| CTRI Number |
CTRI/2024/11/076172 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| 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
|
Comparision between two hernia repair techniques ( Lichtenstein mesh repair and Modified anterior preperitoneal mesh repair ) |
|
Scientific Title of Study
|
Modified anterior preperitoneal mesh repair versus Lichtenstein mesh repair for inguinal hernias – A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omkumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Rohailkhand medical college and hospital |
| Address |
Room number 2072 ,Department of general surgery Rohailkhand medical college and hospital, Pilibhit bypass road, Bareilly, Uttarpradesh 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9457514028 |
| Fax |
|
| Email |
dr.omkumarsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omkumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Rohailkhand medical college and hospital |
| Address |
Room number 2072 ,Department of general surgery Rohailkhand medical college and hospital, Pilibhit bypass road, Bareilly, Uttarpradesh 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9457514028 |
| Fax |
|
| Email |
dr.omkumarsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Inzamam Ul Haque |
| Designation |
Junior Resident |
| Affiliation |
Rohailkhand medical college and hospital |
| Address |
Room number 2072 ,Department of general surgery Rohailkhand medical college and hospital, Pilibhit bypass road, Bareilly, Uttarpradesh 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997197904 |
| Fax |
|
| Email |
inzamam1097@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery Rohailkhand medical college and hospital, Pilibhit bypass road, Bareilly, Uttarpradesh 243006 |
|
|
Primary Sponsor
|
| Name |
ROHAILKAHND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room number 2072 ,Department of general surgery Rohailkhand medical college and hospital, Pilibhit bypass road, Bareilly, Uttarpradesh 243006 |
| Type of Sponsor |
Private 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 |
| Dr Omkumar Sharma |
Rohailkhand medical college and hospitalOF GENERAL SURGERY |
Room number 2072 ,Department of general surgery
Bareilly
UTTAR PRADESH |
9457514028
dr.omkumarsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,RMCH , Bareilly ,U.P |
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 |
Lichtenstein mesh repair |
In Lichtenstein repair surgery will be initiated by giving inguinal skin incision starting medially at pubic tubercle and laterally extending beyond the deep inguinal ring 2cm above and parallel to inguinal ligament. Then exposure of inguinal canal will be done, the external oblique aponeurosis will be exposed deep to the subcutaneous tissue.After this dissection of hernial sac will be done. The spermatic cord along with hernial sac will be dissected in between fingers using a gauge piece and lifted up from fascia transversalis. Furthermore herniotomy will be done in which hernial sac will twisted and the neck of sac will be transfixed and the distal sac is excised. Then reinforcement of posterior wall is done by placement of polypropylene mesh (i.e. Prolus lite) of dimension 15x7.5cm will be done. Mesh will be medially sutured to lateral border of rectus sheath, and will be fixed above to the conjoint tendon using number 1 propylene suture. Then closure of external oblique aponeurosis followed by closure of subcutaneous tissue and skin will be done.The time taken in the surgery and complications will be noted along with post operative complications and recurrence in 1 year of the study
|
| Intervention |
Modified anterior preperitoneal mesh repair |
Modified anterior preperitoneal mesh repair. Small oblique incision shall be given starting from DIR (Deep inguinal ring) and directed towards pubic tubercle. Through DIR access to preperitoneal space will be taken to limit the dissection of sac proximally in inguinal canal. The entry to preperitoneal space is initiated by elevating the medial crus of the DIR and also retracting it medially, this is done at the level of inferior epigastric vessel to make sure the entry is correct inside avascular preperitoneal space. Then forefinger is inserted in the interim the sac and the vas deference.An important thing to note is that vessels of sub inguinal Retzius and Bogoros space lie in between 2 layers of transversalis fascia anteriorly. Further the medial crus of DIR is lifted to mark that the entry of finger is in avascular preperitoneal space. Blunt dissection with finger is preferred in this area as it hardly ever cause bleeding. Then a light weight, knitted, monofilament polypropylene mesh ie (Prolus lite) of dimension 10x15cm will be placed over inguinal canal with overlap of on all side. To ensure adequate and accurate mesh placement an unfurrowed mesh will be rolled up in a Cigarette like fashion and further will be placed through DIR below the surface of abdominal wall (anterior), the mesh will be placed in such a manner that suturing of mesh is not required. After the placement of mesh the closure is ensured by removing the retractor so that the deep inguinal ring returns back to its original form and position. Furthermore, interrupted 2-0 sutures (polypropylene) will be done medially to cord (Lytle’s Repair).
These sutures aid in approximating enlarged DIR because of enlarged hernia and keeping obliquity of canal by compressing cord laterally. Also in direct inguinal hernia (DIH) of large size , in case if the wall of posterior inguinal hernia feeble and unfastened few interrupted, reinforcing double breasting suturing can also be done.
the time taken in the surgery and complications will be noted along with post operative complications and recurrence in 1 year of the study
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients having inguinal hernia |
|
| ExclusionCriteria |
| Details |
1.Patients having ASA Grade 3and 4
2.Recurrent hernia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Operative time taken in each procedure
2.Intra operative complications
3.Postoperative pain
4.Hospital stay
5.Postoperative complications
6.Recurrence in duration of study |
During surgery any kind of complications occuring will be noted along with the time taken. A note will be taken of post operative complication, hospital stay, post operative pain and recurrance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for hernia recurrence during study period |
Post surgery timely follow up will be done to note the hernia recurrence |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A hernia is the protrusion of an organ or fatty tissue through the wall containing it, often due to weak muscle or connective tissue. Inguinal hernias are common, especially in males, often resulting from the descent of the testis during birth. This study aims to compare two surgical techniques for inguinal hernia repair: Modified Anterior Preperitoneal (mAPP) mesh repair and Lichtenstein mesh repair. Conducted as a randomized controlled trial at Rohilkhand Medical College, the study will include adult patients with inguinal hernias, excluding those with severe health issues or recurrent hernias The study will assess operative time, complications, postoperative pain, hospital stay, and recurrence rates over one year at Rohilkhand Medical College, ensuring ethical standards, including informed consent and data protection. Participants will be randomly assigned to either mAPP or Lichtenstein repair. The mAPP technique involves placing a polypropylene mesh in the preperitoneal space, while the Lichtenstein method involves exposing and reinforcing the inguinal canal with mesh. With a sample size of 32 in each group, data will be analyzed using statistical methods, with a significance level set at p < 0.05. This research seeks to evaluate the effectiveness of mAPP as an alternative to Lichtenstein repair. Both surgical techniques will be assessed for their effectiveness and associated complications. |