A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
|ClinicalTrials.gov Identifier: NCT03111134|
Recruitment Status : Unknown
Verified April 2017 by Xiaonan Liu, Xijing Hospital of Digestive Diseases.
Recruitment status was: Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Fascial Closure||Procedure: modified component separation technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
|No Intervention: Routine Abdominal Closure|
Experimental: New Abdominal Closure
modified component separation technique is used to abdomen closing.
Procedure: modified component separation technique
a new abdomen closure technique based on component separation technique
- Class A healing rate of the surgical incision [ Time Frame: 1 month ]Class A healing rate of the surgical incision after operation
- the incidence rate of incisional complications [ Time Frame: 1 month ]the incidence rate of any incisional complications after the surgery
- the time of suture to clear [ Time Frame: 1 month ]the time of suture to clear after the surgery
- hospitalization time after operation [ Time Frame: 1 year ]hospitalization time after operation
- the incidence rate of unplanned second operation [ Time Frame: 1 month ]the incidence rate of unplanned second operation after the surgery
- the incidence rate of unplanned readmission [ Time Frame: 1 month ]the incidence rate of unplanned readmission after the surgery
- the incidence rate of acute pain [ Time Frame: 1 month ]the incidence rate of acute pain after the surgery
- the mortality [ Time Frame: 1 month ]the mortality after the surgery with any reason
- the incidence rate of incisional hernia [ Time Frame: 3 years ]the incidence rate of incisional hernia after the surgery
- hospitalization costs [ Time Frame: 3 years ]hospitalization costs for the surgery and its complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111134
|Contact: Xiaonan Liu, Ph.Demail@example.com|
|Xijing Hospital||Not yet recruiting|
|Xi'an, Shanxi, China, 710032|
|Contact: Xiaonan Liu, Ph.D +86 29 84771533 firstname.lastname@example.org|
|Study Chair:||Xiaonan Liu, Ph.D||Xijing Hospital|