Trial Outcomes & Findings for Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair (NCT NCT00815698)

Results Overview

The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

334 participants

Primary outcome timeframe

12 months after surgery

Results posted on

2016-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	no Suture self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh	Suture Suture for mesh fixation suture: suture for mesh fixation
Overall Study STARTED	163	171
Overall Study COMPLETED	163	171
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	no Suture n=163 Participants self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh	Suture n=171 Participants Suture for mesh fixation suture: suture for mesh fixation	Total n=334 Participants Total of all reporting groups
Age, Continuous	56.8 years n=5 Participants	59.9 years n=7 Participants	58.0 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	171 Participants n=7 Participants	334 Participants n=5 Participants
Region of Enrollment Denmark	163 participants n=5 Participants	171 participants n=7 Participants	334 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after surgery

The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.

Outcome measures

Outcome measures
Measure	no Suture n=163 Participants self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh	Suture n=171 Participants Suture for mesh fixation suture: suture for mesh fixation
Pain, Numbness and Discomfort in the Groin	28 participants	34 participants

SECONDARY outcome

Timeframe: 12 months after surgery

recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.

Outcome measures

Outcome measures
Measure	no Suture n=163 Participants self-adhesive mesh, i.e. no suture for mesh fixation no suture: no suture for mesh fixation, because we use a self-adhesive mesh	Suture n=171 Participants Suture for mesh fixation suture: suture for mesh fixation
Recurrence	2 participants	2 participants

Adverse Events

no Suture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Suture

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

Jacob Rosenberg

Herlev Hospital, dept. of Surgery

Phone: +45 26237323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place