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Safety analysis of robotic right-hemicolectomy for right sided colon cancer

ROBOCOLO study

42

The median age and body mass index were 72 years old and 23.2, respectively. All patients had an ECOG PS 0, and 28 patients had some comorbidity. 13 patients had tumors located in the cecum, 20 in the ascending colon, and 6 in the transverse colon, 21 were diagnosed as clinical stage1, 8 as clinical stage2, and 10 as clinical stage3.

The registration pace was faster than initially predicted, and registration was completed earlier than planned. The number of registered patients at each facility was 38 from Yokohama City University Medical Center, 4 from Yokohama City University Hospital. From August 2021 to February 2023, 42 eligible patients were registered from two institutions. Three patients were excluded because of operation postponement(n=1), violation of eligibility criteria(tumor location in splenic flexure(n=1), and misregistration(n=1), consequently, 39 patients were therefore subjected to the FAS analysis.

Postoperative complications occurred in four cased(10.2%), which did not exceed the nine cases specified in the study protocol, so the primary endpoint was met.Of the four cases, one had a Clavien-Dindo Grade of 1, and three had a Grade2 of 2. For grade1 paralytic ileus(n=1, 2.5%), the diet was postponed a few days due to abdominal retention complaints, which quickly recovered without any medication. Regarding the grade2 comlications, the postoperative paralytic ileus(n=2, 5.1%) and pneumonia(n=1, 2.5%) fully recovered after nasal tube insertion and antibiotic medication, respectively.

Postoperative complications occerred in four cases(10.2%), which did not exceed the nine cases specified in the study protocol, so the primary endpoint was met. ICR was performed in 13 patients(33.3%), PC(C,A) in four patients(10.3%), and RHC in 22 patients(56.5%), accompanied be D3 lymph node dissection in all patients. The median total console time and total operation time were 109 and 170 min, respectively. The mean blood loss was 7.8mL, with a maximum of 61mL. IA was performed in 28 patients(71.8%), including IA-Delta anastomosis in 15(38.5%), IA-Overlap in 10(25.6%), and IA-functional end-to-end anastomosis in three(7.7%). No conversion and no intraoperative adverse events, such as vascular injury, organ damage, or retry of bowel reconstruction, were recorded. The median postoperative stay was 5 days.

This study demonstrated the safety and feasibility of robotic surgery for right-sided colon cancer.

July. 19, 2023

July. 19, 2023

https://doi.org/10.1002/ags3.12718

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT1032210196

Ishibe Atsushi

Yokohama City University Hospital

3-9 Fukuura, Kanazawa-ku, Yokohama

aishibe@yokohama-cu.ac.jp

Watanabe Jun

Yokohama City University Medical Center

4-57 Urafune, Minami-ku, Yokohama

+81-45-261-5656

jun0926@yokohama-cu.ac.jp

Complete

July. 14, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients over 20 years old age
2. Histologically, diagnosed with colon cancer
3. Preoperative diagnosis of curative primary resection
4. Main tumor site is cecum (C), ascending colon (A) or right-sided transverse colon (T) and right-hemicolectomy with D2 or higher lymph node dissection is pre-planned
5. Clinical stage I to IIIC (T1-4b, N0-2b, M0: TNM Classification) has been diagnosed
6. Patients who are diagnosed out of the endoscopic resection
7. Patients with tumor maximum diameter of 8 cm or less
8. Patients who do not recognize multiple lesions that require two or more anastomosis places
9. Patients with ECOG Performance Status (PS) score of 0 to 1
10. Patients who have the judgment to fully understand the research content.
11. Patients with written informed consent to participate in this study.

1. Patients with chemotherapy (systemic anti-cancer drug treatment) and a history of radiation therapy, including treatment for other cancer species.
2. Patients who have a history of open surgery
3. Patients who have a history of laparoscopic stomach resection or colectomy
4. Patients with the latest check values within 14 days before registration meet the following
Leukocyte <3000 / mm 3,
Platelet <75,000 / mm 3,
Hemoglobin <7 G / DL,
AST> 100 IU / L,
ALT> 100 IU / L,
Serum Cr> 1.5 mg / dl.
5. Other patients who are judged to be unsuitable as a subject by the doctor's judgment.

Both

Health Condition(s) or Problem(s) Studied Colon cancer

Robotic right-hemicolectomy

Postoperative complications within 30 days after surgery

1. Conversion rate
2. Readmission rate within 30 days after surgery
3. Mortality rate within 30 days after surgery
4. Intraoperative adverse events (vascular damage / organ damage / reconstruction / other)
5. Postoperative recovery (postoperative hospital stay, time to first flatus, time to first oral intake)
6. Surgical results (blood loss, operative time, console time, harvested lymph node number, R0 resection rate)

+81-45-370-7627

July. 05, 2021

none