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FENIX study

Feasibility of a novel tissue oxygen saturation monitoring device during rectal cancer surgery: a pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250163
Enrollment
40
Registered
2026-01-15
Start date
2026-01-23
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

Rectal cancer

Interventions

After transection of the distal bowel, tissue oxygen saturation will be measured at the transected margin, 5 cm and 10 cm proximal to the margin, and 5 cm distal to the margin, prior to proximal bowel

Sponsors

Shiomi Akio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histologically proven to be rectal cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous cell carcinoma, carcinoid tumor, endocrine cell carcinoma). (2) The lower margin of the tumor is within 15 cm of the anal margin. (3) Planned to undergo anterior resection. (4) Age 18 years or older at the time of consent. (5) ECOG performance status (PS) is 0 or 1. (6) Major organ function is preserved. (7) Scheduled surgery within 1 month of obtaining consent. (8) Written consent has been obtained from the patient after sufficient explanation of the study content has been given prior to enrollment in this study.

Exclusion criteria

Exclusion criteria: (1) Simultaneous resection of other organs due to multiple cancers is planned. (2) Two or more anastomoses are planned due to multiple colorectal cancers. (3) The principal investigator or sub-investigator are judged to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The proportion of cases in which tissue oxygen saturation at the proximal transection site exceeded 45%

Secondary

MeasureTime frame
Tissue oxygen saturation at the proximal and distal transection sites Incidence of anastomotic leakage within 30 days after surgery Incidence of postoperative complications within 30 days after surgery

Contacts

Public ContactShunsuke Kasai

Shizuoka Cancer Center

s.kasai@scchr.jp+81-55-989-5222

Outcome results

None listed

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