Trial Outcomes & Findings for Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate (NCT NCT02457728)

Results Overview

Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

During hospitalization and 6 weeks after surgery.

Results posted on

2015-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Inguinal Herniation In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inguinal Herniation n=34 Participants In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment Austria	34 participants n=5 Participants

PRIMARY outcome

Timeframe: During hospitalization and 6 weeks after surgery.

Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.

Outcome measures

Outcome measures
Measure	Single-port TAPP Repair n=34 Participants LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.	6 participants

Adverse Events

TAPP Repair

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAPP Repair n=34 participants at risk LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
Surgical and medical procedures clogging of device	14.7% 5/34 • Number of events 5 • 2 months
Injury, poisoning and procedural complications Persistent pain	2.9% 1/34 • Number of events 1 • 2 months

Additional Information

Bernhard Dauser, MD, PhD

St John of God Hospital Vienna

Phone: +4321121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place