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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03684902
Other study ID # 43
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2017
Est. completion date September 20, 2018

Study information

Verified date September 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date September 20, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
emergency midline exploratory laparotomy
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.

Locations

Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary wound infection redness, hotness, swelling of the wound 4 weeks after surgery
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