A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial

At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.

It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.

Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.

In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.

Study Overview

• Status: Unknown
• Conditions: Fascial Closure
• Intervention / Treatment: Procedure: modified component separation technique

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients >18 years of age
• undergoing gastric cancer surgery
• undergoing abdominal surgery first time
• median upper abdominal incision applied (length of incision > 5cm)
• randomly select abdominal closure technique agreed by patients and family members

Exclusion Criteria:

• women who pregnant
• coagulation disorders
• undergoing immunological therapy
• undergoing chemothearphy within 2 weeks before the surgery
• undergoing Abdominal radiotherapy within 8 weeks before the surgery
• spirit disease patients
• the expecting life span less than 48 hours
• no guarantees to follow-up for 3 years
• patients with poor compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Abdominal Closure
Experimental: New Abdominal Closure; modified component separation technique is used to abdomen closing.	Procedure: modified component separation technique; a new abdomen closure technique based on component separation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Class A healing rate of the surgical incision	Class A healing rate of the surgical incision after operation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence rate of incisional complications	the incidence rate of any incisional complications after the surgery	1 month
the time of suture to clear	the time of suture to clear after the surgery	1 month
hospitalization time after operation	hospitalization time after operation	1 year
the incidence rate of unplanned second operation	the incidence rate of unplanned second operation after the surgery	1 month
the incidence rate of unplanned readmission	the incidence rate of unplanned readmission after the surgery	1 month
the incidence rate of acute pain	the incidence rate of acute pain after the surgery	1 month
the mortality	the mortality after the surgery with any reason	1 month
the incidence rate of incisional hernia	the incidence rate of incisional hernia after the surgery	3 years
hospitalization costs	hospitalization costs for the surgery and its complications	3 years

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: abdominal wound closure techniques; layered closure; component separation technique
• Other Study ID Numbers: CST001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No