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
|
|
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
|
|
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 ï¬rst 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 ï¬rst 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 |