Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery

results of a multicenter, randomized, prospective, phase II clinical trial

Yoshihiko Maehara, Ken Shirabe, Shunji Kohnoe, Yasunori Emi, Eiji Oki, Yoshihiro Kakeji, Hideo Baba, Masataka Ikeda, Michiya Kobayashi, Tadatoshi Takayama, Shoji Natsugoe, Masashi Haraguchi, Kazuhiro Yoshida, Masanori Terashima, Mitsuru Sasako, Hiroki Yamaue, Norihiro Kokudo, Katsuhiko Uesaka, Shinji Uemoto, Tomoo Kosuge & 9 others Yoshiki Sawa, Mitsuo Shimada, Yuichiro Doki, Masakazu Yamamoto, Akinobu Taketomi, Masahiro Takeuchi, Kouhei Akazawa, Takeharu Yamanaka, Mototsugu Shimokawa

Research output: Contribution to journalReview article

4 Citations (Scopus)

Abstract

Background: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. Methods: At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. Results: The incidence of SSI was 11.3%, 15.5%, 11.3%, and 36.9% after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. Conclusion: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.

Original languageEnglish
Pages (from-to)1060-1071
Number of pages12
JournalSurgery today
Volume47
Issue number9
DOIs
Publication statusPublished - Sep 1 2017

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Surgical Wound Infection
Phase II Clinical Trials
Sutures
Incidence
Silk
Hepatectomy
Colorectal Surgery
Pancreaticoduodenectomy
Gastrectomy
Length of Stay
Pancreatic Fistula
Bile

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery : results of a multicenter, randomized, prospective, phase II clinical trial. / Maehara, Yoshihiko; Shirabe, Ken; Kohnoe, Shunji; Emi, Yasunori; Oki, Eiji; Kakeji, Yoshihiro; Baba, Hideo; Ikeda, Masataka; Kobayashi, Michiya; Takayama, Tadatoshi; Natsugoe, Shoji; Haraguchi, Masashi; Yoshida, Kazuhiro; Terashima, Masanori; Sasako, Mitsuru; Yamaue, Hiroki; Kokudo, Norihiro; Uesaka, Katsuhiko; Uemoto, Shinji; Kosuge, Tomoo; Sawa, Yoshiki; Shimada, Mitsuo; Doki, Yuichiro; Yamamoto, Masakazu; Taketomi, Akinobu; Takeuchi, Masahiro; Akazawa, Kouhei; Yamanaka, Takeharu; Shimokawa, Mototsugu.

In: Surgery today, Vol. 47, No. 9, 01.09.2017, p. 1060-1071.

Research output: Contribution to journalReview article

Maehara, Y, Shirabe, K, Kohnoe, S, Emi, Y, Oki, E, Kakeji, Y, Baba, H, Ikeda, M, Kobayashi, M, Takayama, T, Natsugoe, S, Haraguchi, M, Yoshida, K, Terashima, M, Sasako, M, Yamaue, H, Kokudo, N, Uesaka, K, Uemoto, S, Kosuge, T, Sawa, Y, Shimada, M, Doki, Y, Yamamoto, M, Taketomi, A, Takeuchi, M, Akazawa, K, Yamanaka, T & Shimokawa, M 2017, 'Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial', Surgery today, vol. 47, no. 9, pp. 1060-1071. https://doi.org/10.1007/s00595-017-1480-3
Maehara, Yoshihiko ; Shirabe, Ken ; Kohnoe, Shunji ; Emi, Yasunori ; Oki, Eiji ; Kakeji, Yoshihiro ; Baba, Hideo ; Ikeda, Masataka ; Kobayashi, Michiya ; Takayama, Tadatoshi ; Natsugoe, Shoji ; Haraguchi, Masashi ; Yoshida, Kazuhiro ; Terashima, Masanori ; Sasako, Mitsuru ; Yamaue, Hiroki ; Kokudo, Norihiro ; Uesaka, Katsuhiko ; Uemoto, Shinji ; Kosuge, Tomoo ; Sawa, Yoshiki ; Shimada, Mitsuo ; Doki, Yuichiro ; Yamamoto, Masakazu ; Taketomi, Akinobu ; Takeuchi, Masahiro ; Akazawa, Kouhei ; Yamanaka, Takeharu ; Shimokawa, Mototsugu. / Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery : results of a multicenter, randomized, prospective, phase II clinical trial. In: Surgery today. 2017 ; Vol. 47, No. 9. pp. 1060-1071.
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title = "Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery: results of a multicenter, randomized, prospective, phase II clinical trial",
abstract = "Background: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. Methods: At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. Results: The incidence of SSI was 11.3{\%}, 15.5{\%}, 11.3{\%}, and 36.9{\%} after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. Conclusion: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.",
author = "Yoshihiko Maehara and Ken Shirabe and Shunji Kohnoe and Yasunori Emi and Eiji Oki and Yoshihiro Kakeji and Hideo Baba and Masataka Ikeda and Michiya Kobayashi and Tadatoshi Takayama and Shoji Natsugoe and Masashi Haraguchi and Kazuhiro Yoshida and Masanori Terashima and Mitsuru Sasako and Hiroki Yamaue and Norihiro Kokudo and Katsuhiko Uesaka and Shinji Uemoto and Tomoo Kosuge and Yoshiki Sawa and Mitsuo Shimada and Yuichiro Doki and Masakazu Yamamoto and Akinobu Taketomi and Masahiro Takeuchi and Kouhei Akazawa and Takeharu Yamanaka and Mototsugu Shimokawa",
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TY - JOUR

