Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
1 other identifier
interventional
177
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2019
CompletedFirst Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedNovember 5, 2019
October 1, 2019
2.9 years
October 14, 2019
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
adequacy of different techniques
6 months to one year
Surgical Site Occurrence (SSO)
6 months to one year
Hernia Reoccurence
6 months to one year
Study Arms (3)
group1
EXPERIMENTALunderwent laparoscopic IPOM hernioplasty without repair
group2
EXPERIMENTALunderwent laparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS
group3
EXPERIMENTALunderwent laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0
Interventions
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 .
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
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.
Eligibility Criteria
You may qualify if:
- patients over 18 years undergoing surgery for primary or incisional ventral hernia
- defect whose major axis not exceeding 12cm.
You may not qualify if:
- Patients undergoing revision
- Emergency surgery.
- Parastomal hernias were not included.
- Patients not candidate for laparoscopy including cardiac and COPD patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig Unversity
Zagazig, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant profeosser
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 23, 2019
Study Start
October 3, 2016
Primary Completion
August 30, 2019
Study Completion
September 29, 2019
Last Updated
November 5, 2019
Record last verified: 2019-10