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Effects of Hernia Repair on Men's Sexual Functions

Primary Purpose

Hernia, Inguinal, Men, Sexual Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Inguinal Hernia Repair

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Laparoscopic hernia repair.

Open hernia repair.

Arm Description

Intervention: inguinal hernia repair.

Outcomes

Primary Outcome Measures

IIEF Scale

international index of erectile functions

Secondary Outcome Measures

SF36

health survey scoring demonstration

Full Information

NCT ID

NCT03326700

First Posted

October 22, 2017

Last Updated

October 25, 2017

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

1. Study Identification

Unique Protocol Identification Number

NCT03326700

Brief Title

Effects of Hernia Repair on Men's Sexual Functions

Official Title

Effects of Laparoscopic Totally Extraperitoneal and Lichtenstein Hernia Repair on Men's Sexual Functions and Quality of Life.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Inguinal, Men, Sexual Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

176 men with unilateral inguinal hernia were randomized in two groups. Group T(n=88) were operated TEP and Group L(n:88) were operated by 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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic hernia repair.

Arm Type

Active Comparator

Arm Description

Intervention: inguinal hernia repair.

Arm Title

Open hernia repair.

Arm Type

Active Comparator

Arm Description

Intervention: inguinal hernia repair.

Intervention Type

Procedure

Intervention Name(s)

Inguinal Hernia Repair

Intervention Description

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.

Primary Outcome Measure Information:

Title

IIEF Scale

Description

international index of erectile functions

Time Frame

7 to 90 days

Secondary Outcome Measure Information:

Title

SF36

Description

health survey scoring demonstration

Time Frame

7 to 90 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We can share study data only without patients names.

Citations:

PubMed Identifier

28727632

Citation

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.

Results Reference

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Effects of Hernia Repair on Men's Sexual Functions

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