Comparative safety study to assess the risk of anastomotic leakage of two-row versus three-row manual circular staplers in colorectal anastomosis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50692
• EU PAS number:
  EUPAS50570
• Study ID:
  50692
• Official title and acronym:
  Comparative safety study to assess the risk of anastomotic leakage of two-row versus three-row manual circular staplers in colorectal anastomosis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The retrospective cohort study is designed to estimate the risk of anastomotic leak among patients who underwent a left-sided colorectal surgery with use of a 2-row manual circular stapler (Ethicon Manual Circular Staplers or Medtronic EEA™ Circular Stapler with DST™ technology) relative to use of a 3-row manual circular stapler (i.e. Medtronic EEA™ Circular Stapler with Tri-Staple™ technology). This study will include two head-to-head comparisons: Ethicon Manual Circular Stapler versus Medtronic EEA™ Circular Stapler with Tri-Staple™ Technology, and Medtronic EEA™ Circular Stapler with DST™ Technology versus Medtronic EEA™ Circular Stapler with Tri-Staple™ Technology. The index procedure will be defined as the initial procedure in which the device of interest was used. The index admission will include the time from admission to discharge. Propensity score weighting (PSW) will be used for confounding adjustment, followed by log-binomial regression for risk estimation. All eligible patients identified from the Premier Healthcare Database between Jan 2019 and Jun 2022 will be included in the analysis.
• Study status:
  Finalised

Research institution and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 12/01/2023

Actual: 12/01/2023

Study start date

Planned: 23/01/2023

Actual: 30/01/2023

Data analysis start date

Planned: 28/02/2023

Actual: 27/02/2023

Date of final study report

Planned: 30/09/2023

Actual: 18/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson

Study protocol

Initial protocol

RWE23-SAF-001 -Manual Circular Staplers_v1_Redacted

Updated protocol

RWE23-SAF-001 -Manual Circular staplers_V2_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable