Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

Study Overview
=================
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.

Official Title
-----------------
Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

Conditions
-----------------
Umbilical Hernia

Intervention / Treatment
-----------------
* Procedure: intraperitoneal onlay mesh repair
* Procedure: sublay mesh repair


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intraperitoneal onlay mesh repair<br> | Procedure: intraperitoneal onlay mesh repair<br>* 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.<br>|
| Active Comparator: sublay mesh repair<br> | Procedure: sublay mesh repair<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early wound complications | wound infection (with or without removal of the mesh) wound necrosis wound hematoma | 30 days after operation | 
| late wound complications | wound infection (with or without removal of the mesh) wound necrosis wound hematoma | 1 year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate perioperative | major bleeding bowel injury | intraoperative complications will be recorded immediately after finishing the operation | 
| duration of operation | measured in minutes according to operations protocol (duration cut - suture) | the duration will be recorded immediately after finishing the operation | 
| hospital stay | measured in days | will be measured after discharge of the patient | 
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 30 days | 
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 1 year | 
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 3 years | 
| umbilical hernia recurrence rate | the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan | 5 years | 
| navel site seroma | 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)) | discharge day | 
| navel site seroma | 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)) | after 30 days | 
| navel site seroma | 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)) | after 1 year | 
| complication rate postoperative | trocar site hernia enteral fistula persistent pain re-operation | 30 day | 
| complication rate postoperative | trocar site hernia enteral fistula persistent pain re-operation | 1 year | 
| complication rate postoperative | trocar site hernia enteral fistula persistent pain re-operation | 3 years | 
| complication rate postoperative | trocar site hernia enteral fistula persistent pain re-operation | 5 years | 
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | 24h post operative | 
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | 48h post operative | 
| pain score (Visual Analog Scale - VAS) | will be measured by the nurse according to Visual Analog Scale | immediately before discharge | 
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 1 day pre-operative | 
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 30 days postoperatively | 
| Quality of life (SF-36) | patients will be asked to fulfill validated SF-36 questionnaire | 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical hernia,, wound complications,, mesh repair, IPOM,, quality of life,, sublay mesh repair,, recurrence rate