Normal and Small Size Mesh in Open Inguinal Herni Repair
-
- STATUS
- Recruiting
-
- participants needed
- 200
-
- sponsor
- Konya Training and Research Hospital
Summary
Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.
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.
Details
Condition | INGUINAL HERNIA, Ventral Hernia, Surgery |
---|---|
Age | 18-80 years |
Treatment | Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial. |
Clinical Study Identifier | NCT04269330 |
Sponsor | Konya Training and Research Hospital |
Last Modified on | 19 February 2024 |
Similar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.