Ultrasonic versus conventional clipping hemostasis for laparoscopic colon cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
  Seoul, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.