EssentiAL study

JRCT ID: jRCTs031180039

Registered date:19/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 17/12/2018
• Target sample size: 850
• Study type: Interventional
• Intervention(s): Evaluation of blood flow by near infrared imaging

Outcome(s)

• Primary Outcome: Anastomotic leakage rate

Secondary Outcome

Anastomotic leakage rate(Grade B+C)
Fluorescence time at the oral side anastomotic site
Rate of the additional transection of the proximal colon toward the oral side
Length of the additional transection of the proximal colon toward the oral side
Rates of complications within 30 days after surgery
Rates of complications during surgery
Reoperation rate
Postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients who are histologically proven to be rectal cancer
2.The lower edge of the tumor is within 12 cm from the anal verge
3.Patients diagnosed with Stage 0-3 in preoperative diagnostic imaging
4.Patients who are scheduled for rectal resection with intestinal anastomosis (including ISR)
5.Patients with General State Performance Status (ECOG) 0 to 2
6.Patients whose age at registration is 20 years or older
7.Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination
8.About participation in this study Patients who have obtained consent from a document stating signature and date by the applicant

Exclude criteria

1. Patients who are allergic to iodine or indocyanine green
2. Preoperative intestinal obstruction patients
3. Patients planning simultaneous resection of other organs due to double cancer
4. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer
5. Patients with intraperitoneal infection (peritonitis or abdominal abscess)
6. Patients with serious complications (heart disease, lung disease, bleeding tendency, poorly controlled hypertension, diabetes etc.)
7. Concerning females, pregnancy and patients with fear thereof
8. Other patients judged inappropriate by the examining physician

Related Information

• Primary Sponsor: Takemasa Ichiro
• Source(s) of Monetary Support: Stryker Japan K.K.