NIPH Clinical Trials Search

FENIX study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Rectal cancer
Date of first enrollment	23/01/2026
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	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 transection

Outcome(s)

Primary Outcome	The proportion of cases in which tissue oxygen saturation at the proximal transection site exceeded 45%
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.