Normal and Small Size Mesh in Open Inguinal Herni Repair
Primary Purpose
General Surgery, Inguinal Hernia, Ventral Hernia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Sponsored by
About this trial
This is an interventional treatment trial for General Surgery focused on measuring mesh size, lichtenstein hernia repair, surgical technique
Eligibility Criteria
Inclusion Criteria:
- ages must be upper 18
Exclusion Criteria:
- Morbit obesity (BMI>40)
Sites / Locations
- Konya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
1-Normal size mesh in open inguinal herni
2- small size mesh in open inguinal herni
Arm Description
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.
Outcomes
Primary Outcome Measures
The success of treatment.
The success of normal size mesh with small mesh as a result of hernia treatment
Secondary Outcome Measures
patient satisfaction
As a result of hernia treatment, the patient's satisfaction in normal size mesh with small mesh is achieved.
Full Information
NCT ID
NCT04269330
First Posted
February 3, 2020
Last Updated
October 2, 2020
Sponsor
Konya Meram State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04269330
Brief Title
Normal and Small Size Mesh in Open Inguinal Herni Repair
Official Title
Comparison of Size Mesh and Undersized Mesh in Open Inguinal Hernia Repair: A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Surgery, Inguinal Hernia, Ventral Hernia
Keywords
mesh size, lichtenstein hernia repair, surgical technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-Normal size mesh in open inguinal herni
Arm Type
Sham Comparator
Arm Description
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Arm Title
2- small size mesh in open inguinal herni
Arm Type
Active Comparator
Arm Description
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Intervention Type
Procedure
Intervention Name(s)
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Intervention Description
Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Primary Outcome Measure Information:
Title
The success of treatment.
Description
The success of normal size mesh with small mesh as a result of hernia treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
As a result of hernia treatment, the patient's satisfaction in normal size mesh with small mesh is achieved.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ages must be upper 18
Exclusion Criteria:
Morbit obesity (BMI>40)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpaslan Şahin, MD
Organizational Affiliation
Konya Training and Research Hospital, Department of General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42090
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
31222460
Citation
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.
Results Reference
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PubMed Identifier
29974028
Citation
Anitha 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.
Results Reference
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PubMed Identifier
23142904
Citation
Seker 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.
Results Reference
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Normal and Small Size Mesh in Open Inguinal Herni Repair
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