- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05247983
Tension-free Repair of Inguinal Hernia With "Undissociate Spermatic Cord"
February 9, 2022 updated by: Zhao Lei, Harbin Medical University
The First Affiliated Hospital of Harbin Medical Uniersity
The theory of "undissected Spermatic cord (US)" only transected the hernia ring ends in the abdominal cavity, the hernia ring, hernia sac and spermatic cord will not be dissected.
Its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In recent years, with the deepening of the anatomical cognition of the inguinal region and the renewal of the hernia repair concept, inguinal hernia repair has become increasingly mature surgical approach.
However, no matter how the hernia repair modes change, the treatment and repair of the hernia ring has always been the focus, so that the treatment of the hernia sac has been neglected.
From March 2014 to May 2019, there were 132 patients underwent inguinal hernia repair with "Undissociate Spermatic cord" theory (Undissected Spermatic cord and hernia sac, hernia ring and sac exclusion).
All the patients were followed up for 18~63 months (mean of 41.5 months) without recurrence.
Its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.
Study Type
Observational
Enrollment (Actual)
134
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 72 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
inguinal hernia patients
Description
Inclusion Criteria:
- Inguinal hernia patients who can tolerate surgery
Exclusion Criteria:
- Patients who cannot tolerate surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
experimental group
Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
|
patient undergoing Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
|
control group
Tension-free repair of inguinal hernia with traditional method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgery time
Time Frame: 0-120minutes
|
the operation time
|
0-120minutes
|
Bleeding
Time Frame: surgery
|
Blood loss
|
surgery
|
hospital stay
Time Frame: 1-30days
|
the hospitalization time
|
1-30days
|
Does it recur
Time Frame: 18-63months
|
Does it recur
|
18-63months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2014
Primary Completion (ACTUAL)
March 1, 2019
Study Completion (ACTUAL)
March 1, 2019
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
February 9, 2022
First Posted (ACTUAL)
February 21, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 21, 2022
Last Update Submitted That Met QC Criteria
February 9, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81902421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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