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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03326700
Other study ID # SEEAH 2015 / 568
Secondary ID
Status Completed
Phase N/A
First received October 22, 2017
Last updated October 25, 2017
Start date November 2015
Est. completion date May 2017

Study information

Verified date October 2017
Source Okmeydani Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Our aim was to study the sexual functions of men, who underwent TEP or LH repair according to Health Survey Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).


Description:

176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88) underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date May 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- having male gender

- patients diagnosed on unilateral inguinal hernia

- patients aged between 18 and 65 years

- ASA I and II patients

Exclusion Criteria:

- having female gender

- patients diagnosed on bilateral or recurrence inguinal hernia,

- patients suffering erectile dysfunction

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Inguinal Hernia Repair
Inguinal hernia repair is surgery to repair a hernia in the groin. A hernia is tissue that bulges out of a weak spot in the abdominal wall. The intestine may bulge out through this weakened area. During surgery to repair the hernia, the bulging tissue is pushed back in. The abdominal wall is strengthened and supported with sutures (stitches), and sometimes mesh. This repair can be done with open or laparoscopic surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Okmeydani Training and Research Hospital

References & Publications (1)

Kushwaha JK, Enny LE, Anand A, Sonkar AA, Kumar A, Pahwa HS. A Prospective Randomized Controlled Trial Comparing Quality of Life Following Endoscopic Totally Extraperitoneal (TEP) Versus Open Stoppa Inguinal Hernioplasty. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):257-261. doi: 10.1097/SLE.0000000000000450. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IIEF Scale international index of erectile functions 7 to 90 days
Secondary SF36 health survey scoring demonstration 7 to 90 days
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