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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fascial Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine Abdominal Closure

Group Type NO_INTERVENTION

No interventions assigned to this group

New Abdominal Closure

modified component separation technique is used to abdomen closing.

Group Type EXPERIMENTAL

modified component separation technique

Intervention Type PROCEDURE

a new abdomen closure technique based on component separation technique

Interventions

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modified component separation technique

a new abdomen closure technique based on component separation technique

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No