EssentiAL study

Not Applicable

• Conditions: Rectal cancer

• Registration Number: JPRN-jRCTs031180039
• Lead Sponsor: Takemasa Ichiro

Brief Summary

Blood flow evaluation by ICG fluorescence method significantly reduced the incidence of anastomotic leak for rectal cancer surgery with AV of 12 cm or less. It also significantly reduced the reoperation rate. Blood flow evaluation by ICG fluorescence method is recommended for rectal cancer surgery with AV of 12 cm or less.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Study Completion: 2021-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 850

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anastomotic leakage rate

Secondary Outcome Measures

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