The Prospective Observational Study investigating the factor impacted on Safety of Endoscopic Right colectomy for colon cancer in Japan

JRCT ID: jRCT1010240021

Registered date:03/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colon cancer
• Date of first enrollment: 03/07/2024
• Target sample size: 2000
• Study type: Observational

Outcome(s)

Primary Outcome

The primary endpoint is the incidence of postoperative complications (Clavien-Dindo Grade III or higher). The rate of severe postoperative complications in all eligible patients will be investigated and risk factors affecting the rate of severe postoperative complications will be extracted.
The key secondary endpoint is the incidence of intraoperative vascular injury around the surgical trunk. The rate of intraoperative vascular injury around the surgical trunk in all eligible patients will be investigated and risk factors affecting the rate of intraoperative vascular injury around the surgical trunk will be extracted.

Secondary Outcome

Secondary endpoints
Other short-term outcomes (operative time, blood loss, conversion rate, degree of dissection, intraoperative complications rate, reoperation rate, R0 resection rate), and long-term outcomes (5-year overall survival, recurrence-free survival, and local recurrence rate by stage, the incidence of bowel obstruction and herniated abdominal wall scar). Factors influencing the above will be extracted in all eligible cases. In addition, comparisons will be made for each of the subgroups described below.
1, Comparison of short-term results by approach
a. Medial approach vs. retroperitoneal approach
b. Medial approach vs. cranial approach
c. Retroperitoneal approach vs. cranial approach
(a-c. for laparoscopic surgery, a. for robotic surgery)
2, Comparison of short-term results between robot-assisted and laparoscopic surgery (Comparison in all approaches, medial approach, retroperitoneal approach, and in each ASA-PS, respectively)
3, Comparison of short-term results by degree of lymph node dissection (D2,D3v,D3a)
4, Long-term results by approach, robot or laparoscopy, and degree of dissection
5, impact of experience on short-term and long-term outcomes after the surgery performed by the surgeons prior to obtaining board certification in gastrointestinal surgery (including the investigation by each approach, robot/laparoscopy, and degree of lymph node dissection)
6, Impact of number of experienced cases and board certification in gastrointestinal surgery on short-term and long-term outcomes after robot-assisted surgery.
7, The influence of the participation of Endoscopic Surgical Skill Qualification-certified surgeons in surgery and their role in the procedure on short-term and long-term outcomes
8, Influence of anastomosis method on short-term and long-term outcomes
9, Relationship between the presence or absence of drain insertion and the incidence and severity of complications
10, Risk factors for intestinal obstruction (long-term and short-term)
11, Risk factors for complications and severity of complications in the elderly

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include criteria

1, Cases with a diagnosis of adenocarcinoma
2, Cases in which laparoscopic ileocecal resection, laparoscopic right hemicolectomy, or laparoscopic extended right hemicolectomy with D2 or D3 dissection are planned for clinical stage 0, I, II, or III colon located at cecum, ascending or transverse cancer
3, In case with Robotic-assisted surgery, cases after at least 10 cases of ileocecal resection, right hemicolectomy, or extended right hemicolectomy for right-sided colon cancer in the institution are included.

Exclude criteria

1, Multiple colorectal cancers and multiple primary cancers
(Concurrent multiple cancers or multiple cancers with a disease-free period of 5 years or less from the time of registration. However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in multiple cancers.)
2, Ulcerative colitis-related cancer
3, Cases who have requested to withdraw from participation in this study.
4, Cases deemed inappropriate by the investigator

Related Information

• Primary Sponsor: Yamaguchi Shigeki
• Secondary Sponsor: Ichikawa Nobuki
• Source(s) of Monetary Support: Japan Society of Laparoscopic Colorectal Surgery