Actively Recruiting
Clipless Ultrasonic Energy-based Hemostasis Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery: A Pilot Study
Led by Yonsei University · Updated on 2025-08-19
304
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer rates are increasing, and surgery often involves removing affected tissue and tying off blood vessels. Traditional methods use clips to stop bleeding, but these can cause complications like bleeding and infections. This research evaluates whether using an ultrasonic scalpel without clips is safer and more effective during laparoscopic colorectal cancer surgery compared to conventional clipping methods. Participants will be randomly assigned to one of two groups. One group will have surgery using an ultrasonic scalpel for vessel sealing and cutting, while clips will be used only for vessels larger than 7 mm or if bleeding occurs. The other group will receive standard surgery using a monopolar energy device combined with surgical clips. The study is conducted at a single center with experienced surgeons and includes short-term follow-up at 30 days after surgery. Participants will undergo assessments before, during, and after surgery, including monitoring blood loss, bleeding complications, drainage output, and recovery times. Data will be collected at baseline, post-operation, discharge, and one month later. Researchers will track the frequency of postoperative bleeding and other complications. Participants can withdraw at any time without penalty. The total study duration is about five years with enrollment over 18 months.
CONDITIONS
Brief Title
Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 to 80 years of age
- Histologically confirmed adenocarcinoma of the colon
- ECOG performance status between 0 and 2
- Preoperative ASA score of I to III
- No history of surgery for abdominal malignancies
- No prior anticoagulation therapy before surgery
- Able to understand the study and complete informed consent independently
You will not qualify if you...
- ASA score of 4 or higher
- Blood clotting disorders such as liver cirrhosis, end-stage renal failure, or hematologic diseases
- Pregnant women
- Mentally ill patients unable to give informed consent
- Preoperative hemoglobin less than 7 g/dL
- Use of anticoagulants before or after surgery
- Patients undergoing emergency surgery
- Inability to comply with outpatient follow-up
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus hospital stay until discharge
Participants undergo laparoscopic colorectal surgery using either ultrasonic scalpel or conventional clipping for vessel ligation and dissection. Randomization occurs immediately after anesthesia on the day of surgery.
Data collected post-operative and at discharge
Duration - 30 days
Participants are followed for 30 days after surgery to monitor for complications and recovery according to standard guidelines after colorectal cancer surgery.
Visits including 1 follow-up visit at 30 days post-surgery
Duration - Up to 5 years total study duration
Participants are observed according to standard follow-up guidelines after colorectal cancer surgery to monitor their health over time.
Follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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