A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery

A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery - A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029543

Enrollment

300

Registered

2017-10-15

Start date

2017-10-17

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

Colon cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients undergoing laparoscopic rectal cancer resection and anastomosis (regardless of cancer stage); 2)Patients with an ECOG PS of 0 or 1; 3)Patients aged at least 20 years; 4)Patients who have given written consent to participate in the study; and 5)Patients with the distal margin of rectal cancer at 15 cm or less from the anal verge.

Exclusion criteria

Exclusion criteria: 1)Patients with serious ischemic heart disease; 2)Patients with cirrhosis or active hepatitis; 3)Patients with dyspnea requiring oxygen administration; 4)Patients under dialysis due to chronic renal failure; 5)Patients requiring combined resection of any other organ; or 6)Patients ineligible for the study for any other reason, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Incidence of anastomotic leakage.	—

Countries

Japan

Contacts

Public ContactToshihiko Nishidate

Sapporo Medical University Department of Surgery, Surgical Oncology and Science

nisidate@sapmed.ac.jp011-611-2111

Outcome results