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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06417346
Other study ID # 65646564
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 4, 2023
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source Konya City Hospital
Contact Abdullah Hilmi Yilmaz, MD
Phone 0432 222 00 10
Email drabdullahhilmi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 30, 2024
Est. primary completion date June 4, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients with inguinal hernias. - Patients aged over 65. Exclusion Criteria: - Younger than 65 years. - Incarcerated or strangulated inguinal hernias.

Study Design


Intervention

Procedure:
Laparoscopic TEP Repair
Laparoscopic TEP Repair performed
Open Technique (Lichtenstein)
Open Technique (Lichtenstein) performed

Locations

Country Name City State
Turkey University of Health Science Van Training and Research Hospital Van

Sponsors (2)

Lead Sponsor Collaborator
Mehmet Esref Ulutas Van Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29 — View Citation

Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. d — View Citation

Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Apr 4. doi: 10.1007/s10029-024-03004-0. Online — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary rate of postoperative mortality postoperative 24 hours
Secondary rate of urinary retansion postoperative 24 hours
Secondary rate of postoperative pain postoperative 24 hours
Secondary Rate of Hernia recurrence first year
Secondary Rate of Postoperative complications such as wound infection, bleeding postoperative 24 hours and 1st month
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