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

Xijing Hospital of Digestive Diseases

Status: Unknown

Conditions: Fascial Closure

Treatments: Procedure: modified component separation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03111134

CST001

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Routine Abdominal Closure

No Intervention group

New Abdominal Closure

Experimental group

Description:

modified component separation technique is used to abdomen closing.

Treatment:

Procedure: modified component separation technique