SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery

Hernia, Inguinal Clinical Trial

Official title:

A Prospective, Randomized, Controlled Trial of Comparing Single Incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair With Traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in Day Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415543
• Other study ID #: RenJi Hospital
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2015
• Last updated: August 25, 2016
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: RenJi Hospital
• Contact: TAO CHEN, MD
• Phone: +8613601779874
• Email: dr_chentao78[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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 controlled trial related to this suject is quite limited. Our study aim to compare the efficacy and safety of SIL-TEP and traditional TEP surgery with a RCT design and also aim to improve the surgical-related technical details and the device design. Our 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 our country.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosed of primary unilateral inguinal hernia and age between 18 and 70 ;

2. Good condition of family care and observation, understand and be willing to accept day surgery mode;

3. Willing to participate in this study and signed an informed consent.

Exclusion Criteria:

1. Diagnosed as femoral hernia, recurrent hernia, scrotal hernia, bilateral hernia and strangulated hernia;

2. Patients with severe chronic diseases or cardiopulmonary dysfunction;

3. American Society of Anesthesiologists (ASA) grade III and IV level;

4. Obese patients ( BMI> 30 );

5. Patients with a history of lower abdominal surgery;

6. prefer to a centain surgical approach.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• SIL-TEP Inguinal Hernia Repair
perform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision
• TEP Inguinal Hernia Repair
perform the multiport laparoscopic total extraperitoneal inguinal hernia repair

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
TAO CHEN

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIL-TEP Conversion to TEP / TAPP or open 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.	during operation	Yes
Secondary	Operating time	This assess the time taken to perform the operation and is defined as time from initial skin incision to complete wound closure	during operation	Yes
Secondary	interoperation complication	Assessment of interoperation procedure of the incident of spermaduct?vessel and other organ damage	during operation	Yes
Secondary	Pain score (Visual Analog Scale) at 12?24 hour and one week after surgery	Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and any painkiller consumption will be recorded	12?24hour and day 7 postoperation	Yes
Secondary	Length of hospital stay	This assess how long patients stay in hospital and whether it is a day surgery or they need to extend time stay in hospital	1 day postoperation	Yes
Secondary	return to work or normal physical activities	Patients will be followed up and assesses how soon patients return to normal physical activities and work	4 weeks postoperation	Yes
Secondary	Cosmetic scar score	Patients will be followed up and asked to assess satisfaction of their own scars 4 weeks postoperation	4 weeks	Yes
Secondary	post-operative complications including urinary retention, wound infection, wound haematoma,seroma formation, chronic pain, testicular atrophy	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	1 week, 4 weeks after postoperation	Yes
Secondary	Recurrence of hernia	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	4 weeks,3 mounths and 1 year postoperation	Yes
Secondary	hospitalization costs	Hospitalization costs will be assessed after operation at discharge form the hospital	1 day postopetation	Yes