Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial
Abstract Aim The aim of this study was to compare the outcomes of GM142, a newly developed gelatin film with a concave and convex structure to a commercially available conventional film, hyaluronate‐carboxymethylcellulose. Methods Patients with primary rectal cancer who were scheduled for diverting...
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| Format: | Article |
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Wiley
2022-07-01
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| Series: | Annals of Gastroenterological Surgery |
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| Online Access: | https://doi.org/10.1002/ags3.12544 |
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| author | Jun Watanabe Shigeki Yamaguchi Ichiro Takemasa Masayoshi Yasui Yasumitsu Hirano Daisuke Nakano Akio Shiomi Shinya Munakata Masanori Naito Shunsuke Tsukamoto Atsushi Ishibe Yoshiaki Kuriu Yasutake Uchima Shinichiro Mori Hideki Kanazawa Go Wakabayashi Takeshi Yamada Muneaki Ezu Masahiko Watanabe Yusuke Kinugasa |
| author_facet | Jun Watanabe Shigeki Yamaguchi Ichiro Takemasa Masayoshi Yasui Yasumitsu Hirano Daisuke Nakano Akio Shiomi Shinya Munakata Masanori Naito Shunsuke Tsukamoto Atsushi Ishibe Yoshiaki Kuriu Yasutake Uchima Shinichiro Mori Hideki Kanazawa Go Wakabayashi Takeshi Yamada Muneaki Ezu Masahiko Watanabe Yusuke Kinugasa |
| author_sort | Jun Watanabe |
| collection | DOAJ |
| description | Abstract Aim The aim of this study was to compare the outcomes of GM142, a newly developed gelatin film with a concave and convex structure to a commercially available conventional film, hyaluronate‐carboxymethylcellulose. Methods Patients with primary rectal cancer who were scheduled for diverting ileostomy during laparoscopic surgery were eligible for this study. Patients were randomized before surgery and an antiadhesion film was applied under the umbilical incision. The primary outcome was the incidence of adhesion under the midline incision confirmed by second‐look surgery for diverting ileostomy closure. The secondary outcomes were the adhesion severity score, the extent of adhesion score, the presence of intestinal obstruction, and the success of all patching. Results A total of 146 patients were enrolled. A total of 123 patients were included in the full analysis set. The primary outcome of “no adhesion” was observed in 66.1% in the GM142 group and 55.7% in the conventional film group. The noninferiority of GM142 to conventional film was confirmed (P = .0005). The secondary outcomes were similar between the groups. For the safety evaluation, there were no safety concerns regarding allergic reactions to gelatin or increased gelatin‐specific IgE antibody titers. Conclusions The noninferiority of GM142 to conventional film was shown. GM142 showed no major safety issues. The clinical safety profiles of GM142 suggested certain physiological benefits of the gelatin film as an adhesion barrier. |
| first_indexed | 2024-04-13T13:42:21Z |
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| institution | Directory Open Access Journal |
| issn | 2475-0328 |
| language | English |
| last_indexed | 2024-04-13T13:42:21Z |
| publishDate | 2022-07-01 |
| publisher | Wiley |
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| series | Annals of Gastroenterological Surgery |
| spelling | doaj.art-5dace512112944e783261651663f22932022-12-22T02:44:35ZengWileyAnnals of Gastroenterological Surgery2475-03282022-07-016451552210.1002/ags3.12544Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trialJun Watanabe0Shigeki Yamaguchi1Ichiro Takemasa2Masayoshi Yasui3Yasumitsu Hirano4Daisuke Nakano5Akio Shiomi6Shinya Munakata7Masanori Naito8Shunsuke Tsukamoto9Atsushi Ishibe10Yoshiaki Kuriu11Yasutake Uchima12Shinichiro Mori13Hideki Kanazawa14Go Wakabayashi15Takeshi Yamada16Muneaki Ezu17Masahiko Watanabe18Yusuke Kinugasa19Department of Surgery Gastroenterological Center Yokohama City University Medical Center Yokohama JapanDepartment of Surgery Division of Colorectal Surgery Tokyo Women's Medical University Tokyo JapanDepartment of Surgery Surgical Oncology and Science Sapporo Medical University School of Medicine Hokkaido JapanDepartment of Gastroenterological Surgery Osaka International Cancer Institute Osaka JapanDepartment of Gastroenterological Surgery Saitama