Umbilical Hernia
Conditions
Keywords
umbilical hernia,, wound complications,, mesh repair, IPOM,, quality of life,, sublay mesh repair,, recurrence rate
Brief summary
This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.
Interventions
PROCEDUREintraperitoneal onlay mesh repair
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
PROCEDUREsublay mesh repair
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
Sponsors
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
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
* informed consent * patient age: ≥ 18 years * elective surgery for umbilical hernia * hernia diameter ≥ 1cm
Exclusion criteria
* previous history of median laparotomy * navel site infection * contraindication for general anaesthesia * American Society of Anesthesiologists (ASA) score \>IV * pregnancy * cirrhosis of the liver (CHILD B and C) and/or ascites * cytostatic therapy * incarcerated hernia * recurrent hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early wound complications | 30 days after operation | * wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma |
| late wound complications | 1 year after operation | * wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital stay | will be measured after discharge of the patient | measured in days |
| umbilical hernia recurrence rate | 30 days | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan |
| navel site seroma | discharge day | the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm)) |
| complication rate perioperative | intraoperative complications will be recorded immediately after finishing the operation | * major bleeding * bowel injury |
| pain score (Visual Analog Scale - VAS) | 24h post operative | will be measured by the nurse according to Visual Analog Scale |
| Quality of life (SF-36) | 1 day pre-operative | patients will be asked to fulfill validated SF-36 questionnaire |
| complication rate postoperative | 30 day | * trocar site hernia * enteral fistula * persistent pain * re-operation |
| duration of operation | the duration will be recorded immediately after finishing the operation | measured in minutes according to operations protocol (duration cut - suture) |
Countries
Germany, Switzerland
Outcome results
None listed