Skip to content

A prospective study of intraoperative head and neck fixation using EIGHT-FIT

Measurement of capability for fixation of the head and neck position during robot-assisted colorectal cancer surgery using EIGHT-FIT, prospective study (MACURA-FIT study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042260071
Enrollment
60
Registered
2026-06-23
Start date
2026-06-23
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Colorectal cancer

Interventions

Intraoperative posture management using the medical device Eight-Fit head and neck support pillow.

Sponsors

Shiomi Akio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Age 18 or older at the time of consent acquisition. 2)Patients are scheduled to undergo robotic-assisted sigmoid colectomy or rectal resection. 3)Patients in which positioning under general anesthesia are deemed safe in preoperative evaluation. 4)Patients who have received sufficient explanation of the study and provided written consent prior to enrollment in the study.

Exclusion criteria

Exclusion criteria: 1)Patients involving the head and neck region with a history of pre-existing conditions, comorbidities, or pre-operative symptoms that make it difficult to evaluate postoperative head and neck-related symptoms. 2)Patients planned to be performed simultaneously multiple organ resection, lateral lymph node dissection, or other surgical procedures. 3)Patients scheduled to undergo splenic flexure mobilization. 4)Patients with hypersensitivity to polyvinyl chloride or polyurethane.

Design outcomes

Primary

MeasureTime frame
Presence or absence of postoperative head and neck related physical symptoms. (pain, numbness, discomfort, etc.)

Secondary

MeasureTime frame
- Head position displacement angle during surgery. - Frequency of head position adjustments by operating room nurses during surgery. - Presence or absence of postoperative head and neck skin disorders. - Presence or absence of postoperative restriction of head and neck range of motion.

Contacts

Public ContactShoichi Manabe

Shizuoka Cancer Center

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026