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Status unknownNCT03111134Updated Apr 12, 2017

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

An interventional study of modified component separation technique in Fascial Closure, sponsored by Xijing Hospital of Digestive Diseases. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-12.

Sponsored by Xijing Hospital of Digestive Diseases · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fascial Closure

Keywords

  • abdominal wound closure techniques
  • layered closure
  • component separation technique
03

In context

Lead sponsor

Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • No intervention
    Routine Abdominal Closure
  • Experimental
    New Abdominal Closure

    modified component separation technique is used to abdomen closing.

    Procedure: modified component separation technique

Interventions

  • Proceduremodified component separation technique

    a new abdomen closure technique based on component separation technique

06

What researchers measure

Primary outcomes

  1. Class A healing rate of the surgical incision

    Class A healing rate of the surgical incision after operation

    Time frame: 1 month

Secondary outcomes

  1. the incidence rate of incisional complications

    the incidence rate of any incisional complications after the surgery

    Time frame: 1 month

  2. the time of suture to clear

    the time of suture to clear after the surgery

    Time frame: 1 month

  3. hospitalization time after operation

    hospitalization time after operation

    Time frame: 1 year

  4. the incidence rate of unplanned second operation

    the incidence rate of unplanned second operation after the surgery

    Time frame: 1 month

  5. the incidence rate of unplanned readmission

    the incidence rate of unplanned readmission after the surgery

    Time frame: 1 month

  6. the incidence rate of acute pain

    the incidence rate of acute pain after the surgery

    Time frame: 1 month

  7. the mortality

    the mortality after the surgery with any reason

    Time frame: 1 month

  8. the incidence rate of incisional hernia

    the incidence rate of incisional hernia after the surgery

    Time frame: 3 years

  9. hospitalization costs

    hospitalization costs for the surgery and its complications

    Time frame: 3 years

07

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03111134
Lead sponsor
Xijing Hospital of Digestive Diseases
Responsible party
Xiaonan Liu (associate professor, Xijing Hospital of Digestive Diseases) — Principal investigator
First posted
Apr 12, 2017
Start date
May 1, 2017 (estimated)
Primary completion
Oct 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Apr 12, 2017

Study contacts

Xiaonan Liu, Ph.D
Contact
liuxnxjh@163.com
86-029-84771533
Xiaonan Liu, Ph.D
study chair · Xijing Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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