Cost-effectiveness randomized study of laparoscopic versus open bilateral inguinal hernia repair

Clinical and cost differences between laparoscopic TAPP versus traditional open Lichteinstein repair for bilateral inguinal hernia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76445970

Enrollment

150

Registered

2018-03-25

Start date

2013-01-01

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Bilateral inguinal hernia repair Surgery Bilateral inguinal hernia repair

Interventions

This study was carried out in a private hospital in Madrid (Spain) at the General Surgery Department of Sanchinarro University Hospital recruiting patients from March 2013. Patients (aged over 18 year

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Primary, bilateral inguinal hernias assessed by ultrasound

Exclusion criteria

Exclusion criteria: Recurrent hernia

Design outcomes

Primary

Measure	Time frame
1. Clinical outcomes are measured as: 1.1. Time of surgery has been defined since the induction of general anaesthesia and recorded up to the close of the skin 1.2. Length of post-operative stay as well as postoperative complications have been prospectively recorded 1.3. Seroma is defined when it is symptomatic (pain, discomfort, etc..) and that tends to persist for long periods from surgery (> 1 month) and which often requires an interventional therapeutic approach (needle aspiration) 1.4. Postoperative pain was determinated at first and 7th day after surgery and at 2, 6 and 12 months, using the standardized 0-10 visual analgesic scale (VAS). After the discharge, it is gathered in outpatient clinic 1.5. Chronic pain was recorded and defined if it is lasting no less then 3 months after the hernia repair and which requires some analgesic drug 1.6. Number of outpatient surgical visits were also recorded as well as re admission or emergency visit without admission 2. Quality of life was assessed with the medical outcomes study SF-36 questionnaire (Spanish form) preoperatively and at 2, 6 and 12 months after surgery 3. Cost effectiveness is measured using incremental cost-effectiveness ratios (ICERs) at 1 years from surgery. The Institute of Validation of Efficacy Clinic (IVEC) of the HM Hospitals group is responsible for capturing costs ascribed to each patient’s treatment. The total direct hospital costs of care were recorded under the patient’s unique medical record number.	—

Measure

Time frame

1. Clinical outcomes are measured as: 1.1. Time of surgery has been defined since the induction of general anaesthesia and recorded up to the close of the skin 1.2. Length of post-operative stay as well as postoperative complications have been prospectively recorded 1.3. Seroma is defined when it is symptomatic (pain, discomfort, etc..) and that tends to persist for long periods from surgery (> 1 month) and which often requires an interventional therapeutic approach (needle aspiration) 1.4. Postoperative pain was determinated at first and 7th day after surgery and at 2, 6 and 12 months, using the standardized 0-10 visual analgesic scale (VAS). After the discharge, it is gathered in outpatient clinic 1.5. Chronic pain was recorded and defined if it is lasting no less then 3 months after the hernia repair and which requires some analgesic drug 1.6. Number of outpatient surgical visits were also recorded as well as re admission or emergency visit without admission 2. Quality of life was assessed with the medical outcomes study SF-36 questionnaire (Spanish form) preoperatively and at 2, 6 and 12 months after surgery 3. Cost effectiveness is measured using incremental cost-effectiveness ratios (ICERs) at 1 years from surgery. The Institute of Validation of Efficacy Clinic (IVEC) of the HM Hospitals group is responsible for capturing costs ascribed to each patient’s treatment. The total direct hospital costs of care were recorded under the patient’s unique medical record number.

—

Secondary

Measure	Time frame
Recurrences are measured using outpatient visits after six months	—

Countries

Spain

Outcome results

None listed

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