Hernia, InguinalNCT05308251
Comparison of Hernia Sac Ligation Versus Invagination
A study testing Lichtenstein Mesh Hernioplasty in people with Hernia, Inguinal and Postoperative Pain, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Postoperative Pain, Recurrence
- What is being tested?
- Lichtenstein Mesh Hernioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Mar 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral uncomplicated indirect hernia
- elective operations
- spinal anesthesia
Who cannot join
- Bilateral hernias
- recurrent cases
- femoral-scrotal hernias
- those who refused to give consent
- those who were given general anesthesia besides spinal anesthesia
- those who were repaired with a method other than Lichtenstein mesh hernioplasty
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Eğitim ve Araştırma Hastanesi
Samsun, 55090
About this study
Official title: Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?
Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.
- Conditions
- Hernia, Inguinal, Postoperative Pain, Recurrence
- Being tested
- Lichtenstein Mesh Hernioplasty
- Keywords
- indirect hernia sac, ligation, invagination
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Recurrence, Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein Mesh HernioplastyProcedure or surgery
The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.
| Study group | Role | What they receive |
|---|---|---|
| high ligation | Active comparator | High ligation of the indirect hernia sac is traditional in inguinal hernia repairs. In this arm, patients with indirect inguinal hernia undergoing open mesh herniorrhaphy will have their hernia sac was opened and high ligated. Receives: Procedure: Lichtenstein Mesh Hernioplasty |
| non-ligation | Experimental | In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen. Receives: Procedure: Lichtenstein Mesh Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain levels
10-point Visual Analogue Scale (VAS)
Measured: postoperative period before discharge-1 year after discharge
Secondary outcomes (3)
postoperative complications
hematoma, seroma, wound infection, urinary retention
Measured: postoperative period before discharge (mainly the first 24 hours)
perioperative outcomes
operative time (minutes), hospital stay (days)
Measured: postoperative period before discharge (mainly the first 24 hours)
recurrence
Number of patients with hernia recurrence
Measured: postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Burak Ciftci, Samsun Education and Research Hospital
- Investigators
- Ahmet Burak Ciftci, Principal investigator, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308251
- Sponsor's protocol ID
- SamsunERH2020
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
PubMed 29330835Chen DC, Morrison J. State of the art: open mesh-based inguinal hernia repair. Hernia. 2019 Jun;23(3):485-492. doi: 10.1007/s10029-019-01983-z. Epub 2019 Jun 4.
PubMed 31165300Stylianidis G, Haapamaki MM, Sund M, Nilsson E, Nordin P. Management of the hernial sac in inguinal hernia repair. Br J Surg. 2010 Mar;97(3):415-9. doi: 10.1002/bjs.6890.
PubMed 20104504Delikoukos S, Lavant L, Hlias G, Palogos K, Gikas D. The role of hernia sac ligation in postoperative pain in patients with elective tension-free indirect inguinal hernia repair: a prospective randomized study. Hernia. 2007 Oct;11(5):425-8. doi: 10.1007/s10029-007-0249-9. Epub 2007 Jun 27.
PubMed 17594052Othman I, Hady HA. Hernia sac of indirect inguinal hernia: invagination, excision, or ligation? Hernia. 2014 Apr;18(2):199-204. doi: 10.1007/s10029-013-1081-z. Epub 2013 Apr 2.
PubMed 23546863Ciftci AB, Ocak S. A comparison of hernia sac ligation versus invagination in Lichtenstein tension-free mesh hernioplasty: does the type of hernia play a role in outcomes? Hernia. 2022 Aug;26(4):1153-1159. doi: 10.1007/s10029-022-02637-3. Epub 2022 Jun 20.
PubMed 35725851
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?
- ClinicalTrials.gov ID
- NCT05308251
- Acronym / sponsor ID
- SamsunERH2020
- Conditions
- Hernia, Inguinal, Postoperative Pain, Recurrence
- Keywords
- indirect hernia sac, ligation, invagination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 4 Apr 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.
Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high ligation | Active comparator | Procedure: Lichtenstein Mesh HernioplastyHigh ligation of the indirect hernia sac is traditional in inguinal hernia repairs. In this arm, patients with indirect inguinal hernia undergoing open mesh herniorrhaphy will have their hernia sac was opened and high ligated. |
| non-ligation | Experimental | Procedure: Lichtenstein Mesh HernioplastyIn this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral uncomplicated indirect hernia
- elective operations
- spinal anesthesia
Key exclusion criteria (6 listed)
- Bilateral hernias
- recurrent cases
- femoral-scrotal hernias
- those who refused to give consent
- those who were given general anesthesia besides spinal anesthesia
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 |
|---|---|---|
| Lichtenstein Mesh HernioplastyThe inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment. | Procedure or surgery | high ligation, non-ligation |
Primary outcome
postoperative pain levels
Time frame: postoperative period before discharge-1 year after discharge
10-point Visual Analogue Scale (VAS)
3 secondary outcomes
postoperative complications
Time frame: postoperative period before discharge (mainly the first 24 hours)
perioperative outcomes
Time frame: postoperative period before discharge (mainly the first 24 hours)
recurrence
Time frame: postoperative 1 year
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 4 Apr 2022.
- Results publication: PubMed 29330835HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
- Results publication: PubMed 31165300Chen DC, Morrison J. State of the art: open mesh-based inguinal hernia repair. Hernia. 2019 Jun;23(3):485-492. doi: 10.1007/s10029-019-01983-z. Epub 2019 Jun 4.
- Results publication: PubMed 20104504Stylianidis G, Haapamaki MM, Sund M, Nilsson E, Nordin P. Management of the hernial sac in inguinal hernia repair. Br J Surg. 2010 Mar;97(3):415-9. doi: 10.1002/bjs.6890.
- Results publication: PubMed 17594052Delikoukos S, Lavant L, Hlias G, Palogos K, Gikas D. The role of hernia sac ligation in postoperative pain in patients with elective tension-free indirect inguinal hernia repair: a prospective randomized study. Hernia. 2007 Oct;11(5):425-8. doi: 10.1007/s10029-007-0249-9. Epub 2007 Jun 27.
- Results publication: PubMed 23546863Othman I, Hady HA. Hernia sac of indirect inguinal hernia: invagination, excision, or ligation? Hernia. 2014 Apr;18(2):199-204. doi: 10.1007/s10029-013-1081-z. Epub 2013 Apr 2.
- Derived from this study: PubMed 35725851Ciftci AB, Ocak S. A comparison of hernia sac ligation versus invagination in Lichtenstein tension-free mesh hernioplasty: does the type of hernia play a role in outcomes? Hernia. 2022 Aug;26(4):1153-1159. doi: 10.1007/s10029-022-02637-3. Epub 2022 Jun 20.
- Individual participant dataSharing planned: Undecided
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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.
Ahmet Burak Ciftci principal investigator
Samsun Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein Mesh Hernioplasty in people with Hernia, Inguinal and Postoperative Pain, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
postoperative pain levels (time frame: postoperative period before discharge-1 year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05308251, which also lists 6 linked publications.
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 4 Apr 2022.