RECRUITING

Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Inguinal Hernia Repair

Talk to us

Conditions

Chronic Groin PainHernia, InguinalChronic pain groin

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is evaluating the management of chronic post-operative inguinal hernia pain and the impact of hernia mesh removal after previous minimally invasive inguinal hernia repairs. The study aims are to evaluate the change in chronic (\>6 months), nociceptive, postoperative inguinal pain after mesh removal compared to no mesh removal in patients who have previously undergone minimally invasive inguinal hernia repair with pre-peritoneal mesh.

Official Title

Mesh Removal Versus No Mesh Removal for Chronic Groin Pain After Minimally Invasive Inguinal Hernia Repair: A Randomized Controlled Trial

Quick Facts

Study Start:2022-07-25
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05484635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 18 years of age
  2. * CPIP lasting \> 6 months after laparoscopic or robotic inguinal hernia repair with pre-peritoneal mesh
  3. * Must exhibit 1 or more of the following characteristics of nociceptive pain:
  4. * Pain while sitting in a chair for prolonged periods of time with relief when extending the hip or lying supine to straighten the leg
  5. * Severe pain when crossing the affected leg over the contralateral leg
  6. * "Foreign body sensation" or "tightness" in the groin
  7. * Does not have a maximum trigger point for pain
  8. * Lacks characteristics of neuropathic pain (sharp, burning, shooting, paresthesias, allodynia, hyperalgesia, etc.)
  9. * Moderate to severe pain \[4-10\] when moving from supine to standing on NRS
  1. * No characteristics of nociceptive groin pain
  2. * Zero or mild pain \[0-3\] when moving from supine to standing on NRS
  3. * Recurrent inguinal hernia detected on clinical exam
  4. * Large, femoral, direct or indirect inguinal hernia (F2-3, M2-3, L2-3) on diagnostic laparoscopy as defined by European Hernia Society (EHS) classification
  5. * Prior open (anterior) approach to inguinal hernia repair (i.e. Lichtenstein)
  6. * Prior mesh plugs or Prolene Hernia Systems
  7. * History of prostatectomy or vascular procedures in the pelvis or groin

Contacts and Locations

Study Contact

David Krpata, MD
CONTACT
216-445-9989
krpatad@ccf.org

Principal Investigator

David Krpata, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: David Krpata

  • David Krpata, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-25
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2022-07-25
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Chronic groin pain
  • Hernia, Inguinal
  • Chronic pain groin

Additional Relevant MeSH Terms

  • Chronic Groin Pain
  • Hernia, Inguinal