Hernia Belt in Laparoscopic Inguinal Hernia Repair (NCT06061068) | Clinical Trial Compass
CompletedNot Applicable
Hernia Belt in Laparoscopic Inguinal Hernia Repair
China678 participantsStarted 2023-07-17
Plain-language summary
In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years or order.
. Primary unilateral oblique inguinal hernia, direct hernia, femoral hernia.
. Qualified for laparoscopic Transabdominal preperitoneal approach(TAPP) or Totally extraperitoneal(TEP).
. Eligible to tolerate general anesthesia.
Exclusion criteria
. Incarcerated hernia, recurrent hernia and other types of hernia.
. Patients presenting for obvious contraindications to surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at using a hernia belt after laparoscopic inguinal hernia repair — based on what it found about recurrence and postoperative complications, would a hernia belt be recommended as part of my recovery?
2The study specifically tracked seroma formation as a complication — how common is seroma after this type of repair, and did the trial results suggest a hernia belt helps reduce it?
3Since this trial measured pain scores after surgery, what do the results tell us about how much a hernia belt might affect my postoperative pain compared to not wearing one?
4This study is now completed — have the results been published yet, and if so, what were the main takeaways about quality of life for patients who used a hernia belt versus those who didn't?
5Given that this was a Phase NA (non-drug, device/intervention) study on a laparoscopic procedure I may be having, does the evidence from this trial change anything about the standard recovery protocol you'd normally recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hernia recurrence
Timeframe: 1 month,3 months,6 months and 12 months after surgery.
2
Postoperative complications
Timeframe: Within 3 months after surgery.
3
Pain score
Timeframe: 1 day,7 days,1 month and 3 months after surgery.
4
Health-related quality of life
Timeframe: 1 day,7 days,1 month and 3 months after surgery.