200 Participants NeededMy employer runs this trial

Dissolving vs Permanent Stitches for Inguinal Hernia

MM
MN
Overseen ByMaria Narvaez Pereyra, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of stitches, dissolving and permanent, to determine which is more effective for repairing a groin hernia without mesh. Researchers aim to discover if dissolving stitches (Polydioxanone suture, PDS) cause less long-term discomfort and are equally effective at preventing hernia recurrence within a year. The trial is open to adults with a single-sided groin hernia who can consent and have a BMI of 30 or less. Participants will have their hernia repaired using one of the stitch types, chosen randomly during surgery, and will complete follow-up visits and questionnaires about their recovery and quality of life. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future hernia repair techniques.

What prior data suggests that these stitches are safe for hernia repair?

Research has shown that polydioxanone (PDS) stitches are generally safe and might cause less groin pain after surgery compared to nonabsorbable stitches like polypropylene (Prolene). Studies have found that PDS stitches can reduce the risk of wound problems, making them a well-accepted choice for hernia repairs.

In contrast, Prolene stitches, which remain in the body permanently, have been linked to more cases of long-term groin pain after surgery. Despite this, they are often used for their strength and durability.

Overall, both types of stitches are safely used in hernia repairs, but PDS stitches might help reduce discomfort after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because they want to find out whether dissolving stitches, like polydioxanone (PDS), offer better outcomes than permanent stitches, such as polypropylene (Prolene), for inguinal hernia repairs. Unlike permanent stitches, which stay in the body indefinitely, PDS stitches gradually dissolve over time, potentially reducing the risk of long-term complications like infection or discomfort. This trial could highlight whether PDS offers quicker recovery and fewer issues compared to the traditional permanent options, sparking interest in refining surgical techniques for improved patient care.

What evidence suggests that this trial's treatments could be effective for inguinal hernia repair?

This trial will compare polydioxanone (PDS) stitches, which dissolve slowly, with polypropylene (Prolene) stitches, which are permanent, in inguinal hernia repairs. Research has shown that PDS stitches might reduce long-term discomfort after hernia repairs. Early findings suggest that dissolving stitches like PDS could lessen the sensation of having a foreign object in the body, a common issue with permanent stitches. In contrast, Prolene stitches have been widely used in hernia repairs and have consistently prevented hernias from returning. While Prolene is trusted for its effectiveness in stopping hernias from recurring, researchers in this trial are exploring whether PDS can offer similar benefits with less discomfort.678910

Who Is on the Research Team?

MM

Megan Melland-Smith, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults who need open groin (inguinal) hernia repair using the Shouldice technique without mesh. Participants must be able to complete follow-up visits and questionnaires. Specific inclusion or exclusion criteria are not detailed.

Inclusion Criteria

BMI 30 or less
Ability to provide informed consent
Must speak and understand English
See 2 more

Exclusion Criteria

Urgent or emergent presentations
I have had hernia repair surgery on the same side as my current hernia symptoms.
Pregnant patients
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open Shouldice hernia repair with randomized suture type (PDS or Prolene)

Day of surgery
1 visit (in-person)

Follow-up

Participants complete questionnaires and attend routine visits to monitor for hernia recurrence and assess quality of life

12 months
Visits at 30 days, 6 months, and 12 months (in-person and phone call)

Long-term Follow-up

Participants are monitored for long-term outcomes such as hernia recurrence and chronic pain

1 year (+/- 2 months)

What Are the Treatments Tested in This Trial?

Interventions

  • Polydioxanone suture (PDS)
  • Polypropylene suture (Prolene)

Trial Overview

The study compares two types of stitches used in hernia surgery: slowly dissolving polydioxanone (PDS) versus permanent polypropylene (Prolene). Patients are randomly assigned to one type during their operation, and neither they nor their doctors know which was used until a year later.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PDSExperimental Treatment1 Intervention
Group II: ProleneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Citations

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