| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K560||Paralytic ileus, |
|
|
Intervention / Comparator Agent
|
|
|
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.
|