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Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk

Primary Purpose

Wound Dehiscence

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
emergency midline exploratory laparotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Wound Dehiscence

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All participants were subjected to emergency midline exploration.
  • All participants at any age
  • both sexes were included

Exclusion Criteria:

  • those who arrested on table or at the immediate postoperative period

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

xpolration

Arm Description

women who underwent emergency midline laprotomy

Outcomes

Primary Outcome Measures

wound infection
redness, hotness, swelling of the wound

Secondary Outcome Measures

Full Information

First Posted
September 24, 2018
Last Updated
September 24, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03684902
Brief Title
Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk
Official Title
Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 5, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study was conducted in 250 patients who underwent midline Laparotomy at Kasr Al-Ainy emergency department, Cairo University from August 2017 until March 2018. Factors such as age ,sex, body mass index, substance abuse, previous laparotomy, malignancy, diabetes mellitus , ascites, albumin, renal functions, bilirubin, hemoglobin, intra-abdominal pathology, suture material, creation of stoma, post-operative chest infection, , post-operative paralytic ileus, leakage and wound infection were observed and analyzed with odds ratio and P value
Detailed Description
General Anaesthesia can be appropriate for patients undergoing abdominal surgery. In common practice with rapid sequence induction with inhalational anesthetics (sevoflourane or isoflourane), opioids (fentanyl 1-2 mic/kg with induction & morphine 0.1 mg/kg) and neuromuscular blockers (succinylcholine 0.5 mg/kg or roucroinium 0.9 mg/kg) are used in general anesthesia for abdominal surgical procedures. Once an adequate level of anesthesia has been reached, the initial incision into the skin may be made. A scalpel is first used to cut into the superficial layers of the skin.with the diathermy The incision is then continued through the subcutaneous fat, the abdominal muscles, and finally, the peritoneum. For all the patients, closure of midline laparotomy wound was en-mass closure done with non-absorbable No. 1 (Polypropylene) or slowly absorbable (PDS) (double loop). sutures in continuous single layer fashion with 1 cm interval. The operative details were recorded with special consideration to the operative diagnosis, presence and types of adhesions, duration of surgery, the need for diversion and stoma formation, the use of intraperitoneal drain and the suture material to close the rectus sheath. During the postoperative period, VAS assessment of postoperative pain at 1 , and 24 hours, time of ambulation, time of oral feeding, hospital stay, and postoperative hemoglobin were recorded.Any postoperative complication especially chest infection, wound infection, postoperative leakage and postoperative paralytic ileus were reported. Follow up of all cases was done weekly after discharge for 4 weeks. Examination of wound included inspection for any redness, edema or presence of discharge like pus or serosanguinous fluid. Special attention was given to maintain asepsis. Broad spectrum intravenous antibiotics The antibiotic therapy for the treatment of intra-abdominal infections greatly varies according to the infection severity. It is, in fact, possible to distinguish the intra-abdominal infections in three different categories. Mild infections should be treated promptly with surgical drainage and a short term therapy with a wide range antibiotic including anaerobes (ampicillin/sulbactam, cefoxitin). Mild-moderate infections which are largely the most frequent in the clinical practice should be also treated with a single drug which include anaerobes in its spectrum. Finally severe infections require a more aggressive therapeutic approach with a combination treatment covering anaerobes (clyndamicin, metronidazole), Gram negative rods (ciprofloxacin, aminoglycosides) and Gram positive cocci (penicillins, cephalosporins) including MRSA (glycopetides) and/or VRE (linezolid). with anaerobic coverage was started for all cases and later changed according to culture and sensitivity report. During follow up duration, the participants were assigned to one of two groups. Group I involved patients developed burst abdomen whether partial (bowel not eviscerated) or complete (bowl not eviscerated) and group II involved those who didn't develop it. Half of Sutures were removed after 10 days , all the sutures removed after 14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Dehiscence

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
xpolration
Arm Type
Experimental
Arm Description
women who underwent emergency midline laprotomy
Intervention Type
Procedure
Intervention Name(s)
emergency midline exploratory laparotomy
Other Intervention Name(s)
midline exploratory laparotomy
Intervention Description
Once an adequate level of anesthesia has been reached, the initial incision into the skin may be made. A scalpel is first used to cut into the superficial layers of the skin.with the diathermy The incision is then continued through the subcutaneous fat, the abdominal muscles, and finally, the peritoneum. (Morris J ;2017) For all the patients, closure of midline laparotomy wound was en-mass closure done with non-absorbable No. 1 (Polypropylene) or slowly absorbable (PDS) (double loop). sutures in continuous single layer fashion with 1 cm interval. (Morris J ;2017) The operative details were recorded with special consideration to the operative diagnosis, presence and types of adhesions, duration of surgery, the need for diversion and stoma formation, the use of intraperitoneal drain and the suture material to close the rectus sheath.
Primary Outcome Measure Information:
Title
wound infection
Description
redness, hotness, swelling of the wound
Time Frame
4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All participants were subjected to emergency midline exploration. All participants at any age both sexes were included Exclusion Criteria: those who arrested on table or at the immediate postoperative period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk

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