Northwestern University
The goal of this clinical trial is to learn whether slowly dissolving stitches work as well as permanent stitches for repairing a groin (inguinal) hernia in adults using the Shouldice technique, a hernia repair that does not use mesh. Researchers think dissolving stitches may cause less long-term groin discomfort without making the hernia more likely to come back. The main questions it aims to answer are: Is the chance of the hernia coming back within 1 year different with dissolving stitches (PDS) compared with permanent stitches (Prolene)? Do the two types of stitches differ in complications, groin pain, quality of life, or the feeling of something foreign in the groin? Is a larger future study of this question possible? This includes whether enough people join, whether the study plan is followed, and whether participants complete follow-up. Researchers will compare slowly dissolving polydioxanone (PDS) stitches with permanent polypropylene (Prolene) stitches to see if the hernia comes back at similar rates and if patients have less long-term discomfort. Participants will: Have their planned open Shouldice hernia repair. The type of stitch will be chosen at random, like flipping a coin, during surgery. Not be told which stitch they received until 1 year after surgery, or sooner if the hernia comes back or another operation is needed. Complete questionnaires about pain, activity, and quality of life before surgery and about 30 days, 6 months, and 1 year after surgery. See their surgeon for routine visits about 30 days and 1 year after surgery. Receive one research phone call about 6 months after surgery. Answer whether they feel something foreign in their groin and which type of stitch they think they received.
Background: The Shouldice repair is a non-mesh inguinal hernia repair that reconstructs the posterior inguinal wall in four continuous suture layers. It is traditionally performed with permanent suture. Permanent suture leaves foreign material in the groin that may contribute to foreign body sensation and chronic groin pain. Slowly absorbable polydioxanone retains tensile strength through the early healing period before it is absorbed. Stainless-steel sutures used in Shouldice repairs have been observed to fracture over time. This raises the possibility that permanent suture strength may not b…
Inclusion Criteria: * Male or female patients 18 years or older * Symptomatic unilateral inguinal hernia * BMI 30 or less * Ability to provide informed consent * Must speak and understand English Exclusion Criteria: * Urgent or emergent presentations * Contaminated cases * Prior inguinal hernia repairs done on side of presenting symptomatic hernia * Femoral hernias * Adults unable to consent * Pregnant patients * Bilateral inguinal hernia repairs
Permanent monofilament polypropylene suture used to complete all four layers of an open Shouldice inguinal hernia repair.
Slowly absorbable monofilament polydioxanone suture used to complete all four layers of an open Shouldice inguinal hernia repair.