Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
Primary Purpose
Hernia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic (IPOM) hernioplasty without repair
aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS
laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
Sponsored by
About this trial
This is an interventional treatment trial for Hernia focused on measuring ventral hernia - LVHR-transfacial repair
Eligibility Criteria
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
Sites / Locations
- Zagazig Unversity
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
group1
group2
group3
Arm Description
underwent laparoscopic IPOM hernioplasty without repair
underwent laparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS
underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
adequacy of different techniques
Surgical Site Infection (SSI) CDC definition
Surgical Site Occurrence (SSO)
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam
Hernia Reoccurence
A hernia that was repaired in the past but has returned
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04137172
Brief Title
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
Official Title
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
ventral hernia - LVHR-transfacial repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group1
Arm Type
Experimental
Arm Description
underwent laparoscopic IPOM hernioplasty without repair
Arm Title
group2
Arm Type
Experimental
Arm Description
underwent laparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS
Arm Title
group3
Arm Type
Experimental
Arm Description
underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
Intervention Type
Procedure
Intervention Name(s)
laparoscopic (IPOM) hernioplasty without repair
Intervention Description
Under general anesthesia, supine position, lateral visiport 12mm was inserted at the left anterior axillary line . Other two 5mm ports were inserted under vision. A 30-degree optics were used. Adhesiolysis was done . The contents of hernia were reduced . The borders of the defect were illuminated and outlined. The abdominal wall was marked from outside for measurement of defect size and for corners fixation of mesh with 5cm away from defect edge. Defect with axis from 9 to 12 cm is considered big defect.
Group I:
Proline (1) sutures were applied at the corners of the mesh introduced into the peritoneal cavity. Endoclose passed at the marked site from abdominal wall, sutures hanged and tied subcutaneously, completion of mesh fixation using secure strap .
Intervention Type
Procedure
Intervention Name(s)
aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS
Intervention Description
Group II:
Using PDS 0, a stratifix suture (STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device) versus proline 1 , used to repair and plicate the defect then mesh fixation
Intervention Type
Procedure
Intervention Name(s)
laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
Intervention Description
The PDS loop sutures were prepared by cutting the needles, keeping two detached ends and one blind end. A small curved supraumbilical incision was done. The endoclose passed through upper border of incision penetrating the abdominal wall above the defect, hanging the blind end of the PDS Loop to outside. It passed through the lower border of the wound crossing the defect. It hanged one detached end of the PDS Loop suture to outside, passed again through lower border of incision to catch the other detached end. The two ends were hanged not tied to avoid incision closure. The process is repeated by passing 1-2 cm lateral or medial to the previous sutures, then blind ends were divided. Lastly, all sutures are tied. Mesh was fixed as before.
Primary Outcome Measure Information:
Title
post operative complications
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
adequacy of different techniques
Description
Surgical Site Infection (SSI) CDC definition
Time Frame
6 months to one year
Title
Surgical Site Occurrence (SSO)
Description
Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam
Time Frame
6 months to one year
Title
Hernia Reoccurence
Description
A hernia that was repaired in the past but has returned
Time Frame
6 months to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zagazig Unversity
City
Zagazig
Country
Egypt
12. IPD Sharing Statement
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Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
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