Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair (TIPP)
Primary Purpose
Inguinal Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trans-inguinal Pre-peritoneal Hernioplasty
Lichtnestein's hernioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- . Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH
Exclusion Criteria:
- Patients who were unfit for operation.
- Patients with bilateral or recurrent inguinal hernia
- Patients aged below 18 years,
- Patients undergoing emergency hernia repairs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty
Patients undergoing lichtnestein's hernioplasty
Outcomes
Primary Outcome Measures
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
post operative clinical examination for assessment of the presence and duration of chronic pain
Secondary Outcome Measures
Duration of hospital stay post operative
comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
presence of any wound complication by examining the wound
comparison between the two techniques concerning presence of any wound complications by wound examination
recurrence rate
comparison between the two techniques concerning recurrence rate of inguinal hernia
operation time
comparison between the two techniques regarding operative time
time needed for the patient to return to work
comparison between the two techniques regarding needed time to return to work
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03438786
Brief Title
Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
Acronym
TIPP
Official Title
Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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:
Patients who were unfit for operation.
Patients with bilateral or recurrent inguinal hernia
Patients aged below 18 years,
Patients undergoing emergency hernia repairs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients will be randomized into two groups according to the surgical technique performed as follows :-
Group A: Patients undergoing TIPP hernioplasty
Group B: Patients undergoing lichtnestein's technique hernioplasty
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty
Arm Title
group B
Arm Type
Experimental
Arm Description
Patients undergoing lichtnestein's hernioplasty
Intervention Type
Procedure
Intervention Name(s)
Trans-inguinal Pre-peritoneal Hernioplasty
Other Intervention Name(s)
TIPP Technique
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Lichtnestein's hernioplasty
Intervention Description
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
Primary Outcome Measure Information:
Title
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain
Description
post operative clinical examination for assessment of the presence and duration of chronic pain
Time Frame
visits will be within 6 months post operative
Secondary Outcome Measure Information:
Title
Duration of hospital stay post operative
Description
comparison between the two techniques concerning Duration of hospital stay post operation after each procedure
Time Frame
first week post operative
Title
presence of any wound complication by examining the wound
Description
comparison between the two techniques concerning presence of any wound complications by wound examination
Time Frame
first 2 weeks post operative
Title
recurrence rate
Description
comparison between the two techniques concerning recurrence rate of inguinal hernia
Time Frame
6 to 12 month post operative
Title
operation time
Description
comparison between the two techniques regarding operative time
Time Frame
intra-operative
Title
time needed for the patient to return to work
Description
comparison between the two techniques regarding needed time to return to work
Time Frame
1 month post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH
Exclusion Criteria:
Patients who were unfit for operation.
Patients with bilateral or recurrent inguinal hernia
Patients aged below 18 years,
Patients undergoing emergency hernia repairs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamad hamdy, MBBS
Phone
01028086209
Email
mohamdy.mh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
faculty of medicine - assiut university faculty of medicine - assiut university
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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
Citations:
PubMed Identifier
11432408
Citation
Cheek CM, Black NA, Devlin HB, Kingsnorth AN, Taylor RS, Watkin DF. Groin hernia surgery: a systematic review. Ann R Coll Surg Engl. 1998;80 Suppl 1:S1-80.
Results Reference
background
PubMed Identifier
14735339
Citation
Heikkinen T, Bringman S, Ohtonen P, Kunelius P, Haukipuro K, Hulkko A. Five-year outcome of laparoscopic and Lichtenstein hernioplasties. Surg Endosc. 2004 Mar;18(3):518-22. doi: 10.1007/s00464-003-9119-4. Epub 2004 Jan 23.
Results Reference
background
PubMed Identifier
16329082
Citation
Vironen J, Nieminen J, Eklund A, Paavolainen P. Randomized clinical trial of Lichtenstein patch or Prolene Hernia System for inguinal hernia repair. Br J Surg. 2006 Jan;93(1):33-9. doi: 10.1002/bjs.5235.
Results Reference
background
PubMed Identifier
8251018
Citation
Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30. Erratum In: Surg Gynecol Obstet 1993 Nov;177(5):528.
Results Reference
background
PubMed Identifier
15610887
Citation
Awad SS, Fagan SP. Current approaches to inguinal hernia repair. Am J Surg. 2004 Dec;188(6A Suppl):9S-16S. doi: 10.1016/j.amjsurg.2004.09.007.
Results Reference
background
PubMed Identifier
21656724
Citation
Chung L, Norrie J, O'Dwyer PJ. Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial. Br J Surg. 2011 Apr;98(4):596-9. doi: 10.1002/bjs.7355. Epub 2010 Nov 30.
Results Reference
background
PubMed Identifier
19636493
Citation
Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
Results Reference
background
Links:
URL
https://emedicine.medscape.com/article/1534281-overview
Description
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URL
https://emedicine.medscape.com/article/1534281-technique#c2
Description
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Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair
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