| CTRI Number |
CTRI/2020/06/026210 [Registered on: 29/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency(SMILE Trial) |
|
Scientific Title of Study
|
Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency- A prospective,double blind multicentric, randomized controlled trial |
| Trial Acronym |
SMILE Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 402, Academic Block,AIIMS Bhubaneswar,Sijua,Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 402,Academic block,AIIMS Bhubaneswar,Sijua,Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Room No 402,Academic block,AIIMS Bhubaneswar,Sijua,Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9711090814 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua,Patrapada,Bhubaneswar,Orissa |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Bhubaneshwar |
AIIMS Bhubaneshwar, Sijua, Patrapada, Bhubaneshwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Kumar |
AIIMS Bhubaneswar |
Sijua,Patrapada,Bhubaneswar
Khordha
ORISSA |
9711090814
drpkushwaha@gmail.com |
| Dr Subodh Kumar |
AIIMS,New Delhi |
JPNATC,AIIMS,Rajnagar,New Delhi
South
DELHI |
9810202776
subodh6@gmail.com |
| Dr G Balasubramanian |
JIPMER |
Gorimedu,Dhanvantari Nagar,Puducherry
Pondicherry
PONDICHERRY |
9894493841
drbala18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
| AIIMS, New Delhi |
Approved |
| JIPMER |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (2) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (3) ICD-10 Condition: K669||Disorder of peritoneum, unspecified, (4) ICD-10 Condition: K650||Generalized (acute) peritonitis, (5) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
mass closure of emergency midline abdominal incision |
mass closure of emergency midline abddominal incision ith interuppted PDS or Nylon sutures |
| Intervention |
Small bite continuous suture closure of emergency midline laprotomy |
Small bite continuous suture closure of emergency laprotomy with 2-0 PDS suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
any patient with age more than 18 years, undergoing emergency midline laprotomy |
|
| ExclusionCriteria |
| Details |
Patients with previous abdominal incisions/scar H/O Chronic cough
ASA(American society of Anesthesiology) grade 3 & 4 Refractory hypotension,
Septic shock
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Incisional Hernia at thirty- six months. |
Development of Incisional Hernia at thirty- six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Surgical site infection and Burst abdomen in post-operative period. 2.Quality of life at 3 months, 6 months and one year and three year. |
1 year and 3 year |
|
|
Target Sample Size
|
Total Sample Size="680"
Sample Size from India="680"
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 1 |
|
Date of First Enrollment (India)
|
15/07/2020 |
| 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="6"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet recruited |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Incisional hernia causes significant morbidity and decreased quality of life postoperatively. Treatment for repair is costly. Apart from patient-related factors like malnutrition, obesity, smoking and post-operative wound infection, the surgical technique of wound closure and suture material used could potentially be a major determinant of postoperative incisional Hernia. According to European hernia society (EHS) guideline, small bite continuous suture with 2-0 PDS is recommended for the closure of elective midline laparotomy incision.“TheSTICH Trialâ€, conducted on 560 patients in the Netherlands, over a period of three years, in the patients undergoing elective laparotomy in the surgical and gynecological department has shown almost a 50% reduction in the rate of incisional hernia (21% to 13%). Only thirteen RCTs have included both emergency and elective midline laparotomies but none of them reported outcome data separately for emergency or elective subgroup. Only one study by Agrawal et al has compared only emergency laparotomies. But they have compared two different types of sutures namely absorbable and non- absorbable. We could not find any good quality of literature comparing small bite suture technique to mass closure in midline laparotomy incision in an emergency. A similar view was mentioned by both MATCH review and European hernia society and hence they cannot frame a guideline on emergency wound closure technique. Considering the incidence of incisional hernia as 15–20% of total laparotomies, which increases up to 35% in emergency laparotomies, incisional hernia should be considered as a major cause of morbidity. High cost associated with the repair is another major concern. Small bite suture closure technique is now proposed as a standard procedure in elective surgeries. We plan to undertake this study for emergency midline laparotomies, as there are no guidelines for the same. 1.Primary objective : Development of Incisional Hernia at thirty- six months. 2. Secondary objective : .Surgical site infection and Burst abdomen in the post-operative period. Quality of life at 3 months, 6 months and one year and three year |