Open mesh groin hernia repair in women - a comparison of two surgical methods

Open anterior mesh repair versus modified open anterior mesh repair for groin hernia in women. A double blinded randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10330683

Enrollment

490

Registered

2019-06-10

Start date

2019-10-07

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Groin hernia Digestive System Inguinal hernia and femoral hernia

Interventions

Current interventions as of 20/07/2020: All patients will be physically examined for the presence of a groin hernia. All patients will be operated for their groin hernia. Two techniques will be used.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Primary, reducible groin hernia 3. ASA class 1-2

Exclusion criteria

Exclusion criteria: 1. Recurrent hernia 2. Alcohol or substance abuse 3. Known or suspected coagulopathy

Design outcomes

Primary

Measure	Time frame
Recurrence will be determined by a blinded observer through physical examination at 1 and 3 years. In unclear cases, ultrasonography will be used in addition to the physical examination.	—

Secondary

Measure	Time frame
1. Postoperative complications will be determined through physical examination by a blinded observer at 2 weeks. 2. Self-Assessed health status will be measured using a health thermometer where 0 represents the worst imaginable health, and 100 represents the best imaginable health. This is done preoperatively, at 2 weeks, 1 year and 3 years. 3. Patient satisfaction will be measured through asking the study participants "are you satisfied with the result of the operation?" as well as "are your level of groin symptoms less, the same or worse compared to before the surgery?". This is done at 1 and 3 years. 4. Cost and cost-effectiveness of the interventions will be calculated in terms of cost in USD per DALY averted. The IPQ results will be translated into disability weights for DALY calculation. Costs will be assessed from the providers perspective, including information on materials and medicines, staff costs, capital costs and overhead costs. 5. Chronic pain will be measured using the Inguinal Pain Questionnaire. Level of pain will be assessed before the operation, and at 1 and 3 years postoperatively	—

Measure

Time frame

1. Postoperative complications will be determined through physical examination by a blinded observer at 2 weeks. 2. Self-Assessed health status will be measured using a health thermometer where 0 represents the worst imaginable health, and 100 represents the best imaginable health. This is done preoperatively, at 2 weeks, 1 year and 3 years. 3. Patient satisfaction will be measured through asking the study participants "are you satisfied with the result of the operation?" as well as "are your level of groin symptoms less, the same or worse compared to before the surgery?". This is done at 1 and 3 years. 4. Cost and cost-effectiveness of the interventions will be calculated in terms of cost in USD per DALY averted. The IPQ results will be translated into disability weights for DALY calculation. Costs will be assessed from the providers perspective, including information on materials and medicines, staff costs, capital costs and overhead costs. 5. Chronic pain will be measured using the Inguinal Pain Questionnaire. Level of pain will be assessed before the operation, and at 1 and 3 years postoperatively

—

Countries

Uganda

Contacts

Public ContactJenny Löfgren

jenny.lofgren@ki.se+46 704 612426

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026