Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

• ClinicalTrials.gov Identifier: NCT05863624
• Recruitment Status: Not yet recruiting
• First Posted: May 18, 2023
• Last Update Posted: March 6, 2024
• Sponsor: Kuopio University Hospital
• Collaborators: Helsinki University Central Hospital; Päijänne Tavastia Central Hospital; North Karelia Central Hospital; Jyväskylä Central Hospital; Mikkeli Central Hospital
• Information provided by (Responsible Party): Kuopio University Hospital

Tracking Information

• First Submitted Date: April 17, 2023
• First Posted Date: May 18, 2023
• Last Update Posted Date: March 6, 2024
• Estimated Study Start Date: September 1, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2023)

Chronic pain [ Time Frame: from 1 week to one year ]

Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 8, 2023)

• Complications [ Time Frame: 1 month ]
  Postoperative complications of surgery (wound infection, hemorrhage)
• Recurrence [ Time Frame: 5 years ]
  Hernia recurrences after 5 years
• Sick leave [ Time Frame: 0-30 days ]
  how many days the patient is not working after surgery
• Treatment costs [ Time Frame: 0-30 days ]
  how much in euros the surgical treatment will cost

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia
• Official Title: Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
• Brief Summary: This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.
• Detailed Description: The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized follow-up study

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Post Operative Pain

Intervention

• Procedure: Open hernioplasty
  Inguinal hernia is operated using open surgery
  Other Name: Open Lichtenstein hernia repair
• Procedure: TEP hernioplasty
  Inguinal hernia is operated using laparoendoscopic technique
  Other Name: totally endoscopic hernia repair (TEP)

Study Arms

• Experimental: Open hernioplasty
  Open Lichtenstein hernia repair
  Intervention: Procedure: Open hernioplasty
• Active Comparator: TEP hernioplasty
  totally endoscopic hernia repair (TEP)
  Intervention: Procedure: TEP hernioplasty

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 8, 2023): 170
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2029
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• primary inguinal hernia in females

Exclusion Criteria:

• emergency operation
• recurrent hernia
• groin pain without hernia
• frail and sick patient ASA ≥ 4

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study includes only females

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hannu EK Paajanen, MD; 0405263101 ext +358; paajanen@surffi.fi

• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT05863624
• Other Study ID Numbers: KUH5200667
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kuopio University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Kuopio University Hospital
• Original Study Sponsor: Same as current

Collaborators

• Helsinki University Central Hospital
• Päijänne Tavastia Central Hospital
• North Karelia Central Hospital
• Jyväskylä Central Hospital
• Mikkeli Central Hospital

• Investigators: Not Provided
• PRS Account: Kuopio University Hospital
• Verification Date: May 2023