Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy

Brief summary (from the registry)

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.

Study details

Official title

Chronic Significant Pain and Functional Outcome After Laparoscopic Versus Open Groin Hernia Mesh Repair: Design of a Randomized Controlled Clinical Trial

Conditions

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

Interventions

• Procedure: Laparoscopic totally extraperitoneal inguinal hernia repair
• Procedure: Open tension free inguinal hernia mesh repair

Sponsor

University Hospital, Geneva

Start date

2008-04

Primary completion

2011-04

Sex

Male

Age range

from 21 Years to 70 Years

Results posted

No results posted in this snapshot

Countries

Switzerland

Total sites listed

1

Eligibility criteria