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The purpose of the study is
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesh Non Fixation Group | No Intervention | Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed by ant means |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh Fixation | Procedure | Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ismail, MBBS, MS | Moulana Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moulana Hospital | Perintalmanna | Kerala | 679322 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18813990 | Background | Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24. | |
| 17885789 | Background | Taylor C, Layani L, Liew V, Ghusn M, Crampton N, White S. Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomised clinical trial. Surg Endosc. 2008 Mar;22(3):757-62. doi: 10.1007/s00464-007-9510-7. Epub 2007 Sep 21. |
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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.
Between September to December 2008, 120 patients with inguinal hernia presented to randomization at Moulana Hospital, Perianthalmanna, Kerala, India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mesh Fixation Group | Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers |
| FG001 | Mesh Non Fixation Group | The patients in whom the mesh was not fixed by any means |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mesh Fixation Group | Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers |
| BG001 | Mesh Non Fixation Group | The patients in whom the mesh was not fixed by any means |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participant | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mesh Fixation Group | Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Ismail, Chief Consultant, Moulana Hospital, Perianthalmanna | Moulana Hospital | 0091-9447128511 | drgargpankaj@yahoo.com, mdismail13@gmail.com |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| D012008 | Recurrence |
| D010146 | Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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|
| One year |
| 10235572 | Background | Ferzli GS, Frezza EE, Pecoraro AM Jr, Ahern KD. Prospective randomized study of stapled versus unstapled mesh in a laparoscopic preperitoneal inguinal hernia repair. J Am Coll Surg. 1999 May;188(5):461-5. doi: 10.1016/s1072-7515(99)00039-3. |
| 21533969 | Derived | Garg P, Nair S, Shereef M, Thakur JD, Nain N, Menon GR, Ismail M. Mesh fixation compared to nonfixation in total extraperitoneal inguinal hernia repair: a randomized controlled trial in a rural center in India. Surg Endosc. 2011 Oct;25(10):3300-6. doi: 10.1007/s00464-011-1708-z. Epub 2011 May 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
The patients in whom the mesh was not fixed by any means |
|
|
| 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. | Posted | Number | Participant | 1 month |
|
|
|
|
| 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. | Posted | Number | Participant | One year |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Mesh Non Fixation Group | The patients in whom the mesh was not fixed by any means | 0 | 52 | 0 | 52 |
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| D010335 | Pathologic Processes |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |