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

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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
Sponsor:
Information provided by (Responsible Party):
Xiaonan Liu, Xijing Hospital of Digestive Diseases

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.


Condition or disease Intervention/treatment Phase
Fascial Closure Procedure: modified component separation technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Class A healing rate of the surgical incision [ Time Frame: 1 month ]
    Class A healing rate of the surgical incision after operation


Secondary Outcome Measures :
  1. the incidence rate of incisional complications [ Time Frame: 1 month ]
    the incidence rate of any incisional complications after the surgery

  2. the time of suture to clear [ Time Frame: 1 month ]
    the time of suture to clear after the surgery

  3. hospitalization time after operation [ Time Frame: 1 year ]
    hospitalization time after operation

  4. the incidence rate of unplanned second operation [ Time Frame: 1 month ]
    the incidence rate of unplanned second operation after the surgery

  5. the incidence rate of unplanned readmission [ Time Frame: 1 month ]
    the incidence rate of unplanned readmission after the surgery

  6. the incidence rate of acute pain [ Time Frame: 1 month ]
    the incidence rate of acute pain after the surgery

  7. the mortality [ Time Frame: 1 month ]
    the mortality after the surgery with any reason

  8. the incidence rate of incisional hernia [ Time Frame: 3 years ]
    the incidence rate of incisional hernia after the surgery

  9. hospitalization costs [ Time Frame: 3 years ]
    hospitalization costs for the surgery and its complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaonan Liu, Ph.D 86-029-84771533 liuxnxjh@163.com

Locations
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China, Shanxi
Xijing Hospital Not yet recruiting
Xi'an, Shanxi, China, 710032
Contact: Xiaonan Liu, Ph.D    +86 29 84771533    liuxnxjh@163.com   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Study Chair: Xiaonan Liu, Ph.D Xijing Hospital

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Responsible Party: Xiaonan Liu, associate professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03111134     History of Changes
Other Study ID Numbers: CST001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaonan Liu, Xijing Hospital of Digestive Diseases:
abdominal wound closure techniques
layered closure
component separation technique