A comparison of different surgical techniques for incisional hernia treatment

ISRCTN	ISRCTN80014712
DOI	https://doi.org/10.1186/ISRCTN80014712
Protocol serial number	P1-73
Sponsor	Lithuanian University of Health Sciences (Lithuania)
Funder	Lithuanian University of Health Sciences (Lithuania)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Mindaugas Kiudelis
Scientific

Lithuanian University of Health Sciences
Department of Surgery
Eiveniu str. 2
Kaunas
LT 50009
Lithuania

Email	minkiud@yahoo.com

Study information

Primary study design	Interventional
Study design	Prospective randomized controlled study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Recurrence rate
Key secondary outcome measure(s)	1. Postoperative pain 2. Postoperative complications 3. Qualite of life 4. Time of return to full physical activity
Completion date	01/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	100
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

Lithuanian University of Health Sciences

Kaunas
LT 50009
Lithuania

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes