René H Fortelny1,2, Dorian Andrade3, Malte Schirren3, Petra Baumann4, Stefan Riedl5, Claudia Reisensohn5, Jan Ludolf Kewer6, Jessica Hoelderle6, Andreas Shamiyeh7, Bettina Klugsberger7, Theo David Maier8, Guido Schumacher9, Ferdinand Köckerling10, Ursula Pession11, Anna Hofmann1, Markus Albertsmeier3. 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
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).
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).
Authors: A Aiolfi; M Cavalli; F Gambero; E Mini; F Lombardo; L Gordini; G Bonitta; P G Bruni; D Bona; G Campanelli Journal: Hernia Date: 2022-08-03 Impact factor: 2.920