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Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02469142
Enrollment
100
Registered
2015-06-11
Start date
2015-01-31
Completion date
2019-12-31
Last updated
2015-06-11

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

Conditions

Incarcerated Inguinal Hernia

Brief summary

Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.

Detailed description

observation indicator: 1. recurrence rate after operation 2. incidence rate of complications 3. postoperative hospital stay 4. hospitalization costs 5. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Interventions

PROCEDUREADM tension-free hernia reparation

Use ADM as opposed to nothing to repair incarcerated inguinal hernia

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
16 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of incarcerated hernia * randomly select patch agreed by patients and family members

Exclusion criteria

* severe organ dysfunction * No-tolerate anesthesia * No-suitable for operation * glucocorticoid with long-term use * Sever intraperitoneal adhesion existed * spirit disease patients * automatically exit

Design outcomes

Primary

MeasureTime frame
the recurrence rate after operationten years

Countries

China

Outcome results

None listed

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