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CTRI Number  CTRI/2024/09/073802 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 18/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Are Wound Complications Following Emergency Laparotomy Related to Intra Abdominal Pressure? 
Scientific Title of Study   Intra-Abdominal Pressure Measurement as Predictor of Postoperative Wound Complications in the Patients Undergoing Emergency Laparotomy: A Prospective Observational Study 
Trial Acronym  NIL 
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  09655653969  
Fax    
Email  dr.ashoksahoo2010@gmail.com  
 
Details of Contact Person
Scientific 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  09655653969  
Fax    
Email  dr.ashoksahoo2010@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  09655653969  
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  
Name  Address 
NIL  NIL 
 
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 
IEC,AIIMS,BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K560||Paralytic ileus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients who underwent emergency laparotomy through a midline incision 
 
ExclusionCriteria 
Details  1.Patients with a history of prior abdominal surgery
2.Failed attempt at Foley catheterisation at admission
3.Trauma to urinary bladder
4.in whom the abdomen is not closed intentionally for a second look laparotomy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Relationship between IAP and postoperative wound healing in patients undergoing emergency laparotomy  IAP at admission, after completion of operation, and subsequently at an interval of 6 hours, 12 hours, 24 hours, 48 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Relationship between IAP & different procedures in emergency laparotomies with respect to wound healing
2.Relationship between IAP & different pathologies in emergency laparotomies with respect to wound healing 
In terms of Post Operative Days (e.g. POD 1, POD 2 etc.) 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "134"
Final Enrollment numbers achieved (India)="134" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/09/2024 
Date of Study Completion (India) 11/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Detailed information regarding the patient’s demographics (age, gender, and body mass index), hemodynamic status at admission, and clinical and biochemical evidence of organ failure will be noted. The operative details (intra-operative findings, type of operative procedure, duration of surgery, drain placement, and skin closure method), postoperative diagnosis, and postoperative wound complications (infection, dehiscence, development of incisional hernia) will be recorded. Measurement of intra-abdominal pressure: Non-invasive measurement of IAP in the form of intra-vesicular pressure will be carried out.

Measurement of intra-abdominal pressure: Non-invasive measurement of IAP in the form of intra-vesicular pressure will be carried out. Each patient was catheterised with a 15 Fr Foley catheter and the bladder will be emptied of urine. Then, 50 ml of saline was instilled into the bladder, and the catheter tubing will be clamped. After one minute, intra-vesicular pressure was measured with a saline manometer at full expiration, with the patient lying in the supine position and relaxed abdominal muscles. Zero reference level will be taken at the mid-axillary line level. A conversion factor of 1.36 was used to convert the measured pressure in centimetres into mm Hg. Intra-abdominal pressure will be measured soon after admission, after completion of the operation, and subsequently at an interval of 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours in the postoperative period. The presence of IAH will be categorized into four grades; Grade 1 (lAP 12 - 15 mm Hg), Grade 2 (lAP 16 - 20 mm Hg), Grade 3 (lAP 21- 25 mm Hg) and Grade 4 (lAP > 25 mm Hg) as per WSACS guideline. The acute physiology and chronic health evaluation (APACHE) ll score will be calculated at the time of admission and 72 hours after laparotomy in all the patients. The abdominal wound complications will be identified according to guidelines recommended by the Centre for Disease Control and Prevention (CDC) for diagnosis of surgical site infections. Wound infection or superficial surgical site infection will be considered when the depth of infection will be confined to the skin, and subcutaneous tissue and wound dehiscence are defined as the separation of the abdominal musculoaponeurotic layers. Complete epithelisation in open wounds and the absence of signs of dehiscence after suture removal in sutured wounds will be considered adequate wound healing. The patients will be discharged when their oral feeding will be considered sufficient to meet daily nutritional requirements, the absence of fever for 48 hours, and a healing abdominal wound can be managed at the residence of the patient. Epithelialization is an essential component of wound healing used as a defining parameter of its success. ln the absence of re-epithelialization, a wound cannot be considered healed. 

 
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