This trial is active, not recruiting.

Condition incarcerated inguinal hernia
Treatment adm tension-free hernia reparation
Phase phase 2/phase 3
Sponsor Xijing Hospital of Digestive Diseases
Start date January 2015
End date December 2019
Trial size 100 participants
Trial identifier NCT02469142, ADM001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Use ADM to repair incarcerated inguinal hernia by tension-free
adm tension-free hernia reparation
Use ADM as opposed to nothing to repair incarcerated inguinal hernia
(Placebo Comparator)
Just repair incarcerated inguinal hernia by nothing in tension condition

Primary Outcomes

the recurrence rate after operation
time frame: ten years

Eligibility Criteria

Male or female participants from 16 years up to 85 years old.

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

Additional Information

Official title Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases.