Ana Sofia Ore1, Erik Askenasy2, Marvin Ryou3, Thomas Baldwin4, Christopher C Thompson3, Evangelos Messaris5. 1. Division of Colorectal Surgery, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA, 02215, USA. 2. Division of Colorectal Surgery, UT Health, Houston, TX, USA. 3. Division of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA. 4. School of Veterinary Medicine, Utah State University, Logan, UT, USA. 5. Division of Colorectal Surgery, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA, 02215, USA. emessari@bidmc.harvard.edu.
Abstract
BACKGROUND: Current standard of care for creation of small bowel anastomoses after a loop ileostomy reversal includes the use of stapler devices and sutures. Compression anastomosis devices have been used for decades, aimed toward improved outcomes with a "staple free" & "suture free" anastomosis. The self-forming magnet (SFM) device is a type of compression anastomosis device used to safely and effectively create an end-to-end small bowel anastomosis without the localized inflammatory response seen with sutures or staples, as no foreign bodies are left behind. METHODS: A Good Laboratory Practice preclinical study using a porcine model to evaluate creating an in vivo anastomosis via magnetic compression between two segments of small bowel (jejunum or ileum) was performed. Magnetic anastomoses were compared to stapled and handsewn anastomoses. Six animals were used for the magnetic anastomosis and eight for the two control groups for a total of 14 subjects. RESULTS: Mean creation times were 17.1 min (SD 6.06) for the SFM group, 10.3 min (SD 6.55, CI 95%) for the stapled anastomosis group, and 28.3 min (SD 2.63, CI 95%) for the suture anastomosis group, with a statistically significant difference among groups (p < 0.0021). All evaluated SFM anastomosis, stapled anastomosis, and handsewn anastomosis underwent a burst test with a pressure of 1.3 PSI. All six magnets used for anastomoses were naturally expelled. The range of days to expel magnets was 10-17 days. Intestinal anastomoses using magnets had considerably less residual scarring and intestinal distortion than anastomoses done with either suture or staples. CONCLUSION: This preclinical study documents the safety and efficacy of creating end-to-end small bowel anastomoses after ileostomy takedown using a magnetic compression device. The result is an anastomosis free of foreign objects with less inflammation, scarring, distortion, and mural thickening than seen in sutured or stapled anastomoses.
BACKGROUND: Current standard of care for creation of small bowel anastomoses after a loop ileostomy reversal includes the use of stapler devices and sutures. Compression anastomosis devices have been used for decades, aimed toward improved outcomes with a "staple free" & "suture free" anastomosis. The self-forming magnet (SFM) device is a type of compression anastomosis device used to safely and effectively create an end-to-end small bowel anastomosis without the localized inflammatory response seen with sutures or staples, as no foreign bodies are left behind. METHODS: A Good Laboratory Practice preclinical study using a porcine model to evaluate creating an in vivo anastomosis via magnetic compression between two segments of small bowel (jejunum or ileum) was performed. Magnetic anastomoses were compared to stapled and handsewn anastomoses. Six animals were used for the magnetic anastomosis and eight for the two control groups for a total of 14 subjects. RESULTS: Mean creation times were 17.1 min (SD 6.06) for the SFM group, 10.3 min (SD 6.55, CI 95%) for the stapled anastomosis group, and 28.3 min (SD 2.63, CI 95%) for the suture anastomosis group, with a statistically significant difference among groups (p < 0.0021). All evaluated SFM anastomosis, stapled anastomosis, and handsewn anastomosis underwent a burst test with a pressure of 1.3 PSI. All six magnets used for anastomoses were naturally expelled. The range of days to expel magnets was 10-17 days. Intestinal anastomoses using magnets had considerably less residual scarring and intestinal distortion than anastomoses done with either suture or staples. CONCLUSION: This preclinical study documents the safety and efficacy of creating end-to-end small bowel anastomoses after ileostomy takedown using a magnetic compression device. The result is an anastomosis free of foreign objects with less inflammation, scarring, distortion, and mural thickening than seen in sutured or stapled anastomoses.
Authors: Claire E Graves; Catherine Co; Ryan S Hsi; Dillon Kwiat; Jill Imamura-Ching; Michael R Harrison; Marshall L Stoller Journal: J Am Coll Surg Date: 2017-08-23 Impact factor: 6.113
Authors: Pui Yee Grace Choy; Ian P Bissett; James G Docherty; Bryan R Parry; Arend Merrie; Anita Fitzgerald Journal: Cochrane Database Syst Rev Date: 2011-09-07