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Validation of inter mitten pneumatic compression in robot-assisted colorectal surgery

Validation of inter mitten pneumatic compression for thromboprophylaxis in robot-assisted colorectal cancer surgery; single-center, prospect, single arm, confirmatory trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042250068
Enrollment
250
Registered
2025-07-28
Start date
2025-08-26
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

Perform thrombosis prevention using intermittent pneumatic compression from during surgery until the patient starts walking postoperatively.

Sponsors

Shiomi Akio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Planned radical robotic-assisted colorectal surgery for clinical stage I-IV colorectal cancer (2) Aged>=40 years of age. (3) Performance status (PS) of 0-1 according to ECOG criteria (4) No severe organ disorder (bone marrow, lung, kidney, etc.) (5) No deep vein thrombosis on lower extremity venous ultrasonography before enrollment (6) Obtained written informed consent

Exclusion criteria

Exclusion criteria: (1) Planning lateral dissection, surgery for multiple cancers, or combined resection of other organs (2) Contraindication to IPC (3) Requires continued anticoagulation therapy for co-morbidities during surgery (4) Highest-risk patients in the Japanese Guidelines for Prevention of Venous Thromboembolism. (5) Pregnant or lactating women (6) Patients with psychosis, psychiatric symptoms, or dementia that would make it difficult for them to participate in the study (7) Other patients deemed unsuitable for safe conduct of the study by the physician in charge or others

Design outcomes

Primary

MeasureTime frame
Incidence of asymptomatic or symptomatic VTE within 7 days after surgery

Secondary

MeasureTime frame
Incidence of symptomatic VTE within 30 days after surgery Incidence of PE within 30 days after surgery Incidence of complications within 30 days after surgery Relation between postoperative step count and asymptomatic VTE Risk factors for asymptomatic or symptomatic VTE Incidence of elevated liver transaminases on postoperative day 7 Incidence of adverse events associated with the use of IPC

Contacts

Public ContactYusuke Yatabe

Shizuoka Cancer Center

y.yatabe@scchr.jp+81-55-989-5222

Outcome results

None listed

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