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

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

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 surgery

we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time

Outcome measures

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 surgery

Outcome measures

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 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

Alen Pajtak

Varazdin General Hospital

Phone: +38542393053

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place