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Study protocol: a multicenter randomized controlled trial of the multifaceted workload reduction of the anti-adhesion barrier for diverting ileostomy in laparoscopic rectal surgery, YCOG 2005 (ADOBARRIER study)

  • Clinical Study Protocol
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Abstract

Background

There are few randomized controlled trials on the efficacy of spray-type anti-adhesion material during diverting ileostomy in laparoscopic rectal cancer surgery.

Purpose

This study will assess whether or not spraying an anti-adhesion material during diverting ileostomy could reduce the surgeon's multifaceted workload in ileostomy closure.

Methods

Patients with laparoscopic or robotic surgery for rectal cancer scheduled for low anterior resection and diverting ileostomy will be enrolled in the ADOBARRIER study (multicenter, single-blind, randomized controlled trial). The target sample size is set at 120 cases, which will be randomly divided into an anti-adhesion material-using group and a non-using group at a ratio of 1:1. The primary endpoint is the multifaceted workload of the surgeon of ileostomy closure using SURG-TLX between groups with and without usage of the anti-adhesion material during diverting ileostomy construction; the secondly endpoint is the operative time, amount of intraoperative blood loss, degree of adhesions, and extent of intra-abdominal adhesions when the ileostomy is closed.

Conclusions

This RCT will evaluate the efficacy and safety of spray-type anti-adhesion material for diverting ileostomy construction. The results of this study are expected to facilitate decision-making regarding the use of anti-adhesion material.

Trial registration

This trial was registered with the Japan Registry of Clinical Trials (jRCT) in October 2020 as jRCTs032200155.

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Funding

This work was supported and funded by TERUMO Co., Ltd.

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Author notes

  1. Authors contributed equally Hiroki Ohya and Jun Watanabe

Authors and Affiliations

  1. Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan

    Hiroki Ohya, Kazuya Nakagawa, Mayumi Ozawa, Atsushi Ishibe & Itaru Endo

  2. Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan

    Jun Watanabe, Kouki Goto, Yusuke Suwa, Sumito Sato, Nobuhiro Sugano & Chikara Kunisaki

  3. Department of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan

    Hirokazu Suwa

Authors
  1. Hiroki Ohya
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  2. Jun Watanabe
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  3. Kouki Goto
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  4. Yusuke Suwa
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  5. Kazuya Nakagawa
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  6. Mayumi Ozawa
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  7. Sumito Sato
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  8. Nobuhiro Sugano
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  9. Hirokazu Suwa
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  10. Atsushi Ishibe
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  11. Chikara Kunisaki
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  12. Itaru Endo
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Corresponding author

Correspondence to Jun Watanabe.

Ethics declarations

Ethics approval (include appropriate approvals or waivers)

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Yokohama City University Certified Review Board (No. CRB3180007).

Conflicts of interest/Competing interests (include appropriate disclosures)

All authors declare no conflicts of interest in association with the present study.

Consent to participate (include appropriate statements)

Informed consent was obtained from all individual participants included in the study.

Consent for publication (include appropriate statements)

Not applicable.

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Ohya, H., Watanabe, J., Goto, K. et al. Study protocol: a multicenter randomized controlled trial of the multifaceted workload reduction of the anti-adhesion barrier for diverting ileostomy in laparoscopic rectal surgery, YCOG 2005 (ADOBARRIER study). Int J Colorectal Dis 36, 2763–2768 (2021). https://doi.org/10.1007/s00384-021-04032-3

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  • DOI: https://doi.org/10.1007/s00384-021-04032-3

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