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A Randomized Controlled Trial Comparing Long-term Outcomes of Intracorporeal and Extracorporeal Anastomosis

A Randomized Controlled Trial Comparing Long-term Outcomes of Intracorporeal and Extracorporeal Anastomosis in Stage II/III Colon Cancer - Randomized Trial of Long-term Outcomes: Intracorporeal vs. Extracorporeal Anastomosis in Stage II/III Colon Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032240435
Enrollment
1400
Registered
2024-10-28
Start date
2024-12-18
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 (Stage II/III) Colon cancer

Interventions

After obtaining consent, randomization will be performed by the day before surgery, and one of the following anastomosis methods will be employed during the surgery EA Group (Extracorporeal Anastomosi
D000014776
Colon Cancer,Anastomosis,Peritoneal Recurrence

Sponsors

Kinugasa Yusuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients eligible for this study must meet the following criteria: Pathologically diagnosed with colorectal cancer via endoscopic biopsy. Primary tumor located in the cecum, ascending colon, transverse colon, or descending colon, with planned laparoscopic curative surgery. Preoperative imaging indicates Stage II or III cancer. Age between 20 and 80 years at the time of consent. ECOG performance status of 0 to 2. No bowel obstruction expected to hinder adequate bowel preparation with laxatives. Elective surgery. Double Stapling Technique is not planned. Stoma construction is not planned. No history of bowel resection (with specific gastrectomy types and appendectomy excluded from this definition). No prior chemotherapy or radiation therapy. Written informed consent obtained for study participation.

Exclusion criteria

Exclusion criteria: The patient has the following serious comorbidities: Has an infection requiring systemic treatment. Has a fever of 38.0 or higher at the time of enrollment. Is receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs. Has uncontrolled diabetes. Has uncontrolled hypertension. Has unstable angina (new onset within the last 3 weeks or worsening attacks) or a history of myocardial infarction within the last 6 months. Has uncontrolled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. The patient has a mental illness or psychiatric symptoms that interfere with daily life and is judged to have difficulty participating in the study. The patient is pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. The patient is deemed unsuitable for participation in the study by the principal investigator or a sub-investigator for any other reason.

Design outcomes

Primary

MeasureTime frame
RFS; Relapse-free survival

Secondary

MeasureTime frame
1.Incidence of Peritoneal Recurrence 2.Overall Survival 3.Intraoperative and Early Postoperative Outcomes: Duration of Surgery Amount of Blood Loss Days until Flatus or Bowel Movement Date of Diet Resumption Use of Analgesics Length of Hospital Stay Post-Surgery 4. Incidence of Surgical Complications Rate of Intraoperative Complications (from the start of surgery to the end of surgery (closure) Rate of Early Postoperative Complications (from the end of surgery (closure) to within 30 days post-surgery) Rate of Late Postoperative Complications (from 31 days post-surgery to within 5 years post-surgery) 5. Rehospitalization Rate within 90 Days Post-Surgery

Contacts

Public ContactMarie Hanaoka

Institute of Science Tokyo

hanasrg1@tmd.ac.jp+81-3-5803-5254

Outcome results

None listed

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