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 |
| Karthik N |
All India Institute of Medical Sciences |
Department of General Surgery
OPD block, 5th floor, block-B
AIIMS, Jodhpur- 324005
Basni, second phase
Jodhpur
RAJASTHAN |
9900653594
karthikn0912@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
arm B , treated conventionally which includes pre and post surgical fasting, measures for gastrointestinal decompression (nasogastric aspiration), electrolytes stabilization, parenteral nutrition and antibiotics if needed will be given. This treatment will be terminated after 6 days or as soon as the patient had a satisfactory motion or passes stools per stoma |
| Intervention |
transcutaneous electrical nerve stimulation |
In arm A, immediately after surgery(within 30min), a portable TENS device comprising of 4 electrodes is applied to the patient. Two sterilized electrodes are attached at an equidistant position (3cms) parallel to the midline incision site on either side at adjacent dermatome levels. Simultaneously, two other electrodes are placed at S1-S2 level, parallel to the spinal column. The cables of the electrodes will be connected to the TENS device in the recovery room. The frequency will be set to 50 Hz and the intensity of electrical stimulation initially at 8-12 mA, reduced if not tolerated by patient. TENS will be given for 30 min every 3 hours. This stimulation will be terminated after 6 days or as soon as the patient had a satisfactory motion or passes stools per stoma. It also includes conventional treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 75 years
2. Patients undergoing exploratory laparotomy with midline incision of length greater than or equal to 5 cm
|
|
| ExclusionCriteria |
| Details |
1. Damage control surgeries
2. Patients with cardiac pacemakers
3. Patients with spinal cord stimulator or an intrathecal pump
4. Patients with dermatitis, skin infections and sensory impairment at site of application of adhesive electrodes
5. Surgical history of gastrectomy / esophagectomy (vagal nerve transection)
6. Irritable bowel syndrome
7. Inflammatory bowel disease
8. Patients with acute and chronic opioid use
9. Patients with preoperative severe mental illness
10. History of spinal injuries
11. Pancreatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time in hours to first post-operative passage of stools per rectum or per stoma starting from the time of randomization. |
Time in hours to first post-operative passage of stools per rectum or per stoma starting from the time of randomization on after 12 hours, 24 hours, 36 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Length of post-operative hospital stay
2.Nasogastric aspiration output volume monitoring in mL every 24 hours for 3 days
3.Time in hours to removal of Nasogastric tube starting from time of randomization.
4.Incidence of reinsertion of nasogastric tube.
5.Time to initiation of liquid diet and solid diet starting from the time of randomization.
6.Evaluation of pain intensity using visual analogue score in the immediate post-operative period and then at 24, 48 and 72 hours of treatment.
|
1.Length of post-operative hospital stay
2.Nasogastric aspiration output volume monitoring in mL every 24 hours for 3 days
3.Time in hours to removal of Nasogastric tube starting from time of randomization.
4.Incidence of reinsertion of nasogastric tube
5.Time to initiation of liquid diet and solid diet starting from the time of randomization.
6.Evaluation of pain intensity using visual analogue score in the immediate post-operative period and then at 24, 48 and 72 hours of treatment.
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/10/2021 |
| Date of Study Completion (India) |
06/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be published after completion of RCT |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
What our study adds?Most studies primarily focussed on use of TENS for controlling postoperative pain and few studies reported secondary effects on gastrointestinal system. Based on few studies, we hypothesize that use of TENS as a pre treatment may reduce incidence of postoperative ileus. |