Condition category
Surgery
Date applied
06/09/2012
Date assigned
02/11/2012
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.kmuk.lt/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes