5-year clinical outcome of the ESTOIH trial comparing the short-bite versus large-bite technique for elective midline abdominal closure

Authors: Fortelny RH, Baumann P, Hofmann A, Riedl S, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Köckerling F, Wöste G, Pession U, Albertsmeier M.

Affiliation: Multicenter European group, sponsored by Aesculap AG

Journal: Hernia, Aug 2025

PMID: 40879826

Key takeaways

• Five-year incisional hernia (IH) was 9% with short-bite vs 14% with large-bite; difference not significant (OR 1.60; p=0.155).

• IH increased from 1→3→5 years in both groups, consistently favoring the short-bite arm.

• Both cohorts used a P4HB monofilament (Monomax) suture

  • Short-stitch cohort used 2-0 P4HB

  • Long-stitch cohort used #1 P4HB

• Most 5-year IHs were epigastric; ~36% (15/42) underwent repair.

Background

Incisional hernia is the most common long-term complication after midline laparotomy, with an estimated incidence averaging ~10–20%.

Objective

Compare 5-year IH after elective midline closure using standardized P4HB suture with short-bite vs large-bite techniques.

Methods

• Design/setting/LOE: Prospective, multicenter, parallel, double-blind RCT (Germany/Austria). Level I.

• Enrollment/analysis: 425 randomized (2014–2019). 5-year ITT n=362 (short-bite 175; large-bite 187). PP n=216 (108/108).

• Eligibility (core): Adults ASA I–III; primary midline laparotomy ≥15 cm; protocol later dropped BMI ≥ 30 exclusion and allowed benign pancreatic disease.

• Interventions (how the stitches differed):

  • Large-bite (“long-stitch”): ~10 mm from fascial edge and between bites; #1 P4HB looped

    • Target 4:1 SL:WL (Stitch length to wound length ratio)

  • Short-bite (“small-stitch”): 5–8 mm from edge, ~5 mm apart; 2-0 P4HB single stranded suture

    • Target SL:WL ≥ 5:1

• Blinding: Patients and outcome assessors blinded; surgeons not blinded.

• Primary endpoint: IH at 1, 3, and 5 years (exam plus ultrasound/CT/MRI; EHS criteria).

• Secondary endpoints: 30-day complications (prior reports); EQ-5D-5L at baseline, 30 days, 1, 3, and 5 years.

• Stats/power: Planned n=468 to detect 50% relative IH reduction at 1 year; recruitment stopped after 424 randomized, reducing power for long-term differences.

Results

• Primary outcome (5 years): ITT IH 9.14% (16/175) short-bite vs 13.90% (26/187) large-bite; OR 1.60 (95% CI 0.82–3.10), p=0.155.

• Trajectory: Persistent separation of curves with significant cumulative increase overall from 1→3→5 years (ITT 4.83%→9.02%→16.03%).

• Hernia characteristics: Mostly epigastric (52%); sizes <4 cm in 48%; repairs in 15/42 (36%).

• Quality of life: Early advantages for short-bite (pain/self-care at 30 days–1 year; anxiety at 3 years) but no group differences at 5 years.

Conclusion

In primary laparotomy closures, the short-bite technique kept 5-year IH numerically lower than large-bite, but differences were not statistically significant; absolute IH remained comparatively low in both groups.

Strengths & limitations

• Multicenter, double-blind RCT with imaging-confirmed IH and 5-year follow-up.

• Same suture material across arms isolates stitch geometry.

• Underpowered at 5 years due to early stop/attrition; technique adherence managed via SL:WL targets and training.

Clinical relevance

Reconstructive surgeons should understand this approach to primary laparotomy closure, but recognize that hernia repair outcome may not translate.