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

NCT03111134 | Unknown

• 1 other identifier: CST001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fascial Closure

Keywords

abdominal wound closure techniques; layered closure; component separation technique

Outcome Measures

Primary Outcomes (1)

• Class A healing rate of the surgical incision

  Class A healing rate of the surgical incision after operation

  1 month

Secondary Outcomes (9)

• the incidence rate of incisional complications

  1 month

• the time of suture to clear

  1 month

• hospitalization time after operation

  1 year

• the incidence rate of unplanned second operation

  1 month

• the incidence rate of unplanned readmission

  1 month

Study Arms (2)

Routine Abdominal Closure

NO INTERVENTION

New Abdominal Closure

EXPERIMENTAL

modified component separation technique is used to abdomen closing.

Procedure: modified component separation technique

Interventions

modified component separation technique PROCEDURE

a new abdomen closure technique based on component separation technique

New Abdominal Closure

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Study Officials

• Xiaonan Liu, Ph.D

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Xiaonan Liu, Ph.D

CONTACT

86-029-84771533; liuxnxjh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

CN (1)