| CTRI Number |
CTRI/2019/02/017688 [Registered on: 15/02/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study for comparison of two types of suturing of abdominal wall muscle sheath in closing after emergency surgery for intestinal perforation |
|
Scientific Title of Study
|
Comparison of Interrupted-X technique closure versus Conventional continuous closure of rectus sheath - A randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BALAJI C |
| Designation |
Post graduate in M S General Surgery |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Ward 3A, Department of General Surgery,Maulana Azad Medical College and associated Lok Nayak Hospital.
New Delhi
DELHI
110002
India |
| Phone |
9994237363 |
| Fax |
|
| Email |
drcbic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUSHANTO NEOGI |
| Designation |
Professor in Department of General Surgery |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room number 209, Second floor, B.L.Taneja block, Department of General Surgery, Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9968604384 |
| Fax |
|
| Email |
sushantoneogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BALAJI C |
| Designation |
Post graduate in M S General Surgery |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Ward 3A, Department of General Surgery,Maulana Azad Medical College and associated Lok Nayak Hospital.
New Delhi
DELHI
110002
India |
| Phone |
9994237363 |
| Fax |
|
| Email |
drcbic@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dean, Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dean Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi -110002 |
| 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 |
| BALAJI C |
Lok Nayak Hospital |
Department of General Surgery,Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi
New Delhi
DELHI |
9994237363
drcbic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional continuous technique of suturing of rectus sheath |
Conventional continuous technique of suturing of rectus sheath during abdominal wall closure of exploratory laparotomy for perforation peritonitis |
| Intervention |
Interrupted - X technique of suturing of rectus sheath |
Interrupted - X technique of suturing of rectus sheath during abdominal wall closure of exploratory laparotomy for perforation peritonitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparotomy for perforation peritonitis in emergency settings by midline incision |
|
| ExclusionCriteria |
| Details |
History of previous midline laparotomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PRIMARY OUTCOME -Incidence of wound dehiscence (Post-operative separation of musculo-aponeurotic layers of abdominal wall within 10 days of surgery). |
Patient will be assessed during postoperative period till discharge, and subsequent follow up at 2weeks and 1month of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SECONDARY OUTCOME- Duration of hospital stay |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
18/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/08/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized control study conducted in general Surgery department of Lok Nayak Hospital, comparing the interrupted - X suturing technique with conventional continuous closure of rectus sheath in patients undergoing exploratory laparotomy by midline incision for perforation peritonitis. |