Inguinal Hernia, Without Mention of Obstruction or GangreneNCT05247983
Tension-free Repair of Inguinal Hernia With "Undissociate Spermatic Cord"
An observational study of Inguinal Hernia, Without Mention of Obstruction or Gangrene, run by Harbin Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Inguinal Hernia, Without Mention of Obstruction or Gangrene
- What is being tested?
- Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: inguinal hernia patients
Who may be able to join
- Inguinal hernia patients who can tolerate surgery
Who cannot join
- Patients who cannot tolerate surgery
About this study
Official title: 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.
Read the 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.
- Being tested
- Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
- Keywords
- Undissociate Spermatic cord, Inguinal hernia, Hernia exclusion, Hernial sac
- Medical subject headings
- Hernia, Inguinal, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"Procedure or surgery
patient undergoing Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Tension-free repair of inguinal hernia with "Undissociate Spermatic cord" Receives: Procedure: Tension-free repair of inguinal hernia with "Undissociate Spermatic cord" | |
| control group | Tension-free repair of inguinal hernia with traditional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery time
the operation time
Measured: 0-120minutes
Bleeding
Blood loss
Measured: surgery
hospital stay
the hospitalization time
Measured: 1-30days
Does it recur
Does it recur
Measured: 18-63months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Mar 2014
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia, Without Mention of Obstruction or GangreneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Lei, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247983
- Sponsor's protocol ID
- 81902421
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Harbin Medical Uniersity
- ClinicalTrials.gov ID
- NCT05247983
- Acronym / sponsor ID
- 81902421
- Keywords
- Undissociate Spermatic cord, Inguinal hernia, Hernia exclusion, Hernial sac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Procedure: Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"Tension-free repair of inguinal hernia with "Undissociate Spermatic cord" |
| control group | – | –Tension-free repair of inguinal hernia with traditional method |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inguinal hernia patients
Key inclusion criteria (1 listed)
- Inguinal hernia patients who can tolerate surgery
Key exclusion criteria (1 listed)
- Patients who cannot tolerate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tension-free repair of inguinal hernia with "Undissociate Spermatic cord"patient undergoing Tension-free repair of inguinal hernia with "Undissociate Spermatic cord" | Procedure or surgery | experimental group |
Primary outcome
surgery time
Time frame: 0-120minutes
the operation time
Bleeding
Time frame: surgery
Blood loss
hospital stay
Time frame: 1-30days
the hospitalization time
Does it recur
Time frame: 18-63months
Does it recur
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia, Without Mention of Obstruction or Gangrene
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
RecruitingPhase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
Inguinal Hernia Unilateral, Inguinal Hernia Bilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, Without Mention of Obstruction or Gangrene, run by Harbin Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgery time (time frame: 0-120minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.