SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-07-31

Brief Summary

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This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia using a mesh carried out with only 1 port (hole) results in the reduction of post- operative pain and use of painkillers, shorter hospital stay and lesser complications than that carried out using conventional 3 ports.

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Detailed Description

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100 patients undergoing laparoscopic TEP ( Total extraperitoneal repair) inguinal hernia repair under general anaesthesia will be randomized into 2 groups by the closed envelope method. In case of difficulty in Single port TEP inguinal hernia repair, the procedure will be converted to conventional 3 port repair for patient safety.

2 groups of participants: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical).

Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. The blind will only be lifted after pain score and area of pain has been recorded before discharge.

Conditions

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Primary Unilateral Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group A: Standard TEP

Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Group Type ACTIVE_COMPARATOR

Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )

Intervention Type PROCEDURE

laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Group B: LESS Port

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical).

Group Type ACTIVE_COMPARATOR

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port

Intervention Type PROCEDURE

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).

Interventions

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Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )

laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Intervention Type PROCEDURE

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age: 21- 80 yrs

* Informed consent
* Diagnosis of Hernia
* ASA I and II
* BMI\<25.

Exclusion Criteria

Bleeding disorders

* Age below 21
* Strangulated Hernia
* BMI \> 30
* Incarcerated and obstructed hernia
* Recurrent hernia
* Bilateral hernia
* Previous LSCS
* Previous lower abdominal surgery

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No