Trial Outcomes & Findings for Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair (NCT NCT01117337)

Results Overview

Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

104 participants

Primary outcome timeframe

1 year

Results posted on

2010-08-31

Participant Flow

Between September to December 2008, 120 patients with inguinal hernia presented to randomization at Moulana Hospital, Perianthalmanna, Kerala, India.

15 patients didn't meet inclusion criteria and one patient didn't give consent. 104 patients were randomized to mesh fixation (52 patients) and mesh non-fixation (52 patients). One month and one year follow-up was completed in 100 patients. The follow-up ranged from 15-19 months with a median of 16.2 months.

Participant milestones

Participant milestones
Measure	Mesh Fixation Group Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group The patients in whom the mesh was not fixed by any means
Overall Study STARTED	52	52
Overall Study Underwent Surgery	52	52
Overall Study COMPLETED	48	52
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mesh Fixation Group Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group The patients in whom the mesh was not fixed by any means
Overall Study Lost to Follow-up	4	0

Baseline Characteristics

Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mesh Fixation Group n=52 Participants Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group n=52 Participants The patients in whom the mesh was not fixed by any means	Total n=104 Participants Total of all reporting groups
Age Continuous	47.2 years STANDARD_DEVIATION 12.9 • n=5 Participants	51.9 years STANDARD_DEVIATION 16.8 • n=7 Participants	49.6 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.

Outcome measures

Outcome measures
Measure	Mesh Fixation Group n=48 Participants Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group n=52 Participants The patients in whom the mesh was not fixed by any means
Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.	0 Participant	0 Participant

PRIMARY outcome

Timeframe: 1 month

To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.

Outcome measures

Outcome measures
Measure	Mesh Fixation Group n=48 Participants Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group n=52 Participants The patients in whom the mesh was not fixed by any means
Proportion of Patients Having Pain in the Post Operative Period	3 Participant	8 Participant

SECONDARY outcome

Timeframe: One year

A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.

Outcome measures

Outcome measures
Measure	Mesh Fixation Group n=48 Participants Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers	Mesh Non Fixation Group n=52 Participants The patients in whom the mesh was not fixed by any means
Seroma Formation	5 Participant	8 Participant

Adverse Events

Mesh Fixation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mesh Non Fixation Group

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

Mohamed Ismail, Chief Consultant, Moulana Hospital, Perianthalmanna

Moulana Hospital

Phone: 0091-9447128511

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place