Clinical trial NCT05351970: Barbed Suture for Emergency Midline Laparotomy Closure
Official title: Barbed Suture vs. Monofilament for Emergency Midline Laparotomy Closure, a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia of Midline of Abdomen
Keywords: incisional hernia
midline laparotomy
urgency laparotomy
barbed suture
monofilament suture
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with emergency laparotomy performed due to digestive surgical disease.

Brief summary: Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction.

The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.

Detailed description: A retrospective cohort study was performed including patients with urgency midline laparotomy during 2018-2019. Group A was represented by patients with slowly absorbable monofilament continuous suture, while Group B included patients with barbed suture closure.

Main variables were hernia rates one month and one year after surgery, diagnosed by physical exploration and/or imaging. Demographic characteristics, risk factors, among other descriptive determinations were registered.

A total of 128 patients were performed an emergency midline laparotomies, and 110 meet all inclusion criteria. There was equality between sex and median age was 65 years old. Significative differences were observed regarding incisional hernia at 30 days, being less frequent when barbed suture was utilized. These differences were not present at the long-term reevaluation (one year).

In conclusion, midline laparotomy closure must be performed within quality standards. The lack of studies regarding emergency laparotomy closure, the European Hernia Society stated that no recommendations can be given on this patients. Barbed suture appears as a promising option for closure in these specific circumstances, but needs further study.

Eligibility criteria: Inclusion Criteria:

* Emergency laparotomy
* Minimum age of 18 years old.
* Digestive surgical disease.
* Minimum survival of one month postoperatively.

Exclusion Criteria:

* Laparoscopic surgical procedure.
* Non-digestive surgical procedure (gynecology, urology...).

Primary outcomes:
measure: Incisional Hernia 1 month
timeFrame: Hernia 1 month
measure: Incisional Hernia 1 year
timeFrame: Hernia 1 year
Secondary outcomes:
measure: Surgical Site Infection
timeFrame: 1 month
measure: Evisceration
timeFrame: 1 month
measure: Medical complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
References:
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