Hernia Clinical Trial
Official title:
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. A Randomized Controlled Trial
Verified date | October 2019 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.
Status | Completed |
Enrollment | 177 |
Est. completion date | September 29, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients over 18 years undergoing surgery for primary or incisional ventral hernia - defect whose major axis not exceeding 12cm. Exclusion Criteria: - Patients undergoing revision - Emergency surgery. - Parastomal hernias were not included. - Patients not candidate for laparoscopy including cardiac and COPD patients |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig Unversity | Zagazig |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post operative complications | Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery | 6 months | |
Secondary | adequacy of different techniques | Surgical Site Infection (SSI) CDC definition | 6 months to one year | |
Secondary | Surgical Site Occurrence (SSO) | Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam | 6 months to one year | |
Secondary | Hernia Reoccurence | A hernia that was repaired in the past but has returned | 6 months to one year |
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