| CTRI Number |
CTRI/2024/09/073979 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Pre and post-operative Nerve Stimulation on bowel paralysis in patients undergoing large bowel surgery |
|
Scientific Title of Study
|
Effect of Peri-Operative Tibial Nerve Stimulation on Post Operative Paralytic Ileus in patient undergoing Colorectal surgery: An Observational Study. |
| Trial Acronym |
PANICS (Patients undergoing Colorectal Surgery with Nerve Stimulation) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Sahoo |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Department of General Surgery,
All India Institute of Medical Sciences (AIIMS),
Sijua,
Patrapada,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
dr.ashoksahoo2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Kulshrestha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Department of General Surgery,
All India Institute of Medical Sciences (AIIMS),
Sijua,
Patrapada,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
riyakul98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Sahoo |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Department of General Surgery,
All India Institute of Medical Sciences (AIIMS),
Sijua,
Patrapada,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
dr.ashoksahoo2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery,
All India Institute of Medical Sciences (AIIMS),
Sijua,
Patrapada,
Bhubaneswar,
Odisha,
India,
Pin- 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS |
| Address |
Department of General Surgery,
All India Institute of Medical Sciences (AIIMS),
Sijua,
Patrapada,
Bhubaneswar,
Odisha,
India,
Pin- 751019 |
| 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 Ashok Kumar Sahoo |
All India Institute of Medical Sciences (AIIMS) |
Department of General Surgery,
Unit-2,
Room No- 62
Khordha
ORISSA |
09655653969
dr.ashoksahoo2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, All India Institute of Medical Sciences, Bhubaneswar |
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 |
| Intervention |
Peri-Operative Tibial Nerve Stimulation |
Tibial nerve stimulation will be done using a nerve stimulator. The generator will be connected to a transcutaneous, positive stick-on electrocardiograph-type electrode with foam backing placed over the posterior tibial nerve, immediately behind the malleolus where the tibial nerve is most superficial, and a ground pad will be placed on the calf about 10 cm above, so as not to compromise a patient’s mobilisation. The stimulus to be used will be 200 ms Pulse, frequency of 20 Hz, and amplitude of 10 mA for 30 Minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient admitted to the Department of General Surgery and undergoing any Elective Laparoscopic / Open colorectal surgery – Resection and Anastomosis (Both Benign and Malignant)
2.Patient undergoing stoma reversal (Hartman, End/loop colostomy) |
|
| ExclusionCriteria |
| Details |
1.Patients of Chronic inflammatory bowel disease
2.Patient with documented irritable bowel syndrome
3.Surgical History of risk of damage to Vagal Nerve (Like Gastrectomy)
4.Taking medication which will alter the metabolism of acetylcholine
5.Patient with an intact pacemaker
6.Patient with diagnosed Peripheral Neuropathy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Passage of first flatus in the postoperative period |
in terms of post-operative days (e.g: day 1, day 2 etc. ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of passage of stools & appearance of bowel sounds
2.Length of postoperative hospital stay
3.Episodes of vomiting
4.Nasogastric tube (re)insertion
5.Any complications related to the use of the TTNS-Patch related allergy,Burns from electrodes |
in terms of post-operative days (e.g: day 1, day 2 etc. ) |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
21/09/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aims and Objectives of the study: Primary: To assess the efficacy of transcutaneous posterior tibial nerve stimulation in the recovery of bowel function Secondary: To assess the safety and feasibility of posterior tibial nerve stimulation in a perioperative setting Inclusion and Exclusion Criteria: Inclusion Criteria- - Age 18 – 75 Years of age
- Patient admitted to the Department of General Surgery and undergoing any Elective Laparoscopic / Open colorectal surgery – Resection and Anastomosis (Both Benign and Malignant)
- Patient undergoing stoma reversal (Hartman, End / loop colostomy)
Exclusion Criteria – - Patient of Chronic Inflammatory bowel disease
- Patient with documented irritable bowel syndrome
- Surgical History of risk of damage to Vagal Nerve (Like Gastrectomy)
- Taking medication which will alter the metabolism of acetylcholine
- Patient with intact pacemaker
- Patient with diagnosed Peripheral Neuropathy
Methodology: Study Design: Observational study Study Period: 2024 to 2026 Sample size: 48 (Expected population standard deviation= 0.17 Employing t- distribution ot estimate sample size Confidence interval 95% Precision = 0.05) Reference: Dhand, NK. ,. & Khatkar, M.S. (2014). Statulator: An online statistical calculator Sample size calculator for estimating a single mean Methods: Recruitment: All the patients undergoing colorectal surgeries in the department of General Surgery, laparoscopic or open, All India Institute of Medical Sciences, Bhubaneswar. Blinding: No Intervention: Transcutaneous/ Percutaneous Tibial Nerve Stimulation Procedure Tibial nerve stimulation will be done using a nerve stimulator Site - The generator will be connected to a transcutaneous, positive stick-on electrocardiograph-type electrode with foam backing placed over the posterior tibial nerve, immediately behind the malleolus where the tibial nerve is most superficial, and a ground pad will be placed on the calf about 10 cm above, so as not to compromise a patient’s mobilization Amplitude - 200 ms Pulse, frequency of 20 Hz, and amplitude 10 mA Duration - 20 Minutes Timing - Stimulation the day before surgery once, 30 minutes Stimulation on the day of surgery, before surgery (at least 2 hours before surgery) Stimulation every day thrice after surgery until gastrointestinal function recovery Primary and Secondary Outcome: Primary Outcome - Time of passage of first flatus
Secondary Outcome - Time of passage of stools and appearance of bowel sounds
- Length of postoperative hospital stay
- Episodes of vomiting
- Nasogastric tube (re)insertion
- Any complications related to the use of TTNS-Patch related allergy, burns from electrodes
|