Inguinal Hernia
Conditions
Keywords
Hernia, laparoscopic, recurrence, pain, inguinal
Brief summary
The purpose of the study is 1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia 2. To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.
Detailed description
Hernia repair is one of the most common surgery performed all over the world. The same is true about India. With more than a billion population, the number of hernia patients in India perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India. Decreased post operative pain and lesser morbidity are the main advantages of Total Extra Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. The disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma formation and difficult learning curve. Fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. This had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair. Requirement of GA for TEP repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We earlier reported that TEP repair could be done without fixation of the mesh under regional anesthesia. This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. The end points measured would be the recurrence of the hernia and pain in the post operative period.
Interventions
PROCEDUREMesh Fixation
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Sponsors
Moulana Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All reducible inguinal hernias will be included in the study
Exclusion criteria
* Irreducible hernia after anesthesia * Obstructed and strangulated hernias * Pediatric hernias * Associated other hernias like ventral hernias * Unfit for spinal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. | 1 year | Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia. |
| Proportion of Patients Having Pain in the Post Operative Period | 1 month | To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | One year | A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day. |
Countries
India
Participant flow
Recruitment details
Between September to December 2008, 120 patients with inguinal hernia presented to randomization at Moulana Hospital, Perianthalmanna, Kerala, India.
Pre-assignment details
15 patients didn't meet inclusion criteria and one patient didn't give consent. 104 patients were randomized to mesh fixation (52 patients) and mesh non-fixation (52 patients). One month and one year follow-up was completed in 100 patients. The follow-up ranged from 15-19 months with a median of 16.2 months.
Participants by arm
| Arm | Count |
|---|---|
| Mesh Fixation Group Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers | 52 |
| Mesh Non Fixation Group The patients in whom the mesh was not fixed by any means | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 |
Baseline characteristics
| Characteristic | Mesh Fixation Group | Mesh Non Fixation Group | Total |
|---|---|---|---|
| Age Continuous | 47.2 years STANDARD_DEVIATION 12.9 | 51.9 years STANDARD_DEVIATION 16.8 | 49.6 years STANDARD_DEVIATION 15.1 |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 51 Participants | 49 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 52 |
| serious Total, serious adverse events | 0 / 48 | 0 / 52 |
Outcome results
Primary
Proportion of Patients Having Pain in the Post Operative Period
To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh Fixation Group | Proportion of Patients Having Pain in the Post Operative Period | 3 Participant |
| Mesh Non Fixation Group | Proportion of Patients Having Pain in the Post Operative Period | 8 Participant |
p-value: 0.2Fisher Exact
Primary
Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.
Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh Fixation Group | Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. | 0 Participant |
| Mesh Non Fixation Group | Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. | 0 Participant |
Secondary
Seroma Formation
A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mesh Fixation Group | Seroma Formation | 5 Participant |
| Mesh Non Fixation Group | Seroma Formation | 8 Participant |
p-value: 0.56Fisher Exact