| CTRI Number |
CTRI/2024/04/065139 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Application of abdominal binder after incisional hernia surgery] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of postoperative abdominal binder on outcomes of open incisional hernia repair |
|
Scientific Title of Study
|
Role of postoperative abdominal binder on outcomes of open incisional hernia repair in a tertiary care institute |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashesh Kumar Jha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Room no.-306
Department of General Surgery
AIIMS Patna
Bihar Danapur
Patna
Bihar Patna BIHAR 801505 India |
| Phone |
9582199339 |
| Fax |
|
| Email |
asheshjha04@gmil.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ashesh Kumar Jha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Room - 306
Department of General Surgery
AIIMS Patna
Bihar Danapur
Patna
Bihar
BIHAR 801505 India |
| Phone |
9582199339 |
| Fax |
|
| Email |
asheshjha04@gmil.com |
|
Details of Contact Person Public Query
|
| Name |
Ashesh Kumar Jha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Room - 306
Department of General Surgery
AIIMS, Patna
Bihar Danapur
Patna
Bihar
BIHAR 801505 India |
| Phone |
9582199339 |
| Fax |
|
| Email |
asheshjha04@gmil.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
AIIMS, Patna, Bihar - 801505 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of General Surgery
AIIMS, Patna
Phulwarisharif
Bihar - 801505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashesh Kumar Jha |
AIIMS, Patna |
Department of General Surgery, AIIMS, Patna Patna BIHAR |
09582199341
asheshjha04@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee, AII India Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
After open incisional hernia repair no abdominal binder will be applied |
In this group of participants after incisional hernia repair no abdominal binder will be applied |
| Intervention |
Application of abdominal binder after open incisional hernia repair |
Patients undergoing incisional hernia repair meeting the inclusion criteria and willing to participate in this study and based on group allocation will be offered abdominal binder after open incisional hernia surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Midline incisional hernia with a defect size of up to 10cms
• ASA I and II
• Age group 18 to 65 years
|
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 65 years old
BMI more than 30
Diabetes, COPD and known immunosuppressive conditions
Loss of domain and recurrent hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative seroma formation in both the groups |
24 hours drain output as long as drain remains in situ and thereafter at one month by USG abdomen |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- The length of hospital stays in days
- To measure the pain in both group at various time interval by applying VAS
- Patient comfort by Carolina comfort scale and ability to mobilize by functional ambulation categories at different time intervals in patients with and without use of abdominal binder after open incisional hernia repair
|
Hourly and daily based on outcomes |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2024 |
| 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="6" Days="15" |
|
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
|
Incisional hernia repair is a common surgical procedure, which usually accounts for 15 to 18% of all surgeries. Both minimally invasive or open surgical methods of hernia repair has been described. Understandably, minimally invasive approach causes less pain, lower surgical site occurrences and post-operative discomfort in comparison to the open surgical technique of incisional hernia repair. Moreover, these relatively common post-operative sequalae of open hernia repair can increase the post operative morbidity and prolong the hospital stay of the patients. Apart from prescribing routine postoperative care, some alternative methods are also practiced to minimize the chances of postoperative pain, surgical site occurrences and patient’s discomfort. One such practice is the application of elastic abdominal binders. It’s beneficial effect after midline laparotomies is being reported by the various studies. Abdominal binders are proposed to reduce stress on wounds, abdominal muscle actions during mobilization and increase vascularity to the incision site and mitigate surgical site edema (seroma) There is a paucity of literature highlighting the beneficial effects of elastic abdominal binder after open incisional hernia repair. Therefore, we are conducting this study to evaluate the role of abdominal binder in cases of open incisional hernia repair. |