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

Fascial Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03111134
• Other study ID #: CST001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2017
• Last updated: April 7, 2017
• Start date: May 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2017
• Source: Xijing Hospital of Digestive Diseases
• Contact: Xiaonan Liu, Ph.D
• Phone: 86-029-84771533
• Email: liuxnxjh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fascial Closure

Intervention

Procedure:
• modified component separation technique
a new abdomen closure technique based on component separation technique

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Class A healing rate of the surgical incision	Class A healing rate of the surgical incision after operation	1 month
Secondary	the incidence rate of incisional complications	the incidence rate of any incisional complications after the surgery	1 month
Secondary	the time of suture to clear	the time of suture to clear after the surgery	1 month
Secondary	hospitalization time after operation	hospitalization time after operation	1 year
Secondary	the incidence rate of unplanned second operation	the incidence rate of unplanned second operation after the surgery	1 month
Secondary	the incidence rate of unplanned readmission	the incidence rate of unplanned readmission after the surgery	1 month
Secondary	the incidence rate of acute pain	the incidence rate of acute pain after the surgery	1 month
Secondary	the mortality	the mortality after the surgery with any reason	1 month
Secondary	the incidence rate of incisional hernia	the incidence rate of incisional hernia after the surgery	3 years
Secondary	hospitalization costs	hospitalization costs for the surgery and its complications	3 years