Effects of Hernia Repair on Men's Sexual Functions

NCT03326700 | Completed DMC

• 1 other identifier: SEEAH 2015 / 568
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hernia, Inguinal; Men; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• IIEF Scale

  international index of erectile functions

  7 to 90 days

Secondary Outcomes (1)

• SF36

  7 to 90 days

Study Arms (2)

Laparoscopic hernia repair.

ACTIVE COMPARATOR

Intervention: inguinal hernia repair.

Procedure: Inguinal Hernia Repair

Open hernia repair.

ACTIVE COMPARATOR

Intervention: inguinal hernia repair.

Procedure: Inguinal Hernia Repair

Interventions

Inguinal Hernia Repair PROCEDURE

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.

Laparoscopic hernia repair.; Open hernia repair.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having male gender
• patients diagnosed on unilateral inguinal hernia
• patients aged between 18 and 65 years
• ASA I and II patients

You may not qualify if:

• having female gender
• patients diagnosed on bilateral or recurrence inguinal hernia,
• patients suffering erectile dysfunction

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Related 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.

  PMID: 28727632 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Multiple Endocrine Neoplasia Type 1; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 31, 2017
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share