Comparison of Method for Skin Closure in Colorectal Cancer.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Compared to tissue adhesives and skin stapling devices, tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness. However, there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery.

In colon cancer surgery, it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness. The purpose of this study is to compare clinical outcomes, including wound infection rates and cost-effectiveness, between two different wound closure methods for colorectal cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients

NCT02652702

Colorectal Carcinoma

TERMINATED PHASE2

Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery

NCT07129512

Adenocarcinoma of the Colon

RECRUITING NA

Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients

NCT02564224

Colorectal Cancer Stoma Closure Technic

NO_LONGER_AVAILABLE

REINFORCEMENT ANASTOMOSIS WITH Modified Cyanacrylate IN Patients Undergoing to Oncologic Colorectal Surgery With Colorectal Anastomosis

NCT03380858

Colorectal Cancer

UNKNOWN

Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study

NCT06709170

Colo-rectal Cancer

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary purpose of the study is to compare and analyze the incidence of surgical site infection within 30 days after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.

The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness, pain level, and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients.

Post-operative wound infection rate, cost (material costs of staplers, adhesives, material costs and service fees for disinfecting wounds occurring in the week after surgery), sex, age, BMI (body mass index), ASA (Anesthesiologists category), past history (diabetes, smoking history) , past abdominal surgery history), cancer stage, pre- and post-operative blood test results (WBC, CRP), biopsy results (cancer type), surgery time, pain on the 1st and 3rd days after surgery (VAS), length of stay, postoperative complications , compare the postoperative results of satisfaction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infection Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Skin adhesive bond

a group which skin closure was performed using Leukosan Adhesive skin bond

Group Type EXPERIMENTAL

skin bond

Intervention Type DEVICE

In the skin bond group, fascia closure is performed for incision sites of 10 mm or more, and skin bond is sufficiently applied after subcuticular suture.

For incision sites less than 10 mm, subcuticular closure is performed without closing the fascia, and then skin bond is applied.

skin stapler

a group which skin closure was performed using skin stapler

Group Type ACTIVE_COMPARATOR

skin stapler

Intervention Type DEVICE

In the skin stapler group, fascia closure is performed on incision sites larger than 10 mm, and the skin is closed at 2-3 mm intervals using a stapler.

For incision sites less than 10 mm, skin closure is performed using a skin stapler without closing the fascia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

skin bond

In the skin bond group, fascia closure is performed for incision sites of 10 mm or more, and skin bond is sufficiently applied after subcuticular suture.

For incision sites less than 10 mm, subcuticular closure is performed without closing the fascia, and then skin bond is applied.

Intervention Type DEVICE

skin stapler

In the skin stapler group, fascia closure is performed on incision sites larger than 10 mm, and the skin is closed at 2-3 mm intervals using a stapler.

For incision sites less than 10 mm, skin closure is performed using a skin stapler without closing the fascia.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* underwent elective colorectal surgery
* aged 19 to 80 years
* ASA (American Society of Anesthesiologists) score: 1, 2
* surgical approach such as laparoscopic or Robotic Xi platform