Medical University International Medical Center Saitama JapanDepartment of Surgery Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo JapanDivision of Colon and Rectal Surgery Shizuoka Cancer Center Shizuoka JapanDepartment of Coloproctological Surgery Faculty of Medicine Juntendo University Tokyo JapanDepartment of Surgery Kitasato University Medical Center Saitama JapanDepartment of Colorectal Surgery National Cancer Center Hospital Tokyo JapanDepartment of Gastroenterological Surgery Yokohama City University Graduate School of Medicine Yokohama JapanDepartment of Surgery Kyoto Prefectural University of Medicine Kyoto JapanDepartment of Surgery Fuchu Hospital Osaka JapanDepartment of Digestive Surgery, Breast and Thyroid Surgery Kagoshima University Graduate School of Medical Sciences Kagoshima JapanDepartment of Surgery Sagamihara National Hospital National Hospital Organization Kanagawa JapanDepartment of Surgery Ageo Central General Hospital Saitama JapanDepartment of Gastrointestinal and Hepato‐Biliary‐Pancreatic Surgery Nippon Medical School Tokyo JapanMedical Division Gunze Limited Tokyo JapanDepartment of Surgery Kitasato University Kitasato Institute Hospital Tokyo JapanDepartment of Gastrointestinal Surgery Tokyo Medical and Dental University Tokyo JapanAbstract Aim The aim of this study was to compare the outcomes of GM142, a newly developed gelatin film with a concave and convex structure to a commercially available conventional film, hyaluronate‐carboxymethylcellulose. Methods Patients with primary rectal cancer who were scheduled for diverting ileostomy during laparoscopic surgery were eligible for this study. Patients were randomized before surgery and an antiadhesion film was applied under the umbilical incision. The primary outcome was the incidence of adhesion under the midline incision confirmed by second‐look surgery for diverting ileostomy closure. The secondary outcomes were the adhesion severity score, the extent of adhesion score, the presence of intestinal obstruction, and the success of all patching. Results A total of 146 patients were enrolled. A total of 123 patients were included in the full analysis set. The primary outcome of “no adhesion” was observed in 66.1% in the GM142 group and 55.7% in the conventional film group. The noninferiority of GM142 to conventional film was confirmed (P = .0005). The secondary outcomes were similar between the groups. For the safety evaluation, there were no safety concerns regarding allergic reactions to gelatin or increased gelatin‐specific IgE antibody titers. Conclusions The noninferiority of GM142 to conventional film was shown. GM142 showed no major safety issues. The clinical safety profiles of GM142 suggested certain physiological benefits of the gelatin film as an adhesion barrier.https://doi.org/10.1002/ags3.12544antiadhesion barrierGM142hyaluronate‐carboxymethylcelluloselaparoscopic surgeryrectal cancer |
| spellingShingle | Jun Watanabe Shigeki Yamaguchi Ichiro Takemasa Masayoshi Yasui Yasumitsu Hirano Daisuke Nakano Akio Shiomi Shinya Munakata Masanori Naito Shunsuke Tsukamoto Atsushi Ishibe Yoshiaki Kuriu Yasutake Uchima Shinichiro Mori Hideki Kanazawa Go Wakabayashi Takeshi Yamada Muneaki Ezu Masahiko Watanabe Yusuke Kinugasa Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial Annals of Gastroenterological Surgery antiadhesion barrier GM142 hyaluronate‐carboxymethylcellulose laparoscopic surgery rectal cancer |
| title | Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial |
| title_full | Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial |
| title_fullStr | Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial |
| title_full_unstemmed | Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial |
| title_short | Safety, efficacy, and operability of a newly developed absorbable adhesion barrier (GM142) in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery: Randomized controlled trial |
| title_sort | safety efficacy and operability of a newly developed absorbable adhesion barrier gm142 in patients with primary rectal cancer scheduled for diverting ileostomy during laparoscopic surgery randomized controlled trial |
| topic | antiadhesion barrier GM142 hyaluronate‐carboxymethylcellulose laparoscopic surgery rectal cancer |
| url | https://doi.org/10.1002/ags3.12544 |
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