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Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

U

Uppsala University Hospital

Status

Completed

Conditions

Hernia, Inguinal

Treatments

Procedure: Mesh repair for primary inguinal hernia

Study type

Interventional

Funder types

Other

Identifiers

NCT01020058
2004:M-360

Details and patient eligibility

About

The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

Enrollment

384 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Unilateral inguinal hernia
  • suitable for open mesh repair in local anesthesia as well as laparoscopic repair
  • ASA score I-III
  • informed consent

Exclusion criteria

  • ASA score IV (not suitable for TEP)
  • bilateral hernias (laparoscopic repair preferable)
  • recurrent hernia (primary repair affects preferable treatment)
  • large scrotal hernias (not suitable for local anesthesia)
  • earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

384 participants in 2 patient groups

Lichtenstein in local anesthesia (LLA)
Active Comparator group
Description:
Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
Treatment:
Procedure: Mesh repair for primary inguinal hernia
TEP
Active Comparator group
Description:
Patient receives a totally extraperitoneal laparoscopic repair
Treatment:
Procedure: Mesh repair for primary inguinal hernia

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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