Clinical trial NCT06061068: Hernia Belt in Laparoscopic Inguinal Hernia Repair
Official title: The Effect of Hernia Belt on Postoperative Complications and Quality of Life for Patients Who Underwent Laparoscopic Inguinal Hernia Repair:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Recurrence
Seroma Following Procedure
Pain, Postoperative
Quality of Life
Keywords: Laparoscopic inguinal hernia repair
Hernia belt
Hernia recurrence
Seroma Following Procedure
Pain, Postoperative
Quality of Life
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guang'an People's Hospital
name: Pengan County People's Hospital
name: People's Hospital of Yilong County
name: Nanbu Hospital of County Chinese Medicine
First posted: 2023-09-29
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hernia recurrence
timeFrame: 1 month,3 months,6 months and 12 months after surgery.
measure: Postoperative complications
timeFrame: Within 3 months after surgery.
measure: Pain score
timeFrame: 1 day,7 days,1 month and 3 months after surgery.
measure: Health-related quality of life
timeFrame: 1 day,7 days,1 month and 3 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References: