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

NCT03438786 | Unknown

• 1 other identifier: inguinal hernia
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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

  visits will be within 6 months post operative

Secondary Outcomes (5)

• Duration of hospital stay post operative

  first week post operative

• presence of any wound complication by examining the wound

  first 2 weeks post operative

• recurrence rate

  6 to 12 month post operative

• operation time

  intra-operative

• time needed for the patient to return to work

  1 month post operative

Study Arms (2)

group A

EXPERIMENTAL

Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty

Procedure: Trans-inguinal Pre-peritoneal Hernioplasty

group B

EXPERIMENTAL

Patients undergoing lichtnestein's hernioplasty

Procedure: Lichtnestein's hernioplasty

Interventions

Trans-inguinal Pre-peritoneal Hernioplasty PROCEDURE

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

Also known as: TIPP Technique

group A

Lichtnestein's hernioplasty PROCEDURE

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

group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 11432408 BACKGROUND

• 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.

  PMID: 14735339 BACKGROUND

• 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.

  PMID: 16329082 BACKGROUND

• Gilbert AI, Felton LL. Infection in inguinal hernia repair considering biomaterials and antibiotics. Surg Gynecol Obstet. 1993 Aug;177(2):126-30.

  PMID: 8251018 BACKGROUND

• 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.

  PMID: 15610887 BACKGROUND

• 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.

  PMID: 21656724 BACKGROUND

• 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.

  PMID: 19636493 BACKGROUND

Related Links

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MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mohamad hamdy, MBBS

CONTACT

01028086209; mohamdy.mh@gmail.com

faculty of medicine - assiut university faculty of medicine - assiut university

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at General surgery department

Model Details: 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

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 20, 2018
• Study Start: March 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: February 20, 2018

Record last verified: 2018-02