Trial reportPloS one2025
Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001).
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04643197 (Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
Who cites it
2 citing papers in PubMed.
- Barbed continuous suture reduces the risk of specimen extraction site hernia in high-risk obese patients: a CT-based analysis.Surgical endoscopy · 2026Article
- Efficacy of knotless barbed versus conventional sutures for uterine closure during cesarean section: A prospective comparative study.Bioinformation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo identify the effect of fascial closure using barbed sutures on the incidence of incisional hernia in patients undergoing elective midline laparotomy for gynecological diseases.
methodsIn this multicenter, non-blind randomized controlled trial conducted from February to December 2021, patients with a BMI < 35 kg/m2 and aged >18 years, scheduled for midline laparotomy, were randomly assigned to receive either barbed (experimental) or non-barbed sutures (control) for fascial closure. The primary outcome was the cumulative incidence rate of incisional hernia up to 1-year post-surgery. Secondary outcomes included incisional hernia up to 2-years post-surgery, wound complications, and postoperative pain assessed by Brief Pain Inventory-Korean scores, and Numeric Rating Scale.
resultsOut of 174 patients (experimental, 86; control, 88), 36 were excluded due to dropout or loss to follow-up, leaving 138 patients (experimental, 67; control, 71) included in the analysis. The groups were balanced in terms of cancer surgeries, mean wound length, and mean surgery time. The cumulative incidence rates of incisional hernia up to 1-year (0.0% vs. 1.4%; p > 0.999) and 2-years (0.0% vs. 3.4%, p = 0.496) post-surgery did not differ significantly between the experimental and control groups. Additionally, no significant differences were observed in the incidence of wound dehiscence 4 weeks post-surgery, cumulative incidences of wound dehiscence and wound infection up to 4 weeks post-surgery, or postoperative pain scores between the groups.
conclusionsFascial closure using barbed sutures resulted in no cases of incisional hernia up to 2-years post-surgery, but did not demonstrate a significant reduction in incisional hernia rates compared with the non-barbed suture.
trial registrationClinicalTrials.gov NCT04643197.
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