A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection - A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008302

Enrollment

Registered

2012-06-29

Start date

2012-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Endo GIA Tri-Staple

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years old or older (no upper limit) 2) Patients scheduled for DST anastomosis after laparoscopic left colectomy or rectal resection. 3) No history of abdominal surgery(except appendectomy) 4) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1 5) Healthy organ function 6) Written informed consent is obtained from the patient him/herself

Exclusion criteria

Exclusion criteria: 1) laparoscopic surgery under reduced port surgery 2) Patients having pregnant, nursing or probability of pregnancy 3) Patients receiving continued systemic (oral or intravenous) steroids 4) tients with uncontrolled diabetes mellitus (HbA1c >8.0%) 5) Patients having allergic reaction to nickel-chromium alloy 6) Judged difficulty due to study complications related to a psychiatric disorder or psychological symptoms 7) Judged unsuitable patient for study participation by the investigator for any other reason

Design outcomes

Primary

Measure	Time frame
Number of staples used and the condition on rectal stump	—

Countries

Japan

Contacts

Public ContactKoji Okabayashi

Keio University School of Medicine Department of Surgery

03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026