Trial Outcomes & Findings for Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair (NCT NCT01953302)
NCT ID: NCT01953302
Last Updated: 2024-04-12
Results Overview
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
four weeks after the surgery
Results posted on
2024-04-12
Participant Flow
Participant milestones
| Measure |
Modified "Open Mesh Technique"
We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
modified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
Baseline characteristics by cohort
| Measure |
Modified "Open Mesh Technique"
n=124 Participants
We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
modified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: four weeks after the surgerywe counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
Outcome measures
| Measure |
Modified "Open Mesh Technique"
n=124 Participants
We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
modified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
|
|---|---|
|
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
Infection
|
9 participants
|
|
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
Seroma
|
21 participants
|
|
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
Hematoma
|
2 participants
|
|
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
No complications
|
92 participants
|
SECONDARY outcome
Timeframe: up to 36 months after the surgeryOutcome measures
| Measure |
Modified "Open Mesh Technique"
n=124 Participants
We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
modified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
|
|---|---|
|
Number of Patients With Postoperative Hernia Recurrence
Reccurence with early complications
|
7 Participants
|
|
Number of Patients With Postoperative Hernia Recurrence
Reccurence with infection
|
4 Participants
|
|
Number of Patients With Postoperative Hernia Recurrence
No reccurence
|
113 Participants
|
Adverse Events
Modified "Open Mesh Technique"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place