Plain English Summary
Background and study aims:
This study aims to compare two different surgical procedures to treat hernias.
Who can participate?
Male and female participants aged over 60 years, diagnosed with a hernia.
What does the study involve?
Participants will be randomly allocated to one of two groups:
In GROUP R (Reconstruction) - patients will be given the Rives-Stoppa procedure for the repair of the defect.
In GROUP B (Bridging) - patients will be operated on according to standard techniques.
What are the possible benefits and risks of participating?
There will be no immediate benefit to those taking part. However, there should be benefits to patients undergoing hernia repair in the future. There are few risks to the patients taking part and they should not experience any discomfort because he/she will undergo standard surgery by experienced surgeons in the field.
Where is the study run from?
University of Genoa in collaboration with University of Naples.
When is study starting and how long is it expected to run for?
The study will start in December 2012; recruitment will take 12 months and the study is due to end in December 2014.
Who is funding the study?
Sahlgrenska University Hospital, Gothenburg and Swedish Research Council, Sweden.
Who is the main contact?
Dr Cesare Stabilini
cesarestabil@hotmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
LAparoscopic Bridging vs anatomic Open Reconstruction for midline abdominal hernia mesh repair: Long term functional results - Multicenter Randomized Controlled Trial
Acronym
LABOR
Study hypothesis
We hypothesize that a laparoscopic bridging of an abdominal wall hernia (primitive or incisional) could have the same effect in terms of functional result in comparison to an anatomical reconstruction by open approach.
Ethics approval
Not provided at time of registration
Study design
Multicenter non inferiority single blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgical mesh repair of incisional and ventral hernias
Intervention
The patient will be divided in two groups according to the procedure they will undergo:
GROUP R (reconstruction)
Planned number of patients will be submitted to a Rives-Stoppa procedure for the repair of the defect with a lightweight macroporous mesh as described.
GROUP B (bridging)
In this group, patients after randomization will be operated according to standard laparoscopic technique.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Postoperative variations in double leg lowering test (DLL) at 6 and 12 months (as compared to preoperatory)
Secondary outcome measures
1. Differences in Trunk raising test (TR test) at 6 and 12 months
2. Differences in Abdominal Wall Strenght (AWS) score at 6 and 12 months
3. Differences in respiratory function tests at 6 and 12 months
4. Differences in intrabdominal pressure (IAP) pre and postoperative
5. Differences in pain assessed with Visual Analogue Scale (VAS) at 6 and 12 months
6. Differences in quality of life using SF-36 at 6 and 12 months
Overall trial start date
01/11/2012
Overall trial end date
30/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a midline incisional or a ventral primitive hernia
2. Dimension measured on preoperative CT scan:
2.1. Primary ventral hernia ¡Ý4 d ¡Ü10 cm in its greatest diameter ¡°large¡± according to EHS classification)
2.2. Incisional hernias W2 according to EHS classification
3. Both sex
4. 60 years of age
5. BMI<35Kg/m2
6. Give informed consent for randomization
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients with non-midline defects or diastasis recti without herniation
2. Hernia with a previous attempt of mesh repair
3. Hernia is near to a bony salience
4. Patient is classified as American Society of Anesthesiologists class 4 or 5
5. Patient has a severe comorbid condition likely to limit survival to 2 years
6. Patient has cirrhosis with or without ascites
7. Patient is under immunosuppressive treatment has received previous bariatric surgery
8. Patient has bowel obstruction, strangulation, peritonitis, or perforation;
9. Presence of local or systemic infection
10. Neuromuscolar disease likely to impair motility (e.g. previous ictus with reliquate)
11. Patients refusing to participate to the study
Recruitment start date
01/11/2012
Recruitment end date
30/11/2014
Locations
Countries of recruitment
Italy
Trial participating centre
via Nizza 4
Genoa
16145
Italy
Funders
Funder type
University/education
Funder name
University of Genoa (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24165473
Publication citations
-
Protocol
Stabilini C, Bracale U, Pignata G, Frascio M, Casaccia M, Pelosi P, Signori A, Testa T, Rosa GM, Morelli N, Fornaro R, Palombo D, Perotti S, Bruno MS, Imperatore M, Righetti C, Pezzato S, Lazzara F, Gianetta E, Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results., Trials, 2013, 14, 357, doi: 10.1186/1745-6215-14-357.