Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery

NCT07129512 | Recruiting

• 1 other identifier: 4-2023-1029
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Ultrasonic scalpels offer a safer alternative, approved for various surgeries, but their efficacy in colorectal cancer surgery needs prospective validation. STUDY OBJECTIVE Study compares safety/efficacy of clipless vs. clip-type hemostasis using ultrasonic scalpel in colorectal surgery, focusing on post-op bleeding frequency, intraoperative bleed, drainage, hospital stay. STUDY DESIGN This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study's experimental group undergoes surgery with an ultrasonic scalpel, while the control group receives treatment with a monopolar energy device and clips. Allocation to groups, using a 1:1 ratio, is randomized via a computerized table by a blinded coordinator, immediately post-anesthesia. Principal investigators and administrators remain blinded throughout the study. STUDY POPULATION 1\. Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with colonic adenocarcinoma and are subject to a colectomy procedure. All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site. RISK ANALYSIS The surgical procedure, postoperative care, and follow-up will be the same for the experitmental and control groups in this study. The use of the ultrasonic scalpel alone may prevent complications such as clip-induced intestinal obstruction, infection, bleeding from clip dislodgement, bile leakage, and infection, but there is no additional benefit for other subjects. The risk of bleeding when ligating vessels with an ultrasonic scalpel has been demonstrated to be safe in retrospective studies for vessels 7 mm or less (8-17). Vessels larger than 7 mm are ligated using surgical clips because the safety of ligation with the ultrasound scalpel has not been studied. Based on the reported safety of this method of ligation, the risks do not outweigh the benefits when analyzed in the aggregate. QUALIFICATION OF PARTICIPATING SURGEONS

• Laparoscopic surgery: Surgery for colorectal cancer consists of ligating blood vessels to the lesion, detaching or mobilizing the colon, and resecting and anastomosing the bowel.
• Clipless ultrasound energy-based hemostasis arm: the ultrasound scalpel is used to dissect and ligate the vessel, but clips are used for vessels larger than 7 mm in diameter. If there is significant bleeding during the procedure, surgical clips and hemostatic agents may be used for patient safety at the discretion of the surgeon.
• Control arm: a combination of monopolar cautery and surgical clips will be used for vascular ligation and lymph node dissection.
• Procedure standardization and qualification procedure This study is about laparoscopic surgery for colorectal cancer and all surgeries will be performed by surgeons with at least 100 laparoscopic colorectal cancer surgeries.

Conditions

Adenocarcinoma of the Colon

Outcome Measures

Primary Outcomes (1)

• Frequency of postoperative intra-abdominal bleeding with Clavien-Dindo grade II or higher

  Evaluation of the presence of intra-abdominal bleeding after surgery for Clavien-Dindo grade II or greater is considered positive if any of the following are satisfied within postoperative 30 days 1. Blood transfusion was performed because of suspected intra-abdominal bleeding. 2. A contrast-enhanced abdominal pelvic tomogram performed for suspected intra-abdominal hemorrhage demonstrates contrast leakage or the presence of a hemoperitoneum. 3. Angiographic thromboembolization for intra-abdominal bleeding. 4. Reoperation for intra-abdominal bleeding.

  within 30 postoperative days

Secondary Outcomes (9)

• Intraoperative blood loss (estimated blood loss, ml)

  intraoperative

• intraoperative blood transfusion

  intraoperative

• conversion to laparotomy

  intraoperative

• operative time

  intraoperative

• postoperative plasma hemoglobin maximum decrease (mg/dL)

  5 days

Study Arms (2)

Clipless ultrasonic energy-based hemostasis

EXPERIMENTAL

In this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode.

Procedure: Intracorporeal anastomosis

Conventional clipping hemostasis

ACTIVE COMPARATOR

In this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips.

Procedure: Extracorporeal anastomosis

Interventions

Intracorporeal anastomosis PROCEDURE

In this group, the vessel ligation and dissection is performed using an ultrasonic scalpel with advanced hemostasis mode.

Clipless ultrasonic energy-based hemostasis

Extracorporeal anastomosis PROCEDURE

In this group, the vessel ligation and dissection is performed using a monopolar energy device and surgical clips.

Conventional clipping hemostasis

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study subjects will be randomly assigned to: 1. clipless ultrasonic energy-based hemostasis 2. conventional clipping hemostasis

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 19, 2025
• Study Start: March 4, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 24, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)