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To evaluate a prospective, single-center, randomized, open, parallel controlled clinical study of BD hernia fixation tape for preventing postoperative recurrence and complications of inguinal hernia

To evaluate a prospective, single-center, randomized, open, parallel controlled clinical study of BD hernia fixation tape for preventing postoperative recurrence and complications of inguinal hernia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091382
Enrollment
Unknown
Registered
2024-10-28
Start date
2023-03-06
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Inguinal hernia

Interventions

Experimental group:After inguinal hernia surgery, patients should wear the BD hernia fixation band correctly for 2-4 weeks.
Control group 1:A 0.5kg sandbag /500ml bag filled with 0.9% sodium chloride solution was used to compress the inguinal region of the patients after inguinal hernia surgery for 1 week.
Control group 2:The lower abdomen of postoperative inguinal hernia patients was bandaged and compressed with other brands of common hernia belts, which were worn for 2-4 weeks.

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged 18 years old or over; (2) Unilateral hernia surgery; (3) Willing and able to complete all study procedures and follow the entire study process, including any follow-up (if required); (4) Patients who are willing to provide written informed consent, or whose legally authorized guardian is able to provide written informed consent.

Exclusion criteria

Exclusion criteria: (1) Recurrent hernia. (2) Bilateral hernia. (3) Inguinal hernia repair is performed at the same time as other operations. (4) Necrosis of the femoral head, local skin infection or local skin disease. (5) Apply biological patches. (6) Other types of complications occurred during or after the operation, such as hematoma, urinary retention, intestinal injury, patch infection, postoperative bleeding, major organ dysfunction and other serious complications. (7) During pregnancy or lactation (self-reported); (8) Participating in clinical trials of other drugs or medical devices within three months prior to or before enrollment; (9) Previous medical history combined with serious organ dysfunction, such as cirrhosis, renal insufficiency, etc.; (10) Other situations in which the investigator considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
The area of seroma 30 days after operation was collected and evaluated in 3 treatment groups.;

Secondary

MeasureTime frame
Carolina's Comfort Scale (CCS) was used to assess patients' quality of life after hernia repair.;The patients' satisfaction with the postoperative treatment (HWD & Control methods) will be observed. ;The patients' postoperative pain will be evaluated based on the VAS questionnaire;Postoperative eromas area will be measured by ultrasonography at 90 days after operation;Clinical diagnosis of postoperative recurrence;

Countries

China

Contacts

Public ContactWang Minggang

Beijing Chaoyang Hospital, Capital Medical University

wmgonly@126.com+86 139 1062 7381

Outcome results

None listed

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