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

JRCT ID: jRCTs032230754

Registered date:26/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 26/04/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): 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. Treatment during hospitalization other than surgery is the same as in the clinical pathway. Surgical support is provided via ultrahigh-speed communication (optical or 5G line) from Keihanna Open Nano Innovation Center and Soft Industry Plaza TEQS.

Outcome(s)

• Primary Outcome: Percentage of time for remote surgical assistance
• Secondary Outcome: Operation time, blood loss, rate of intraoperative complications, rate of open conversion, participant surveys, qualitative evaluation of surgical videos and evaluation of communication failures

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yukihide Kanemitsu
• Secondary Sponsor: Japan Agency for Medical Research and Development