Laparoscopic TEP (Total Extra-peritoneal) Repair Vs Open PHS (Prolene Hernia System)

NCT03842852 | Completed DMC

• 1 other identifier: 02-19
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women. Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention. The most common hernia in both sexes is the indirect inguinal hernia. The male-to-female ratio is 9:1 for inguinal hernias and 1:3 for femoral hernias. Inguinal hernia repair is one of the most common operations undertaken in routine surgical practice. Since the introduction of the Bassini method in 1887, more than 70 types of pure tissue repair have been reported in the surgical literature. Throughout the years, attention was paid to the recurrences that occur after the use of tissue approximation technique, in the literature it has been reported that they occur in up to 34% of cases, being that the actual incidence of recurrences it is underreported, therefore, the repair of the hernia with approximation of tissue has practically been abandoned. The concept of tension free repair for hernias was introduced by Lichtenstein who explain that the prime etiologic factor behind most herniorrhaphy failures is the suturing together, under tension, of structures that are not normally in apposition. The technique of the hernioplasty with the use of mesh was not widely accepted at first, the expansion of the use of mesh expanded for years. The use of mesh increased from 7 per cent of all operations in 1992 to 51 per cent in 1996. Currently, groin hernia treatment is not standardized but, today, tension free mesh repair technique is regarded as gold standard. Based in the Stoppa technique, the laparoscopic hernia repair was developed in 1991. The most common laparoscopic techniques for inguinal hernia repair are transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair. The use of the laparoscopic technique was progressively increasing based on the advantages of minimal invasive procedures, but since the publication of Neumayer in 2004, where he reports a recurrent incidence in laparoscopic hernia of 10.1 % compared with 4% for open surgery, the use of laparoscopic repair declines considerably. Surgeons remain divided on the best technique for inguinal hernia repair: while more than half never perform laparoscopic inguinal hernia repair, today the laparoscopic technique for hernia repair is used in 28% of cases, of which 25% is used the TEP approach and is considered the best approach for bilateral inguinal hernia repair (17). Advantages and disadvantages of TEP are: faster return to usual activities, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries (18). In 1999, Gilbert published the use of bilayer patch device, known as prolene ® hernia system (Ethicon; Somerville, NJ, USA) (PHS) to repair inguinal hernia. The unique feature of this polypropylene mesh device is that it has attached the component, its underlay patch provides a pre-peritoneal repair, a connector that has the desirable attributes of a plug and an onlay patch covers the back wall. In the literature, better results have been reported for PHS repair than for Lichtenstein repair. The advantages of the anterior repair of inguinal hernias are: low operative costs, short learning curve, reproducible results at all levels and the possibility of the use of local anesthesia. The objective of this study is to compare the results of laparoscopic totally extra-peritoneal repair (LTEPR) with open prolene hernia system repair (OPHSR) retrospectively.

Conditions

Inguinal Hernia

Keywords

inguinal hernia; laparoscopy reapir; open repair

Outcome Measures

Primary Outcomes (2)

• Pain scale

  the patients were asked to classified their pair after surgery in visual analog scale from 0 to 10, being 0: no pain and 10 severe pain. (0: no pain, 1 to 3: mild pain, 4 to 6: moderate pain, and 7 to 10 severe pain.

  60 months

• complication after surgery

  Complications were recorded from the records: type and number. Each type of complication is presented in a number of occurrences and calculates the percent of occurrence.

  60 months

Secondary Outcomes (3)

• Diary activity performance

  60 months

• Scar satisfaction

  60 months

• sexual function

  60 months

Study Arms (2)

LTEPR

Patients who underwent inguinal hernia repair laparoscopic extra-peritoneal repair under general anesthesia.

Procedure: Inguinal hernia repair

OPHSR

Patients that underwent inguinal hernia repair open using prolene hernia system mesh under general or regional anesthesia.

Procedure: Inguinal hernia repair

Interventions

Inguinal hernia repair PROCEDURE

The grupo one underwent open repair and laparoscopic repair

LTEPR; OPHSR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that underwent laparoscopic (TEP) repair with bilateral or recurrent hernia or open PHS repair with unilateral hernia or contraindication for general anesthesia .

You may qualify if:

• For laparoscopic repair: bilateral inguinal hernia or recurrent hernia For open repair: Patients with unilateral inguinal hernia More than 18 years old. Both sexes

You may not qualify if:

• Patient under 18 years old Patients who cannot sign the informed consent.

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

ASSUTAMC

Tel Aviv, 69710, Israel

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Officials

• sergio Susmallian, MD

  Assuta Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of general surgery

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 15, 2019
• Study Start: January 1, 2003
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 60 months

Locations

IL (1)