General SurgeryNCT04269330
Normal and Small Size Mesh in Open Inguinal Herni Repair
A study of General Surgery and Inguinal Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Surgery, Inguinal Hernia, Ventral Hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 2 Oct 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages must be upper 18
Who cannot join
- Morbit obesity (BMI>40)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Comparison of Size Mesh and Undersized Mesh in Open Inguinal Hernia Repair: A Prospective, Randomized Study
Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.
Read the detailed description
Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital.
Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used.
Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period.
Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.
Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table.
The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon.
Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file.
Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form.
Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain.
- Conditions
- General Surgery, Inguinal Hernia, Ventral Hernia
- Being tested
- Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
- Keywords
- mesh size, lichtenstein hernia repair, surgical technique
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.Procedure or surgery
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
| Study group | Role | What they receive |
|---|---|---|
| 1-Normal size mesh in open inguinal herni | Sham comparator | Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. Receives: Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. |
| 2- small size mesh in open inguinal herni | Active comparator | Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. Receives: Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of treatment.
The success of normal size mesh with small mesh as a result of hernia treatment
Measured: 1 year
Secondary outcomes (1)
patient satisfaction
As a result of hernia treatment, the patient's satisfaction in normal size mesh with small mesh is achieved.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start20 Feb 2020
- Primary completion20 Sep 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for General SurgeryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
- Investigators
- Alpaslan Şahin, MD, Principal investigator, Konya Training and Research Hospital, Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269330
- Sponsor's protocol ID
- Konya EAH
- Status last verified
- Oct 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.
PubMed 31222460Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.
PubMed 29974028Seker D, Oztuna D, Kulacoglu H, Genc Y, Akcil M. Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size. Hernia. 2013 Apr;17(2):167-75. doi: 10.1007/s10029-012-1018-y. Epub 2012 Nov 11.
PubMed 23142904
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Size Mesh and Undersized Mesh in Open Inguinal Hernia Repair: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT04269330
- Acronym / sponsor ID
- Konya EAH
- Conditions
- General Surgery, Inguinal Hernia, Ventral Hernia
- Keywords
- mesh size, lichtenstein hernia repair, surgical technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 13 Feb 2020 (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.
Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.
Detailed description
Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital.
Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used.
Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period.
Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.
Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table.
The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon.
Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file.
Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form.
Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Normal size mesh in open inguinal herni | Sham comparator | Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. |
| 2- small size mesh in open inguinal herni | Active comparator | Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ages must be upper 18
Key exclusion criteria (1 listed)
- Morbit obesity (BMI>40)
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 |
|---|---|---|
| Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. | Procedure or surgery | 1-Normal size mesh in open inguinal herni, 2- small size mesh in open inguinal herni |
Primary outcome
The success of treatment.
Time frame: 1 year
The success of normal size mesh with small mesh as a result of hernia treatment
1 secondary outcome
patient satisfaction
Time frame: 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 5 Oct 2020.
- Background: PubMed 31222460Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.
- Background: PubMed 29974028Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.
- Background: PubMed 23142904Seker D, Oztuna D, Kulacoglu H, Genc Y, Akcil M. Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size. Hernia. 2013 Apr;17(2):167-75. doi: 10.1007/s10029-012-1018-y. Epub 2012 Nov 11.
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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.
Alpaslan Şahin, MD principal investigator
Konya Training and Research Hospital, Department of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of General Surgery and Inguinal Hernia, run by Konya Meram State 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 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 5 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
The success of treatment. (time frame: 1 year). 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 NCT04269330, which also lists 3 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 5 Oct 2020.