Inguinal Hernioplasty
Conditions
Keywords
dual approach, laparoscopic hernioplasty
Brief summary
This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)
Detailed description
inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair
Interventions
PROCEDUREdual approach laparoscopic inguinal hernioplasty
after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached
PROCEDURETAPP
pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation
PROCEDURE(lichtenstein) repair
inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
this is a randomized trial where the participants are selected randomly to each of the previous three groups , and the post operative assessment of complication and pain done by different surgical residents whom are not informed about the groups of study.
Intervention model description
comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male patient (older than 18y). * Not complicated. * No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia). * No contraindication for general anesthesia. * Not recurrent.
Exclusion criteria
* any one not in fulfill inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operative time | from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure. | operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow: * from the inflation of the abdomen till deflation and port closure * for Lichtenstein from skin incision to skin closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intra operative bleeding | intraoperative | mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury |
| post operative pain | immediately post operative and 6 ,12, 24 hours and two weeks post operative | pain measured by visual analog scale from 0 no pain to 10 the worst pain ever. |
| intraoperative injuries | intra operative | abdominal visceral injuries cord structure injuries |
| post operative chronic pain | follow up at 3 months , 6 months and one year for pain assessment by VAS | post operative paraesthesia , bricking pain, dull-aching pain. measured by visual analog scale (VAS) from 0 no pain to 10 the worst pain ever |
| recurrence | 3 months, 6 months and one year | post operative inguinal swelling confirmed clinically as a recurrent hernia |
| post operative wound complication | 2 weeks post operative ,3 ,6 and 12 months postoperative | wound seroma , hematoma either small with conservative treatment and large need intervention wound infection either superficial skin and S.C. or mesh infection |
Countries
Egypt
Outcome results
None listed