ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	30 April 2018
Main ID:	ISRCTN76445970
Date of registration:	25/03/2018
Prospective Registration:	No
Primary sponsor:	Sanchinarro University Hospital
Public title:	Cost-effectiveness randomized study of laparoscopic versus open bilateral inguinal hernia repair
Scientific title:	Clinical and cost differences between laparoscopic TAPP versus traditional open Lichteinstein repair for bilateral inguinal hernia
Date of first enrolment:	01/01/2013
Target sample size:	150
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN76445970
Study type:	Interventional
Study design:	This is a clinical and cost-effectiveness analysis of a randomized clinical study comparing laparoscopic trans-abdominal pre-peritoneal (TAPP) technique with open Lichtenstein technique (OL) in bilateral inguinal hernia repair. (Quality of life)
Phase:

Countries of recruitment
Spain

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Benedetto Ielpo
Address:	Sanchinarro University Hospital Calle Oña 10 28050 Madrid Spain
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Bilateral inguinal hernia repair
Surgery
Bilateral inguinal hernia repair

Intervention(s)

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 years), with primary, bilateral inguinal hernias assessed by ultrasound are included.
The patient demographic data recorded are: age, gender, Body Mass Index (BMI), American Society of Anaesthesiology (ASA score), comorbidities and size of hernia according to the European Hernia Society (EHS) classification (Grade I: 1.5 cm, Grade II: 1.5–3 cm, Grade III: >3 cm) (8).

Participants are randomised using a simple randomization with a computer program and divided into two groups according to the surgical approach elected by the computer program: laparoscopic trans-abdominal pre-peritoneal (TAPP) technique with open Lichtenstein technique (OL).

Open Technique (OL):
OL is performed by all surgeons according to the standard Lichtenstein open tension-free technique as described recently by Amid where ilioinguinal and iliohypogastric nerves are usually preserved. No local anesthetic is infiltrated.

Laparoscopic TAPP technique:
This procedure is performed under general anaesthesia. Pneumoperitoneum is established with a Veress needle in the left subcostal space. .The peritoneum is incised and the hernia sac is than isolated and reduced freeing the spermatic cord. Finally, two polypropylene meshes (Prim) of almost 15x10 cm are rolled and introduced in the abdominal cavity bilaterally in both preperitoneal spaces. A unique metal staple is used to secure the mesh to each Cooper ligament (CapSureTM, Bard). The peritoneal flap is than closed using 3 or 4 metal staples for each side.

Participants undergo their surgery according to the protocols in each of their groups. Participants are followed up after surgery to assess their clinical outcomes, quality of life and recurrences of hernia.

Primary Outcome(s)

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 Outcome(s)

Recurrences are measured using outpatient visits after six months

Secondary ID(s)

10203040

Source(s) of Monetary Support

Investigator initiated and funded

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

HM Sanchinarro University Hospital, 01/12/2013

Results

Results available:	Yes
Date Posted:
Date Completed:	10/01/2017
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.