Umbilical Hernial Repair Using IPOM
Primary Purpose
Umbilical Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
umbilical herneal repair
Sponsored by
About this trial
This is an interventional treatment trial for Umbilical Hernia
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 pregnancy incarcerated hernia recurrent hernia
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cirrhotic patient
Arm Description
cirrhotic patient with umbilical hernia to be operated
Outcomes
Primary Outcome Measures
early wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
late wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Secondary Outcome Measures
Full Information
NCT ID
NCT04088253
First Posted
September 11, 2019
Last Updated
September 11, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04088253
Brief Title
Umbilical Hernial Repair Using IPOM
Official Title
Local Repair of Umbilical Hernia in Cirrhotic Patient Using Intraperitoneal Onlay Mesh Technique
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Detailed Description
Umbilical hernia is common in cirrhotic patients suffering from ascites, with a prevalence up to 20%, which is 10 times higher than in the general population. Ascites is the major predisposing factor since it causes muscle wasting and increases intra-abdominal pressure. A unique feature of cirrhosis is low physiologic reserve, which increases the risk of death from complications of umbilical hernia and makes the patient more vulnerable to perioperative complications during repair. Because of the high operative risk, umbilical hernia repair has traditionally been reserved for the most complicated cases, such as strangulation of the bowel or rupture of the skin with leakage of ascitic fluid Many patients are thus managed conservatively, with watchful waiting. However, the natural course of umbilical hernia tends toward complications (eg, bowel incarceration, rupture of the overlying skin), which necessitate urgent repair. The risk of death with hernia repair in this urgent setting is seven times higher than for elective hernia repair in cirrhotic patients. More recent data indicate that elective repair in patients with well-compensated cirrhosis carries complication and mortality rates similar to those in noncirrhotic patients. Therefore, patients who should undergo umbilical hernia repair are not only those with complicated umbilical hernia (strangulation or ascites leak), but also those with well-compensated cirrhosis at risk of complications. Factors that pose a particularly high risk of complications of repair are large hernia (> 5 cm), hernia associated with pain, intermittent incarceration, and trophic alterations of the overlying skin. In these patients, elective repair should be considered if hepatic function is preserved, if ascites is well managed (sodium restriction, diuretics, and sometimes even preoperative transjugular intrahepatic portosystemic shunt placement), and if the patient is not expected to undergo liver transplantation in the near future. If liver transplantation is anticipated in the short term, umbilical hernia can be managed concomitantly. Management of ascites after umbilical hernia repair is essential for prevention of recurrence.
Aim of Work This study is aiming to assess the outcome of local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Surgical Steps:
small skin incision over the hernia. Dissection and division the hernia sac
Reduction of the contents of the sac into the abdomen and excision of the redundant hernia sac.
Insertion of a finger or peanut sponge into the defect to clear the underside of the peritoneum of adhesions or bowel. Clear enough space around the defect to place a patch twice the size of the hernia defect.
Complete immersion of the mesh (in sterile saline for 1-3 seconds) immediately prior to placement in order to maximize the flexibility of the prosthesis.
Insertion of a small retractor into the defect to pull anterior and cephalad to make room for the mesh. Choose either the small, medium or large patch to insert into the defect. The chosen patch size should be approximately twice the size of the hernia defect. Gently fold or roll the patch parallel to the opening between the strap with the barrier side facing out carefully avoiding any sharp folding or kinking that might compromise the memory ring. Care should also be taken not to cut or nick the memory recoil ring. Gently insert the patch all the way through the defect and into the intraabdominal space, using an atraumatic clamp. Prevent the patch from touching the patients skin.
Remove the clamp and the small retractor. The memory recoil ring will allow the patch to "pop open." Gently pull up on the looped positioning strap until the patch rests against the abdominal wall without pulling harder than necessary. This allows the patch to evenly rest tension-free against the abdominal wall in all four quadrants.
While gently pulling up on the looped positioning strap, use a retractor to peer in between the anterior portion of the patch and the peritoneum to ensure that no tissue such as a bowel or omentum is caught between the patch and the abdominal wall Gently separate the two straps to allow access to the inner positioning pocket to ensure that the patch is lying flat in the intraabdominal space, against the anterior abdominal wall Utilizing the anterior mesh straps and pocket, place interrupted U-stitches in a minimum of two quadrants for the small patch (4.3 cm) and in four quadrants for the medium (6.4 cm) and large (8.0 cm) patches.
Care should be taken to ensure the sutures secure the fascia to the anterior polypropylene pocket only. For the appropriate amount of sutures follow your surgical judgement and adjust to specific patient needs.
Use nonabsorbable sutures to secure the patch by suturing the positioning straps to the margins of the defect. Cut off the excess positioning straps and discard. The patch recoil technology and abdominal pressure will ensure that the patch lies flat Reapproximate the fascia and then close the subcutaneous tissues. Lastly, reapproximate the wound
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cirrhotic patient
Arm Type
Experimental
Arm Description
cirrhotic patient with umbilical hernia to be operated
Intervention Type
Procedure
Intervention Name(s)
umbilical herneal repair
Intervention Description
reduction of the herneal content an repair of the defect with IPOM
Primary Outcome Measure Information:
Title
early wound complications
Description
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Time Frame
1 weak
Title
late wound complications
Description
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 pregnancy incarcerated hernia recurrent hernia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hossam zaher
Phone
+201069369274
Email
hossamzaher3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Soliman
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
age, sex , clinical diagnosis
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
age, sex , clinical diagnosis
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Umbilical Hernial Repair Using IPOM
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