Plain English Summary
Background and study aims
Incisional hernias occur when tissue pokes through a surgical wound in the abdomen that has not fully healed. Laparoscopic (keyhole) surgery has better results in terms of pain, quality of life, and time taken to return to full activity, compared with other types of surgery. However, there are many cases when laparoscopic repair is impossible to perform (e.g., large hernia, other illness). The aim of this study is to compare the results of two different incisional hernia repair techniques: sublay and laparoscopic surgery.
Who can participate?
Patients 18 aged 75 with a midline incisional hernia undergoing surgical hernia repair.
What does the study involve?
Participants are randomly allocated to undergo either sublay or laparoscopic surgery.
What are the possible benefits and risks of participating?
The risks include wound complications, bowel injury, and postoperative pneumonia.
Where is the study run from?
Lithuanian University of Health Sciences (Lithuania).
When is the study starting and how long is it expected to run for?
April 2011 to April 2016.
Who is funding the study?
Lithuanian University of Health Sciences (Lithuania).
Who is the main contact?
Linas Venclauskas
linasvenclauskasg@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mindaugas Kiudelis
ORCID ID
Contact details
Lithuanian University of Health Sciences
Department of Surgery
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
-
minkiud@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P1-73
Study information
Scientific title
A comparison of sublay versus laparoscopic surgical techniques for incisional hernia treatment: a prospective randomized study
Acronym
Study hypothesis
The results of sublay and laparoscopic surgery techniques of incisional hernia treatment are similar.
Ethics approval
08/03/2011, ref: P1-73
Study design
Prospective randomized controlled study
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
Surgery for incisional hernia
Intervention
Surgery (hernia repair operations)
Two groups:
1. Sublay technique
2. Laparoscopic technique
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Recurrence rate
Secondary outcome measures
1. Postoperative pain
2. Postoperative complications
3. Qualite of life
4. Time of return to full physical activity
Overall trial start date
01/04/2011
Overall trial end date
01/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with midline incisional hernia undergoing surgical hernia repair
2. Age of patients 18 to 75 years
3. No mental and nervous disorders
4. Patients provide written informed consent to participate in the prospective study before surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 (50 in each group)
Participant exclusion criteria
1. Patients older than 75 years
2. Incarcerated incisional hernia
3. Urgent surgery of the patients (peritonitis, acute bleeding, ileus et ct.) with incisional hernia
4. Patients with mental and nervous disorders
5. Pregnant women with incisional hernia
6. Patients participation in other clinical study
7. Patients resign to participate in the clinical study
Recruitment start date
01/04/2011
Recruitment end date
01/04/2016
Locations
Countries of recruitment
Lithuania
Trial participating centre
Lithuanian University of Health Sciences
Kaunas
LT 50009
Lithuania
Sponsor information
Organisation
Lithuanian University of Health Sciences (Lithuania)
Sponsor details
Department of Surgery
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
-
chirurgijosklinika@kaunoklinikos.lt
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Lithuanian University of Health Sciences (Lithuania)
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