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CTRI Number  CTRI/2018/11/016348 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 14/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effectiveness and safety of laparoscopic method of inguinal hernia surgeries. 
Scientific Title of Study   A Randomized control trial to evaluate efficacy, safety of TAPP versus TEP in unilateral,uncomplicated inguinal hernia undergoing elective laparoscopic inguinal Hernia surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krashan Kant Premi 
Designation  Post Graduate Resident,Department of General Surgery 
Affiliation  AIIMS,Jodhpur 
Address  Room no 403,Type 1 quarters,AIIMS Jodhpur
Room no 403,Type 1 quarters,AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  7740843481  
Fax  7740843481  
Email  krashankantpremi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Krashan Kant Premi 
Designation  Post Graduate Resident,Department of General Surgery 
Affiliation  AIIMS,Jodhpur 
Address  room no 403,type 1 quarters,AIIMS Jodhpur
room no 403,type 1 quarters,AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  7740843481  
Fax  7740843481  
Email  krashankantpremi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Krashan Kant Premi 
Designation  Post Graduate Resident,Department of General Surgery 
Affiliation  AIIMS,Jodhpur 
Address  room no 403,type 1 quarters,AIIMS Jodhpur
room no 403,type 1 quarters,AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  7740843481  
Fax    
Email  krashankantpremi@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Hospital,Basni Phase 2, Jodhpur pin code 342005 
 
Primary Sponsor  
Name  AIIMSJodhpur 
Address  AIIMS Jodhpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mahaveer Singh Rodha  AIIMS Hospital Jodhpur  Room no 403,type 1 quarters,general surgery
Jodhpur
RAJASTHAN 
8003996885

msrodha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TAPP  in this group After GA the pneumo-peritoneum was created through supra umbilical port. After achieving intra-abdominal pressure 14 mm of hg, working port are placed. One 10 mm camera port at supra umbilical region rest two 5 mm port at mid clavicular line at level of umbilicus. After inspection of abdomen, peritoneal incision 5 cm cranial to inguinal defect is given. Pre-peritoneum space is created. cooper ligament is identified medially. The medial limit of dissection is opposite side of cooper ligament. Cord structures are identified and hernia sac is separated from cord structures. The lateral limit of dissection is counter part of anterior superior iliac spine(ASIS). The lower limit of dissection is vas deferens turn to medially or mid of psoas muscle. After proper dissection a 15x12 cm poly propylene mesh is placed in pre-peritoneum space. The peritoneum sutured with absorbable suture. Port site is closed with proper suture. 
Intervention  TEP  In this group after GA, A 10mm port just below the umbilicus was made for the 10-mm 30o telescope. The rectus muscle was retracted laterally after incising the anterior rectus sheath and a blunt dissection was done using a peanut for the 10–12-mm port and the 10-mm 30o telescope to create preperitoneal space. Further dissection proceeded with the telescope until the pubic symphysis was seen in the midline. Two 5-mm ports were inserted, one just above the pubic symphysis and the other in the midline between umbilical port and pubic symphysis. The pubic symphysis is the first anatomical landmark recognized. The dissection proceeded laterally, identifying the inferior epigastric vessels, and further laterally up to correspond to the anterior superior iliac spine. The peritoneal flap was then raised inferiorly exposing the deep ring, triangle of doom, psoas major muscle, and the nerves. The peritoneum was teased down as low as possible. The femoral/direct hernia was easily reduced before identifying the inferior epigastric vessels. The indirect hernia sac was reduced completely if the sac was incomplete; the hernia sac was divided after ligation if it was a complete hernia. A 15x 12 cm polypropylene mesh is used. The mesh was unrolled and left in the preperitoneal space, adequately covering the deep inguinal ring, Hasselbach’s triangle, and femoral hernia sites. The pneumoperitoneum was released. The fascia of the umbilical port was closed using Vicryl suture. The port sites were closed. Skin is sutured with staplers. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  1.A patient of age more than 18 years.
2.uncomplicated unilateral inguinal hernia undergoing elective laparoscopic hernia repair(TEP or TAPP) 
 
ExclusionCriteria 
Details  1.patient not willing to participates in study.
2.complicated inguinal hernia.
3.recurrent inguinal hernia.
4.patient is not fit for GA.
5.coagulopathy.
6.B/L inguinal hernia.
7.female inguinal hernia.
8.previous lower abdominal surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare post operative pain   immediate post op,6 hours,day 1, day 2, day 7,3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare Seroma,hematoma,infection rate and retention of urine.
2.To compare length of hospital stay.
3.Resumption of early routine work.
4.To compare operative time.
5.Intraoperative complications like bowel or vascular injury. 
Immediate post op,6 hours,day 1,day 2,day 7,3rd month 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 Group A (TAPP)

After GA the pneumo-peritoneum was created through supra umbilical port. After achieving intra-abdominal pressure 14 mm of hg, working port are placed. One 10 mm camera port at supra umbilical region rest two 5 mm port at mid clavicular line at level of umbilicus. After inspection of abdomen, peritoneal incision 5 cm cranial to inguinal defect is given. Pre-peritoneum space is created. cooper ligament is identified medially. The medial limit of dissection is opposite side of cooper ligament. Cord structures are identified and hernia sac is separated from cord structures. The lateral limit of dissection is counter part of anterior superior iliac spine(ASIS). The lower limit of dissection is vas deferens turn to medially or mid of psoas muscle. After proper dissection a 15x12 cm poly propylene mesh is placed in pre-peritoneum space. The peritoneum sutured with absorbable suture. Port site is closed with proper suture.

Group B (TEP)

After GA, A 10mm port just below the umbilicus was made for the 10-mm 30o telescope. The rectus muscle was retracted laterally after incising the anterior rectus sheath and a blunt dissection was done using a peanut for the 10–12-mm port and the 10-mm 30o telescope to create preperitoneal space. Further dissection proceeded with the telescope until the pubic symphysis was seen in the midline. Two 5-mm ports were inserted, one just above the pubic symphysis and the other in the midline between umbilical port and pubic symphysis. The pubic symphysis is the first anatomical landmark recognized. The dissection proceeded laterally, identifying the inferior epigastric vessels, and further laterally up to correspond to the anterior superior iliac spine. The peritoneal flap was then raised inferiorly exposing the deep ring, triangle of doom, psoas major muscle, and the nerves. The peritoneum was teased down as low as possible. The femoral/direct hernia was easily reduced before identifying the inferior epigastric vessels. The indirect hernia sac was reduced completely if the sac was incomplete; the hernia sac was divided after ligation if it was a complete hernia. A 15x 12 cm polypropylene mesh is used. The mesh was unrolled and left in the preperitoneal space, adequately covering the deep inguinal ring, Hasselbach’s triangle, and femoral hernia sites. The pneumoperitoneum was released. The fascia of the umbilical port was closed using Vicryl suture. The port sites were closed. Skin is sutured with staplers.

We will measure any intraoperative complication like bowel or vascular injury in both group and record accordingly.

Conversion will be noted in both group if it is required. The reason of conversion will also be noted

 
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