Ultrasonic versus conventional clipping hemostasis for laparoscopic colon cancer surgery
Clipless Ultrasonic Energy-based Hemostasis Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery: A Pilot Study
NA · Yonsei University · NCT07129512
This trial tests whether using an ultrasonic scalpel instead of clips for vessel control during laparoscopic colon cancer surgery reduces bleeding and speeds recovery for adult patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07129512 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, randomized study in Seoul compares clipless hemostasis using an ultrasonic energy device to conventional clipping with monopolar energy in elective laparoscopic colectomy for colon adenocarcinoma. Patients are randomized 1:1 in the operating room after anesthesia and followed for 30 days postoperatively with standard surveillance thereafter. Primary outcomes include postoperative bleeding frequency and intraoperative bleeding measures, and secondary outcomes include drain output and length of hospital stay. Enrollment is planned over about 18 months with total study duration near five years.
Who should consider this trial
Good fit: Adults aged 19–80 with histologically confirmed colon adenocarcinoma, ECOG 0–2, ASA I–III, no prior abdominal malignancy surgery, not taking anticoagulants, and eligible for elective laparoscopic colectomy are ideal candidates.
Not a fit: Patients with ASA ≥4, significant coagulation disorders, current anticoagulant use, emergency surgery, pregnancy, or inability to complete follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce intraoperative and postoperative bleeding, lower complication rates, and shorten hospital stays for patients having laparoscopic colon cancer surgery.
How similar studies have performed: Ultrasonic energy devices have demonstrated safety and efficacy in various abdominal and laparoscopic procedures, but prospective randomized data specifically for laparoscopic colorectal cancer resections are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 19 to 80 years of age * Patients with histologically confirmed pathologic adenocarcinoma of the colon * Patients with an ECOG score between 0 and 2 * Patients with a preoperative ASA score of I to III * Patients without a history of surgery for abdominal malignancies * Patients with no history of anticoagulation prior to surgery * Patients who understand the study process and treatment plan and are able to complete the informed consent form themselves Exclusion Criteria: * Patients with an ASA score of 4 or higher * People with blood clotting disorders such as liver cirrhosis, end-stage renal failure, or hematologic disorders * Pregnant women * Mentally ill patients who have difficulty giving informed consent * Preoperative blood hemoglobin (Hb) less than 7 g/dL * Patients taking anticoagulants before or after surgery * Patients who have undergone emergency surgery * Patients who are unable to be followed up on an outpatient basi * No Informed consent
Where this trial is running
Seoul
- Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adenocarcinoma of the Colon