Hernia, Inguinal, Pain, Postoperative, Quality of Life, Recurrence, Seroma Following Procedure
Conditions
Keywords
Laparoscopic inguinal hernia repair, Hernia belt, Hernia recurrence, Seroma Following Procedure, Pain, Postoperative, Quality of Life
Brief 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.
Detailed description
Some scholars believe that the use of hernia belts to compress the inguinal region reduces postoperative complications. According to the International Guidelines for the Management of Inguinal Hernia in Adults (2018) interpretation, the incidence of seroma after inguinal hernia repair ranges from 0.5% to 2.2%. However,there is no consensus among different research organizations and clinical staff on the use of hernia belts after laparoscopic inguinal hernia repair. 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.
Interventions
PROCEDUREHernia belt compression
Use the hernia belt to compress the inguinal region
Sponsors
Guang'an People's Hospital
Pengan County People's Hospital
People's Hospital of Yilong County
Nanbu Hospital of County Chinese Medicine
Nanchong Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or order. 2. Primary unilateral oblique inguinal hernia, direct hernia, femoral hernia. 3. Qualified for laparoscopic Transabdominal preperitoneal approach(TAPP) or Totally extraperitoneal(TEP). 4. Eligible to tolerate general anesthesia.
Exclusion criteria
1. Incarcerated hernia, recurrent hernia and other types of hernia. 2. Patients presenting for obvious contraindications to surgery. 3. Need for an open inguinal hernia repair. 4. Difficult to follow-up or communication. 5. Patients who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 1 month,3 months,6 months and 12 months after surgery. | Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence. |
| Postoperative complications | Within 3 months after surgery. | Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone. |
| Pain score | 1 day,7 days,1 month and 3 months after surgery. | The visual analog scale (VAS) was adopted for pain evaluation preoperative,1 day, 7 days, 1 months and 3 months postoperatively.The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.Higher scores mean a worse outcome. |
| Health-related quality of life | 1 day,7 days,1 month and 3 months after surgery. | The 36-item short-form health survey(SF-36) was adopted for Health-related quality of life 1 day, 7 days, 1 months and 3 months postoperatively. SF-36 consists of 36 articles, including 8 areas of physical function, physical role, physical pain, general health status, vitality, social function, emotional role and mental health. |
Countries
China
Outcome results
None listed