Hernia, InguinalNCT02415543
SIL-TEP vs TEP for Inguinal Hernia Repair in Day Surgery
A study testing SIL-TEP Inguinal Hernia Repair and TEP Inguinal Hernia Repair in people with Hernia, Inguinal, run by TAO CHEN at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- SIL-TEP Inguinal Hernia Repair and TEP Inguinal Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed of primary unilateral inguinal hernia and age between 18 and 70 ;
- Good condition of family care and observation, understand and be willing to accept day surgery mode;
- Willing to participate in this study and signed an informed consent.
Who cannot join
- Diagnosed as femoral hernia, recurrent hernia, scrotal hernia, bilateral hernia and strangulated hernia;
- Patients with severe chronic diseases or cardiopulmonary dysfunction;
- American Society of Anesthesiologists (ASA) grade III and IV level;
- Obese patients ( BMI> 30 );
- Patients with a history of lower abdominal surgery;
- prefer to a centain surgical approach.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200127
TAO CHEN, MD, +8613601779874, dr_chentao78@163.com
YUNHE ZHANG, MD, +8613917908722, zyhe31@163.com
About this study
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
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.
Read the detailed 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.
- Conditions
- Hernia, Inguinal
- Being tested
- SIL-TEP Inguinal Hernia Repair, TEP Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIL-TEP Inguinal Hernia RepairProcedure or surgery
Also called SIL-TEP repair
perform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision
TEP Inguinal Hernia RepairProcedure or surgery
Also called TEP repair
perform the multiport laparoscopic total extraperitoneal inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | Group A will undergo SIL-TEP inguinal hernia repair with a single port LESS (12 to 15 mm paraumbilical) Receives: Procedure: SIL-TEP Inguinal Hernia Repair |
| GROUP B | Active comparator | Group B will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) Receives: Procedure: TEP Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during operation
Secondary outcomes (9)
Operating time
This assess the time taken to perform the operation and is defined as time from initial skin incision to complete wound closure
Measured: during operation
interoperation complication
Assessment of interoperation procedure of the incident of spermaduct、vessel and other organ damage
Measured: during operation
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
Measured: 12、24hour and day 7 postoperation
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
Measured: 1 day postoperation
return to work or normal physical activities
Patients will be followed up and assesses how soon patients return to normal physical activities and work
Measured: 4 weeks postoperation
Cosmetic scar score
Patients will be followed up and asked to assess satisfaction of their own scars 4 weeks postoperation
Measured: 4 weeks
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
Measured: 1 week, 4 weeks after postoperation
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
Measured: 4 weeks，3 mounths and 1 year postoperation
hospitalization costs
Hospitalization costs will be assessed after operation at discharge form the hospital
Measured: 1 day postopetation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TAO CHEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TAO CHEN, RenJi Hospital
- Investigators
- JIAN WANG, MD, Study chair, Director of Biliary and Pancreatic Surgery Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415543
- Sponsor's protocol ID
- RenJi Hospital
- Status last verified
- Aug 2016
- First submitted
- 8 Apr 2015
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02415543
- Acronym / sponsor ID
- RenJi Hospital
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TAO CHENUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Procedure: SIL-TEP Inguinal Hernia RepairGroup A will undergo SIL-TEP inguinal hernia repair with a single port LESS (12 to 15 mm paraumbilical) |
| GROUP B | Active comparator | Procedure: TEP Inguinal Hernia RepairGroup B will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed of primary unilateral inguinal hernia and age between 18 and 70 ;
- Good condition of family care and observation, understand and be willing to accept day surgery mode;
- Willing to participate in this study and signed an informed consent.
Key exclusion criteria (6 listed)
- Diagnosed as femoral hernia, recurrent hernia, scrotal hernia, bilateral hernia and strangulated hernia;
- Patients with severe chronic diseases or cardiopulmonary dysfunction;
- American Society of Anesthesiologists (ASA) grade III and IV level;
- Obese patients ( BMI> 30 );
- Patients with a history of lower abdominal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIL-TEP Inguinal Hernia RepairAlso: SIL-TEP repairperform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision | Procedure or surgery | GROUP A |
| TEP Inguinal Hernia RepairAlso: TEP repairperform the multiport laparoscopic total extraperitoneal inguinal hernia repair | Procedure or surgery | GROUP B |
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.
9 secondary outcomes
Operating time
Time frame: during operation
interoperation complication
Time frame: during operation
Pain score (Visual Analog Scale) at 12、24 hour and one week after surgery
Time frame: 12、24hour and day 7 postoperation
Length of hospital stay
Time frame: 1 day postoperation
return to work or normal physical activities
Time frame: 4 weeks postoperation
Cosmetic scar score
Time frame: 4 weeks
post-operative complications including urinary retention, wound infection, wound haematoma，seroma formation, chronic pain, testicular atrophy
Time frame: 1 week, 4 weeks after postoperation
Recurrence of hernia
Time frame: 4 weeks，3 mounths and 1 year postoperation
hospitalization costs
Time frame: 1 day postopetation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIAN WANG, MD study chair
Director of Biliary and Pancreatic Surgery Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIL-TEP Inguinal Hernia Repair and TEP Inguinal Hernia Repair in people with Hernia, Inguinal, run by TAO CHEN at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAO CHEN, MD (+8613601779874 ext. 12157918664, dr_chentao78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIL-TEP Conversion to TEP / TAPP or open operation (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.