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Clinical trial on the usefulness of surgical guidance and support from a remote location using super vision system technology with 8K images for laparoscopic surgery through ultra-high speed communication such as 5G

Development of endoscopic surgery using 8K Super Hi-Vision technology under remote surgical support by ultra high-speed communication - 8K remote surgical support study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230754
Enrollment
5
Registered
2024-04-26
Start date
2024-04-26
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

colon cancer colon cancer

Interventions

Laparoscopic surgery, which is performed in routine practice, is performed using an endoscopic system with an 8K super-vision system, with surgical support from a remote supervising physician. Treatme
remote surgical assistance

Sponsors

Yukihide Kanemitsu
Lead Sponsor
Japan Agency for Medical Research and Development
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Endoscopic biopsy from the primary colorectal site with histological diagnosis of colorectal cancer (pap, tub1, tub2, por1, por2, sig, or muc). 2) The tumor is predominantly located in either the sigmoid colon (S) or the sigmoid region of the rectum (RS) as comprehensively determined by endoscopy (with enterography if necessary) and CT of the upper abdomen and pelvis. 3) Patient has a diagnosis of cT2-4 based on comprehensive diagnosis using endoscopy and preoperative imaging (enterography or upper abdominal and pelvic CT). 4) Patients must be between 20 and 80 years of age on the date of enrollment. 5) PS (ECOG) is 0 or 1 (PS must be documented in the medical record). 6) All of the following conditions are met. (All laboratory tests must be the most recent within 56 days prior to enrollment. Testing on the same day of the week 8 weeks prior to enrollment is acceptable.) I.White blood cell count >=3,000/mm3 II.Platelet count >=100,000/mm3 III.AST <= 100 U/mm3 IV.AST <= 100 U/L, ALT <= 100U/L V.Total bilirubin <= 2.0 mg/dl VI.Serum creatinine <=1.5 mg/dl

Exclusion criteria

Exclusion criteria: 1) Patients with suspected metastasis to other organs. 2) Patients with impaired cardiopulmonary function who have difficulty insufflating. 3) Patients with impaired cardiopulmonary function and difficulty changing positions during surgery due to joint movement disorder. 4) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. 5) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.

Design outcomes

Primary

MeasureTime frame
Percentage of time for remote surgical assistance

Secondary

MeasureTime frame
Operation time, blood loss, rate of intraoperative complications, rate of open conversion, participant surveys, qualitative evaluation of surgical videos and evaluation of communication failures

Contacts

Public ContactMoritani konosuke

National Cancer Center Hospital

kmoritan@ncc.go.jp+81-3-3542-2511

Outcome results

None listed

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