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Wound DehiscenceNCT03684902

Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk

A study testing emergency midline exploratory laparotomy in people with Wound Dehiscence, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Wound Dehiscence
What is being tested?
emergency midline exploratory laparotomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteEgypt
Study dates
5 Aug 2017to 20 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy medical school

    Cairo, 12111

Other trials in Egypt

About this study

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

Read the 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.

Being tested
emergency midline exploratory laparotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • emergency midline exploratory laparotomyProcedure or surgery

    Also called 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.

Study groups in NCT03684902
Study groupRoleWhat they receive
xpolrationExperimentalwomen who underwent emergency midline laprotomy
Receives: Procedure: emergency midline exploratory laparotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. wound infection

    redness, hotness, swelling of the wound

    Measured: 4 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start5 Aug 2017
  3. Primary completion30 Aug 2018
  4. Study completion20 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03684902
Sponsor's protocol ID
43
Status last verified
Sep 2018
First submitted
24 Sep 2018
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing emergency midline exploratory laparotomy in people with Wound Dehiscence, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

wound infection (time frame: 4 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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