NCT02469142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

4.9 years

First QC Date

January 4, 2015

Last Update Submit

June 8, 2015

Conditions

Incarcerated Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • the recurrence rate after operation

    ten years

Study Arms (2)

ADM tension-free hernia reparation

EXPERIMENTAL

Use ADM to repair incarcerated inguinal hernia by tension-free

Procedure: ADM tension-free hernia reparation

traditional tension hernia reparation

PLACEBO COMPARATOR

Just repair incarcerated inguinal hernia by nothing in tension condition

Interventions

ADM tension-free hernia reparationPROCEDURE

Use ADM as opposed to nothing to repair incarcerated inguinal hernia

ADM tension-free hernia reparation

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Related Publications (1)

  • Saeter AH, Fonnes S, Li S, Rosenberg J, Andresen K. Mesh versus non-mesh for emergency groin hernia repair. Cochrane Database Syst Rev. 2023 Nov 27;11(11):CD015160. doi: 10.1002/14651858.CD015160.pub2.

    PMID: 38009575DERIVED

Study Officials

  • xiaonan liu, MD

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2015

First Posted

June 11, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

CN(1)