Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy

Summary

Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia repair anymore. Chronic significant post operative pain is a common, clinically relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as well as pain exposure history is showed to be important in the development of chronic significant post operative pain. The objective of this study is to analyse chronic significant post operative pain and the functional outcome status of patients after laparoscopic repair compared to open repair.

Methods: A randomized controlled non-blinded clinical trial is designed to compare open inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic significant post operative pain, pain related sexual function disorders, complications, health related quality of life outcomes, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral or bilateral primary hernia who are candidates for elective surgery and medically fit for general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05 and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in may 2009.

Conditions

• Inguinal Hernia
• Laparoscopic Surgery
• Pain
• Sexual Dysfunction, Physiological

Interventions

PROCEDURE

Laparoscopic totally extraperitoneal inguinal hernia repair

3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.

PROCEDURE

Open tension free inguinal hernia mesh repair

Classical Lichtenstein repair. Polyester flat 14x8cm mesh

Sponsors & Collaborators

• University Hospital, Geneva

  lead OTHER

Principal Investigators

• Philippe Morel, Prof. · Geneva University Hospital, Departement of Surgery, Visceral Surgery Division

• Ihsan INAN, M.D. · Geneva University Hospital, Departement of Surgery, Visceral Surgery Division

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• Switzerland

Study Locations