Clinical Trial: SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Trial of Comparing Single Incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair With Traditional Laparoscopic

Brief Summary:

This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve the surgical-related technical details and the device design.

In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in the investigators country.


Detailed Summary:

This is a prospective, randomized，controlled trail. It compared Single Incisional Laparoscopic Total Extraperitonea(SIL-TEP) with traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in condition of day surgery.

Laparoscopic hernia repair technique including two tyes, TEP and TAPP, which were recognized as mordern minimally invasive technique. Laparoscopic hernia repair were recommended by the Association of Surgeons of Great Britain and Ireland (ASGBI) and European Hernia Society Guideline (EHS) as the first choice for primary inguinal hernia. Compared with TAPP, TEP was performed much more frequently for its advantages of avoiding abdominal visceral injury.

Traditional TEP hernia repair involves 3-port insertions: one incision of 2cm in para-umbilical region for the camera and two smaller incisions of 5mm each in the midline for the surgical instruments. Some surgeons think the second and third ports could led to bowel and bladder injury. Early literatures showed that bowel injuries and bladder injuries were observed in TAPP or TEP hernia repair.

Since 2009, Cugura JF and Filipovic-Cugura J led their teams for a preliminary exploration of SIL-TEP. Later, several cases were reported about this surgical technique globally. Since then, a number of retrospective studies about the comparation of SIL-TEP and traditional TEP were carried. Yang GP et al found that SIL-TEP had a longer operation time than traditional TEP, but in terms of postoperative complications and incision aesthetics. Tu Wenbin et al thought that SIL-TEP was effective and also had advantages in postoperative pain, postoperative complications and time in hospital. Several other reports also had similiar opnions.

However, randomized
Sponsor: TAO CHEN

Current Primary Outcome: SIL-TEP Conversion to TEP / TAPP or open operation [ Time Frame: during operation ]

This refers to whether any SIL-TEP procedure needs to be converted to TEP/TAPP or open procedure. This is quite a normal process as a proportion of multiport procedures are converted to open procedures for safety reasons.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Operating time [ Time Frame: during operation ]
    This assess the time taken to perform the operation and is defined as time from initial skin incision to complete wound closure
  • interoperation complication [ Time Frame: during operation ]
    Assessment of interoperation procedure of the incident of spermaduct、vessel and other organ damage
  • Pain score (Visual Analog Scale) at 12、24 hour and one week after surgery [ Time Frame: 12、24hour and day 7 postoperation ]
    Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and any painkiller consumption will be recorded
  • Length of hospital stay [ Time Frame: 1 day postoperation ]
    This assess how long patients stay in hospital and whether it is a day surgery or they need to extend time stay in hospital
  • return to work or normal physical activities [ Time Frame: 4 weeks postoperation ]
    Patients will be followed up and assesses how soon patients return to normal physical activities and work
  • Cosmetic scar score [ Time Frame: 4 weeks ]
    Patients will be followed up and asked to assess satisfaction of their own scars 4 weeks postoperation
  • post-operative complications including urinary retention, wound infection, wound haematoma，seroma formation, chronic pain, testicular atrophy [ Time Frame: 1 week, 4 weeks after postoperation ]
    Patients will be followed up and assessed at 1 week, 4 weeks after surgery to assess for any post-operative complications associated with hernia surgery as enumerated above
  • Recurrence of hernia [ Time Frame: 4 weeks，3 mounths and 1 year postoperation ]
    Patients will be followed up and assessed at 4 weeks，3 mounths and one year after surgery to detect the presence of recurrence of hernia
  • hospitalization costs [ Time Frame: 1 day postopetation ]
    Hospitalization costs will be assessed after operation at discharge form the hospital


Original Secondary Outcome: Same as current

Information By: RenJi Hospital

Dates:
Date Received: April 8, 2015
Date Started: March 2016
Date Completion: December 2018
Last Updated: August 25, 2016
Last Verified: August 2016