Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair (TIPP)

February 17, 2018 updated by: Mohamad Hamdy, Assiut University

Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair

Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin pain following LR.

Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position .

Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020

Methodology:

Patients will be classified into two groups according to the surgical procedure performed as follows:

  • Group A: Patients undergoing TIPP hernioplasty
  • Group B: Patients undergoing lichtnestein's technique hernioplasty

Sample size:15 patients for each group.

D) Exclusion criteria:

  1. Patients who were unfit for operation.
  2. Patients with bilateral or recurrent inguinal hernia
  3. Patients aged below 18 years,
  4. Patients undergoing emergency hernia repairs

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • . Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH

Exclusion Criteria:

  1. Patients who were unfit for operation.
  2. Patients with bilateral or recurrent inguinal hernia
  3. Patients aged below 18 years,
  4. Patients undergoing emergency hernia repairs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty
Procedure: Trans-inguinal Pre-peritoneal Hernioplasty

patients were catheterised pre-operatively, to prevent any injury to the bladder and aid in preperitoneal dissection. The catheter was removed after 48 hours post-operatively.

Incision of TIPP is same as that of Lichtenstein technique . After dissection of the sac, the transversalis is fascia is incised to enter the preperitoneal space. The preperitoneal space is developed by dissection with index finger. The space extends from rectus muscle medially, arcuate line cranially, a little beyond the anterior superior iliac spine over the psoas muscle laterally and the lilipubic tract caudally. A 15 cm x 15 cm polypropylene mesh, cut into dimension 15 cm x 12 cm, the inferior medial angle of the mesh is trimmed in a semicircular fashion to prevent trauma to the bladder neck. The mesh is placed in the preperitoneal space and anchored to the Cooper's ligament with a single 2-0 interrupted prolene suture

Other Names:
  • TIPP Technique
Experimental: group B
Patients undergoing lichtnestein's hernioplasty
Procedure: Lichtnestein's hernioplasty
incision 1 cm above and parallel to inguinal ligament,Opening subcutaneous fat ,Opening Scarpa fascia to external oblique aponeurosis ,visualization of external ring and lower border of the inguinal ligament,Opening deep fascia of the thigh,checking for a femoral hernia ,Division of external oblique aponeurosis from external ring laterally for 5 cm, safeguarding ilioinguinal nerve ,Mobilization of superior and inferior flaps of external oblique aponeurosis exposing underlying structures ,Mobilization of spermatic cord along with the cremaster, including (ilioinguinal ,genitofemoral) nerves, and spermatic vessels; all of these structures may be encircled in a tape ,Opening of the coverings of spermatic cord, identification and isolation of the hernia sac ,Inversion, division, resection, or ligation of the sac ,Placement and fixation of mesh to edges of the defect or weakness in the posterior wall of inguinal canal creating artificial internal ring,Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
Time Frame: visits will be within 6 months post operative
post operative clinical examination for assessment of the presence and duration of chronic pain
visits will be within 6 months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay post operative
Time Frame: first week post operative
comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
first week post operative
presence of any wound complication by examining the wound
Time Frame: first 2 weeks post operative
comparison between the two techniques concerning presence of any wound complications by wound examination
first 2 weeks post operative
recurrence rate
Time Frame: 6 to 12 month post operative
comparison between the two techniques concerning recurrence rate of inguinal hernia
6 to 12 month post operative
operation time
Time Frame: intra-operative
comparison between the two techniques regarding operative time
intra-operative
time needed for the patient to return to work
Time Frame: 1 month post operative
comparison between the two techniques regarding needed time to return to work
1 month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

February 17, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 17, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inguinal hernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Clinical examination will be undertaken immediately post-operative looking for any wound complication or scrotal collection .

Clinical examination will be undertaken at 1 , 3 ,6 months post-operative looking for :-

  • Wound complication
  • Scrotal collection
  • Chronic Pain
  • Recurrence

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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