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Prospective, randomized study of chronic pain in the inguinal region and recurrence after inguinal hernia surgery by videolaparoscopy by intra-abdominal technique comparing mesh fixation with staples, glue or just its placement

Prospective , randomize study of inguinodinia and recurrence after videolaparoscopic inguinal hernioplasty by transabdominal technique comparing mesh fixation with tackers , glue or no fixation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6d7twh
Enrollment
Unknown
Registered
2019-10-09
Start date
2017-01-04
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Interventions

63 elective patients from the general surgery clinic underwent inguinal hernioplasty by videolaparoscopic transabdominal technique by the same surgeon (who did not previously know the patient) and th
Procedure/surgery
C23.550.291.937

Sponsors

Hospital de Transplantes Euryclides de Jesus Zerbini
Lead Sponsor
Hospital de Transplantes Euryclides de Jesus Zerbini
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: patients of both genders; age between 18 and 75 years; body mass index (BMI) less than 35 kg / m2; unilateral inguinal hernia patients classified as Nyhus Type II or III; American Society of Anesthesiology Physical State Classification (American Society of Anesthesiology - ASA) I, II and III.

Exclusion criteria

Exclusion criteria: Patients with bilateral inguinal hernia; recurrence , encarcerated; strangled; ; Users of chronic painkillers; Corticosteroid users; patients with fibromyalgia; patients on antidepressants; anxiolytics, carbamazepine, diphenylhydantoin, gabapentin, and pregabalin; patients with previous surgery on the ínguino-crural region; right iliac fossa; hypogastrus; Patients with benign prostatic hyperplasia, not released after urological evaluation; Patients undergoing prostatic surgery for cancer or not; American Society of Anesthesiology (ASA) IV and V Physical State Classification and Users of Illicit Drugs and Alcohol.

Design outcomes

Primary

MeasureTime frame
Assessment and evaluation by physical examination as well as application of quantitative and qualitative pain score and follow-up for 2 years postoperatively in the following periods: 1st postoperative day, 7-15th postoperative day, 3rd postoperative month , 6th Postoperative Month, 1 Year Postoperatively and 2nd Year Postoperatively of patients undergoing transabdominal inguinal hernioplasty by videolaparoscopic technique where after placement of the mesh they were randomized to non-mesh fixation (21 patients) , fixation of the mesh with staples - considered traumatic (21 patients) and fixation of the mesh with. glue - considered non-traumatic (21patients). Where patients who had no fixation or non-traumatic fixation were expected to have less acute pain or chronic postoperative pain.; Given that the proper study has already been analyzed, it was evident that from the point of view of acute or chronic pain there was no difference in non-fixation of the mesh or even fixation with staples or glue in patients undergoing transbadominal videolaparoscopic hernioplasty.

Secondary

MeasureTime frame
Assessment and evaluation by physical examination and follow-up for 2 years postoperatively in the following periods: 1st postoperative day, 7-15th postoperative day, 3rd postoperative month, 6th postoperative month, 1 year Postoperative and 2nd postoperative year of patients undergoing inguinal hernioplasty by videolaparoscopy by transbadominal technique where after mesh placement were randomized into non-mesh fixation (21 patients), mesh fixation with staples - (21 patients ) and fixing the screen with glue - (21patients). Where patients who had not had mesh fixation compared with staple or glue fixation were expected to have a relapse rate.;Given that the proper study has already been analyzed, it was evidenced that all patients were asymptomatic and there were no signs of hernia recurrence regarding non-fixation of the mesh or even fixation with staples or glue in patients submitted to physical examination. inguinal hernioplasty by videolaparoscopy by transbadominal technique

Countries

Brazil

Contacts

Public ContactMauricio Azevedo

Hospital de Transplantes Euryclides de Jesus Zerbini

dr.mauricioazevedo@gmail.com+55 11 973379117

Outcome results

None listed

Source: REBEC (via WHO ICTRP)