T1 - Impact of intra-abdominal absorbable sutures on surgical site infection in gastrointestinal and hepato-biliary-pancreatic surgery

T2 - results of a multicenter, randomized, prospective, phase II clinical trial

AU - Maehara, Yoshihiko

AU - Shirabe, Ken

AU - Kohnoe, Shunji

AU - Emi, Yasunori

AU - Oki, Eiji

AU - Kakeji, Yoshihiro

AU - Baba, Hideo

AU - Ikeda, Masataka

AU - Kobayashi, Michiya

AU - Takayama, Tadatoshi

AU - Natsugoe, Shoji

AU - Haraguchi, Masashi

AU - Yoshida, Kazuhiro

AU - Terashima, Masanori

AU - Sasako, Mitsuru

AU - Yamaue, Hiroki

AU - Kokudo, Norihiro

AU - Uesaka, Katsuhiko

AU - Uemoto, Shinji

AU - Kosuge, Tomoo

AU - Sawa, Yoshiki

AU - Shimada, Mitsuo

AU - Doki, Yuichiro

AU - Yamamoto, Masakazu

AU - Taketomi, Akinobu

AU - Takeuchi, Masahiro

AU - Akazawa, Kouhei

AU - Yamanaka, Takeharu

AU - Shimokawa, Mototsugu

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Background: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. Methods: At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. Results: The incidence of SSI was 11.3%, 15.5%, 11.3%, and 36.9% after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. Conclusion: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.

AB - Background: The use of absorbable sutures in wound closure has been shown to reduce the incidence of surgical site infection (SSI); however, there is no evidence that the intra-abdominal use of absorbable rather than silk sutures reduces the incidence of SSI after gastrointestinal surgery. We report the findings of a phase II trial, designed to evaluate the impact of the intra-abdominal use of absorbable sutures on the incidence of SSI. Methods: At 19 Japanese hospitals, 1147 patients undergoing elective gastrectomy, colorectal surgery, hepatectomy, or pancreaticoduodenectomy (PD) were randomly assigned to absorbable or silk intra-abdominal suture groups. The primary efficacy endpoint was the incidence of SSI. The secondary efficacy endpoints were the locations of SSI, time to resolution of SSI, length of hospital stay, and the incidence of bile leakage in hepatectomy and pancreatic fistula. Results: The incidence of SSI was 11.3%, 15.5%, 11.3%, and 36.9% after gastrectomy, colorectal surgery, hepatectomy, and PD, respectively. The incidence of SSI was higher in the absorbable suture group than in the silk suture group for all the surgical procedures, but the difference was not significant. Conclusion: The intra-abdominal use of absorbable sutures did not have enough of an effect on the reduction of SSI in this phase II trial to justify the planning of a large-scale phase III trial.

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U2 - 10.1007/s00595-017-1480-3

DO - 10.1007/s00595-017-1480-3

M3 - Review article

VL - 47

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EP - 1071

JO - Surgery Today

JF - Surgery Today

SN - 0941-1291

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