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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Additional medical condition(s):
  left-sided colorectal surgery

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  12000

Study design details

• Main study objective:
  To estimate the risk and relative risk (RR) of anastomotic leak (AL) among patients who underwent a left-sided colorectal surgery with use of a 2-row manual circular stapler relative to use of a 3-row manual circular stapler.
• Outcomes:
  To estimate the risk and RR of AL within 30 days post-index procedure 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). To estimate the RR of AL among patients who underwent a left-sided colorectal surgery with use of a 2-row manual circular stapler relative to use of a 3-row manual circular stapler, stratified by diverting stoma prior to or on the same day as a left-sided colorectal surgery during the index admission.
• Data analysis plan:
  1) Descriptive analyses will be first performed for demographic, clinical, and procedural characteristics of patients at the time of the index procedure where a study device was used. Cumulative incidences of AL and 95% confidence interval (CIs) will calculated for all device cohorts, and also stratified by key characteristics. 2) In the primary analyses, a propensity score weighting (PSW) method will be used to control for potential confounders, followed by log-binomial regression for risk estimation. 3) In the secondary analyses, all primary analyses will be repeated separately in those with and without a diverting stoma procedure prior to or on the same day as the index procedure (i.e. left-sided colorectal surgery) during the index admission. 4) A sensitivity analysis will be conducted by repeating the primary analysis among patients from hospitals with at least 30 days continuous enrollment in PHD after the patients’ index procedure.

Documents

Study results

IJCD online publication