LAparoscopic Bridging vs anatomic Open Reconstruction for midline abdominal hernia mesh repair

ISRCTN ISRCTN93729016
DOI https://doi.org/10.1186/ISRCTN93729016
Secondary identifying numbers N/A
Submission date
10/10/2012
Registration date
07/12/2012
Last edited
30/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Cesare Stabilini
Scientific

via Nizza 4
Genoa
16145
Italy

Study information

Study designMulticenter non inferiority single blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleLAparoscopic Bridging vs anatomic Open Reconstruction for midline abdominal hernia mesh repair: Long term functional results - Multicenter Randomized Controlled Trial
Study acronymLABOR
Study objectivesWe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgical mesh repair of incisional and ventral hernias
InterventionThe 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 typeOther
Primary outcome measurePostoperative variations in double leg lowering test (DLL) at 6 and 12 months (as compared to preoperatory)
Secondary outcome measures1. 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 study start date01/11/2012
Completion date30/11/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2012
Date of final enrolment30/11/2014

Locations

Countries of recruitment

  • Italy

Study participating centre

via Nizza 4
Genoa
16145
Italy

Sponsor information

University of Genoa (Italy)
University/education

Department of surgical sciences (DISC)
L.go Rosanna Benzi 8
Genoa
16132
Italy

ROR logo "ROR" https://ror.org/0107c5v14

Funders

Funder type

University/education

University of Genoa (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 28/10/2013 Yes No