Optimisation of incision hernia surgery treatment

ISRCTN	ISRCTN45000842
DOI	https://doi.org/10.1186/ISRCTN45000842
Protocol serial number	73/2007
Sponsor	Kaunas Medical University Hospital (Lithuania) - Department of Surgery
Funder	Kaunas Medical University Hospital (Lithuania) - Department of Surgery

Submission date: 19/11/2007
Registration date: 04/03/2008
Last edited: 05/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Linas Venclauskas
Scientific

Eiveniu str. 2
Kaunas
LT50009
Lithuania

Study information

Primary study design	Interventional
Study design	Blinded, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Open mesh repair hernia surgery is better than suture repair hernia surgery of incision hernia treatment 2. The recurrence rate using suture hernia repair technique is much higher than mesh repair technique 3. The recovering time to the normal physical activity after surgery is faster, quality of life is better using mesh repair with sublay technique than mesh repair with onlay technique or suture repair technique of the incision hernia treatment
Ethics approval(s)	Ethics approval received from Kaunas Biomedical Research Ethics Committee on the 5th June 2007 (ref: BE-2-41).
Health condition(s) or problem(s) studied	Hernia
Intervention	Three groups: 1. Keel technique 2. Onlay technique 3. Sublay technique The follow up period is 2 weeks, 1, 3, 6 and 12 months after surgery. Surgery, blood gas analysis and intra-abdominal pressure investigation before and after operation.
Intervention type	Other
Primary outcome measure(s)	1. Recurrence rate, measured at 2 weeks, 1, 3, 6 and 12 months after surgery 2. Quality of life, measured using the 36-item Short Form health survey version 2 (SF-36 v2)at 2 weeks, 1, 3, 6 and 12 months after surgery
Key secondary outcome measure(s)	1. Postoperative complications, measured at 2 weeks, 1, 3, 6 and 12 months after surgery 2. Change of the blood gas and intra-abdominal pressure, measured before and after surgery 3. Recovering time to the normal physical activity after surgery, measured at 2 weeks, 1, 3, 6 and 12 months after surgery
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key inclusion criteria	All 18 - 80 years old patients with incision hernia, who will be operated and agree to participate in this clinical trial.
Key exclusion criteria	1. Patients older than 80 years 2. Incarcerated incision hernia 3. Mental patients with incision hernia 4. Pregnant women with incision hernia 5. Patients with incision hernia do not agree to participate in this clinical trial
Date of first enrolment	01/07/2007
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Lithuania

Study participating centre

Eiveniu str. 2

Kaunas
LT50009
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