Clinical trial NCT03111134: A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
Official title: A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fascial Closure
Keywords: abdominal wound closure techniques
layered closure
component separation technique
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Class A healing rate of the surgical incision
timeFrame: 1 month
Secondary outcomes:
measure: the incidence rate of incisional complications
timeFrame: 1 month
measure: the time of suture to clear
timeFrame: 1 month
measure: hospitalization time after operation
timeFrame: 1 year
measure: the incidence rate of unplanned second operation
timeFrame: 1 month
measure: the incidence rate of unplanned readmission
timeFrame: 1 month
measure: the incidence rate of acute pain
timeFrame: 1 month
measure: the mortality
timeFrame: 1 month
measure: the incidence rate of incisional hernia
timeFrame: 3 years
measure: hospitalization costs
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Xiaonan Liu, Ph.D
role: STUDY_CHAIR
References: