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Impact of a digital surgical workflow including Digital Device Briefing Tool on morbidity and mortality in a patient population undergoing primary stapled colorectal anastomosis for benign or malignant colorectal disease: protocol for a multicentre prospective cohort study

BMJ open, 2023-03, Vol.13 (3), p.e070053-e070053 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2023 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2022-070053 ;PMID: 36972968

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  • Title:
    Impact of a digital surgical workflow including Digital Device Briefing Tool on morbidity and mortality in a patient population undergoing primary stapled colorectal anastomosis for benign or malignant colorectal disease: protocol for a multicentre prospective cohort study
  • Author: Lauscher, Johannes ; Beyer, Katharina ; Hellinger, Achim ; Croner, Roland S ; Ridwelski, Karsten ; Krautz, Christian ; Lim, Christine ; Coplan, Paul M ; Kurepkat, Marc ; Ribaric, Goran
  • Subjects: Anastomosis, Surgical - methods ; Clinical medicine ; Cohort analysis ; Colectomy - adverse effects ; Colonic Diseases - etiology ; Colorectal cancer ; Colorectal Neoplasms - etiology ; Colorectal Neoplasms - surgery ; Colorectal surgery ; Health & safety ; Hospitals ; Humans ; Infections ; Medical equipment ; Morbidity ; Mortality ; Multicenter Studies as Topic ; Patient safety ; Prospective Studies ; Protocols & guidelines ; Recovery (Medical) ; Surgery ; Surgical anastomosis ; Surgical outcomes ; Surgical techniques ; Teams ; Teamwork ; Workflow
  • Is Part Of: BMJ open, 2023-03, Vol.13 (3), p.e070053-e070053
  • Description: IntroductionWith growing emphasis on surgical safety, it appears fundamental to assess the safety of colorectal resection involving primary stapled anastomosis. Surgical stapling devices can considerably foster patient safety in colorectal surgery, but their misuse or malfunction encompass a unique risk of postoperative complications. The Digital Device Briefing Tool (DDBT) is a digital cognitive aid developed to enhance safe use of the Ethicon circular stapling device during colorectal resection. The purpose of this study is to evaluate how a digital operative workflow, including DDBT, compared with routine surgical care, affects morbidity and mortality in patients undergoing left-sided colorectal resection with primary stapled colorectal anastomosis for colorectal cancer or benign disease.Methods and analysisA multicentre, prospective cohort study will be conducted at five certified academic colorectal centres in Germany. It compares a non-digital with a Johnson & Johnson digital solution (Surgical Process Institute Deutschland (SPI))-guided operative workflow in patients undergoing left hemicolectomy, sigmoidectomy, anterior rectal resection and Hartmann reversal procedure. The sample size is set at 528 cases in total, divided into 3 groups (a non-digital and two SPI-guided workflow cohorts, with and without DDBT) in a ratio of 1:1:1, with 176 patients each. The primary endpoint is a composite outcome comprising the overall rate of surgical complications, including death, during hospitalisation and within the first 30 days after colorectal resection. Secondary endpoints include operating time, length of hospital stay and 30-day hospital readmission rate.Ethics and disseminationThis study will be performed in line with the Declaration of Helsinki. The ethics committee of the Charité—University Medicine Berlin, Germany, approved the study (No: 22-0277-EA2/060/22). Study Investigators will obtain written informed consent from each patient before a patient may participate in this study. The study results will be submitted to an international peer-reviewed journal.Trial registration numberDRKS00029682.
  • Publisher: England: British Medical Journal Publishing Group
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2022-070053
    PMID: 36972968
  • Source: ProQuest One Psychology
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