Effects of the Short Stitch Technique for Midline Abdominal Closure on Incisional Hernia (ESTOIH): Randomized Clinical Trial

Author:

Fortelny René H12,Andrade Dorian3,Schirren Malte3ORCID,Baumann Petra4,Riedl Stefan5,Reisensohn Claudia5,Kewer Jan Ludolf6,Hoelderle Jessica6,Shamiyeh Andreas7,Klugsberger Bettina7,Maier Theo David8,Schumacher Guido9,Köckerling Ferdinand10ORCID,Pession Ursula11,Hofmann Anna1,Albertsmeier Markus3ORCID

Affiliation:

1. Wilhelminenspital, Allgemein, Viszeral und Tumorchirurgie , Vienna , Austria

2. Sigmund Freud Privat Universität, Med. Fakultät , Vienna , Austria

3. Ludwig-Maximilians-Universität (LMU) Munich, LMU University Hospital, Department of General, Visceral and Transplantation Surgery , Munich , Germany

4. Aesculap AG, Department of Medical Scientific Affairs, Am Aesculap Platz , Tuttlingen , Germany

5. Alb Fils Klinik GmbH, Klinik am Eichert, Allgemeinchirurgie , Göppingen , Germany

6. Klinikum Landkreis Tuttlingen, Klinik für Allgemein, Viszeral und Gefäßchirurgie , Tuttlingen , Germany

7. Kepler Universitätsklinikum GmbH, Klinik für Allgemein und Viszeralchirurgie , Linz , Austria

8. Robert-Bosch-Krankenhaus, Allgemein und Viszeralchirurgie , Stuttgart , Germany

9. Städtisches Klinikum Braunschweig, Chirurgische Klinik , Braunschweig , Germany

10. Vivantes Humboldt-Hospital, Hernia Center , Berlin , Germany

11. Universitätsklinikum Frankfurt, Zentrum der Chirurgie, Klinik für Allgemein und Viszeralchirurgie , Frankfurt am Main , Germany

Abstract

Abstract Background Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. Methods A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. Results The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). Conclusion The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov)

Funder

B.Braun Surgical SA, Rubi, Spain

Medical Scientific Affairs department of Aesculap AG

Publisher

Oxford University Press (OUP)

Subject

Surgery

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