Postoperative Chronic Pain and Quality of Life following Laparoscopic Trans-Abdominal Preperitoneal (TAPP) Inguinal Hernia Surgery

Randomised Clinical Trial on Postoperative Chronic Pain and Quality of Life following Laparoscopic Trans-Abdominal Preperitoneal (TAPP) Inguinal Hernia Surgery; a Comparison between Mesh Fixation Methods of Tacks, Vicryl Suture, and Non-fixation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200114046127N1

Enrollment

189

Registered

2020-02-20

Start date

2017-04-21

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Condition 1: Unilateral Inguinal hernia. Condition 2: Bilateral Inguinal hernia. Condition 3: Chronic pain after herniotomy. Unilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Bilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Other chronic postprocedural pain

Interventions

Intervention 1: Control group: Patients undergo general anaesthesia and surgery is performed in Trendelenburg position. Thirty minutes before surgery, one gram of cefazoline is injected intravenously.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18, with the diagnosis of uncomplicated primary uni/bilateral reducible inguinal or femoral hernia; Eligible for elective laparoscopic hernia repair and general anaesthesia, ASA (American Society of Anesthesiologists) score of = 3.

Exclusion criteria

Exclusion criteria: Patients with complicated, incarcerated, strangulated, or recurrent hernia; Following medical conditions: coagulopathy, immunosuppression, current anticoagulation treatment, current opioid or alcohol substance abuse, ongoing long term treatment with steroids and analgesics, ASA score > 3, and BMI = 35.

Design outcomes

Primary

Measure	Time frame
Chronic post-herniorrhaphy inguinal pain. Timepoint: 3, 6, and 12 months after surgery. Method of measurement: 100 mm Visual Analogue Scale for assessment of pain intensity.;Post-herniorrhaphy quality of life. Timepoint: 12 months after surgery. Method of measurement: The Medical Outcome Survey SF-36 questionnaire for quality of life evaluation.	—

Secondary

Measure	Time frame
Acute postoperative inguinal pain. Timepoint: 1 and 10 days after surgery. Method of measurement: 100 mm Visual Analogue Scale for assessment of pain intensity.;Intraoperative complications. Timepoint: During surgery. Method of measurement: Intraoperative assessments by the surgeon.;Postoperative complications including surgical site infection, seroma and hematoma formation, orchitis, and neuralgia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination.;Duration of surgery. Timepoint: During surgery. Method of measurement: Timer.;Length of hospital stay. Timepoint: In the first week after surgery. Method of measurement: Recording duration of hospitalization.;Duration of analgesic use for the management of postoperative groin pain. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient.;Time of return to normal daily activities. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient.;Recurrence of hernia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination.	—

Measure

Time frame

Acute postoperative inguinal pain. Timepoint: 1 and 10 days after surgery. Method of measurement: 100 mm Visual Analogue Scale for assessment of pain intensity.;Intraoperative complications. Timepoint: During surgery. Method of measurement: Intraoperative assessments by the surgeon.;Postoperative complications including surgical site infection, seroma and hematoma formation, orchitis, and neuralgia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination.;Duration of surgery. Timepoint: During surgery. Method of measurement: Timer.;Length of hospital stay. Timepoint: In the first week after surgery. Method of measurement: Recording duration of hospitalization.;Duration of analgesic use for the management of postoperative groin pain. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient.;Time of return to normal daily activities. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient.;Recurrence of hernia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sara Aghaei

Esfahan University of Medical Sciences

saraaghaei.nsr@gmail.com+98 31 3668 0048

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026