Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111134
Enrollment
220
Registered
2017-04-12
Start date
2017-05-01
Completion date
2018-12-31
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fascial Closure

Keywords

abdominal wound closure techniques, layered closure, component separation technique

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.

Interventions

PROCEDUREmodified component separation technique

a new abdomen closure technique based on component separation technique

Sponsors

Xijing Hospital of Digestive Diseases
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Class A healing rate of the surgical incision1 monthClass A healing rate of the surgical incision after operation

Secondary

MeasureTime frameDescription
the time of suture to clear1 monththe time of suture to clear after the surgery
hospitalization time after operation1 yearhospitalization time after operation
the incidence rate of unplanned second operation1 monththe incidence rate of unplanned second operation after the surgery
the incidence rate of unplanned readmission1 monththe incidence rate of unplanned readmission after the surgery
the incidence rate of incisional complications1 monththe incidence rate of any incisional complications after the surgery
the mortality1 monththe mortality after the surgery with any reason
the incidence rate of incisional hernia3 yearsthe incidence rate of incisional hernia after the surgery
hospitalization costs3 yearshospitalization costs for the surgery and its complications
the incidence rate of acute pain1 monththe incidence rate of acute pain after the surgery

Countries

China

Contacts

Primary ContactXiaonan Liu, Ph.D
liuxnxjh@163.com86-029-84771533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026