NCT02599623

Brief Summary

This prospective randomized is designed to evaluate the safety and efficacy of hernia repairs using local anesthesia compared with those using general anesthesia for patients with incarcerated hernia.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

November 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

November 5, 2015

Last Update Submit

June 17, 2016

Conditions

AnesthesiaIncarcerated Inguinal Hernia

Keywords

IncarceratedAnesthesiaHernia

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    1 year

Secondary Outcomes (7)

  • Time in ICU

    1 week

  • Time to eat

    1 week to 1 month

  • Time to ambulation

    1 week to 1 month

  • Total cost

    1 week to 1 month

  • Complication rates

    1 week to 1 month

  • +2 more secondary outcomes

Study Arms (2)

Local anesthesia

EXPERIMENTAL

Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Procedure: Local Anesthesia

General anesthesia

ACTIVE COMPARATOR

Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Procedure: General Anesthesia

Interventions

Local AnesthesiaPROCEDURE

Patients in LA group received the local infiltration technique. A mixture of 2% lidocaine 20ml and 0.9%NS 30ml was used as the local anesthetic. Patients required extra analgesia during the surgery were given 20-40mg parecoxib sodium intravenously. Conversion to GA was performed if LA was intolerant for patient, which was evaluated by both anesthetists and surgeons.

Local anesthesia
General AnesthesiaPROCEDURE

In group GA, anesthesia was induced with propofol 2mg/kg and fentanyl 0.1-0.2mg intravenously. Inhalation anesthesia was given at the same time with a mixture of oxygen and isoflurane 1-2% through an intubation.

General anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Primary inguinal hernia
  • ASA I-II
  • 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
  • spirit disease patients
  • automatically exit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hernia

Interventions

Anesthesia, LocalAnesthesia, General

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • TAO CHEN

    RenJi Hospital

    STUDY CHAIR

Central Study Contacts

TAO CHEN, M.D.

CONTACT

+8613601779874dr_chentao78@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 6, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

CN(1)