A comparison of different surgical techniques for incisional hernia treatment
| ISRCTN | ISRCTN80014712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80014712 |
| Secondary identifying numbers | P1-73 |
- Submission date
- 06/09/2012
- Registration date
- 02/11/2012
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Lithuanian University of Health Sciences
Department of Surgery
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
| minkiud@yahoo.com |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A comparison of sublay versus laparoscopic surgical techniques for incisional hernia treatment: a prospective randomized study |
| Study objectives | The results of sublay and laparoscopic surgery techniques of incisional hernia treatment are similar. |
| Ethics approval(s) | 08/03/2011, ref: P1-73 |
| Health condition(s) or problem(s) studied | Surgery for incisional hernia |
| Intervention | Surgery (hernia repair operations) Two groups: 1. Sublay technique 2. Laparoscopic technique |
| Intervention type | Procedure/Surgery |
| 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 study start date | 01/04/2011 |
| Completion date | 01/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 (50 in each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
LT 50009
Lithuania
Sponsor information
University/education
Department of Surgery
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
| chirurgijosklinika@kaunoklinikos.lt | |
| Website | http://www.kmuk.lt/ |
"ROR" |
https://ror.org/0069bkg23 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
