Condition category
Digestive System
Date applied
10/10/2012
Date assigned
07/12/2012
Last edited
30/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Cesare Stabilini

ORCID ID

Contact details

via Nizza 4
Genoa
16145
Italy

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 measures

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

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

Sponsor information

Organisation

University of Genoa (Italy)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24165473

Publication citations

  1. 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.

Additional files

Editorial Notes