Study of Laparoscopic Inguinal Hernia Repair

NCT02920307 | Completed DMC

• 1 other identifier: MK-002-LHR
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Conditions

Hernia, Inguinal; Inguinal Hernia, Direct; Inguinal Hernia, Indirect; Hernia, Femoral; Recurrence; Neuralgia, Atypical; Neuralgia, Ilioinguinal; Neuralgia, Iliohypogastric Nerve

Keywords

laparoscopic inguinal hernia repair; total extraperitoneoscopic hernia repair; transabdominal preperitoneal hernia repair; inguinal hernia; laparoscopy; hernia repair; herniorraphy; laparoscopic surgery

Outcome Measures

Primary Outcomes (6)

• Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS)

  neuralgia, inguinal

  preoperative and postoperative 2nd year

• Change from preoperative pain levels at 1 year assessed by the VAS

  neuralgia, inguinal

  preoperative and postoperative 1st year

• Change from preoperative pain levels at 6 months assessed by the VAS

  neuralgia, inguinal

  preoperative and postoperative 6th month

• Change from preoperative pain levels at 3 months assessed by the VAS

  neuralgia, inguinal

  preoperative and postoperative 3th month

• Change from preoperative pain levels at 1 month assessed by the VAS

  neuralgia, inguinal

  preoperative and postoperative 1 month

• Change from preoperative pain levels at 1 week assessed by the VAS

  neuralgia, inguinal

  preoperative and postoperative 1th week

Secondary Outcomes (4)

• Total hospital costs

  up to 24 months

• conversion rate

  through the first day

• recurrence rate

  up to 24 months

• rate of minor and major complications

  2 year

Study Arms (4)

TEP without fixation

EXPERIMENTAL

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation

Procedure: TEP without fixation

TEP with fixation

ACTIVE COMPARATOR

Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair

Procedure: TEP with fixation

TAPP without fixation

EXPERIMENTAL

Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation

Procedure: TAPP without fixation

TAPP with fixation

ACTIVE COMPARATOR

Standard transabdominal preperitoneal (TAPP) hernia repair

Procedure: TAPP with fixation

Interventions

TEP without fixation PROCEDURE

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Also known as: TEP no fixation

TEP without fixation

TEP with fixation PROCEDURE

Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair

Also known as: Standard TEP

TEP with fixation

TAPP without fixation PROCEDURE

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation

Also known as: TAPP no fixation

TAPP without fixation

TAPP with fixation PROCEDURE

Standard transabdominal preperitoneal (TAPP) inguinal hernia repair

Also known as: Standard TAPP

TAPP with fixation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral hernia
• uncomplicated hernia
• medical fitness for general anesthesia

You may not qualify if:

• unfit for general anesthesia
• complicated hernia
• uncorrectable coagulopathy
• BMI \> 35
• concomitant pathologies requiring simultaneous surgery
• bilateral hernia

Sponsors & Collaborators

• Medical Park Gaziantep Hospital: lead
• Muğla Sıtkı Koçman University: collaborator
• Bahçeşehir University: collaborator

Study Sites (1)

Medical Park Gaziantep Hospital

Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Recurrence; Neuralgia

Interventions

tetraethylpyrazine; tetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mehmet Kaplan, M.D.

  Bahçeşehir Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

• Onder Ozcan, M.D.

  Mugla University, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 30, 2016
• Study Start: May 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)