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Suture Techniques to reduce the Incidence of The inCisional Hernia.


- candidate number6581
- NTR NumberNTR2052
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2009
- Secondary IDs2009-026/26225.078.09 MEC/NL
- Public TitleSuture Techniques to reduce the Incidence of The inCisional Hernia.
- Scientific TitleA new technique for prevention of incisional hernia: a blinded randomised controlled trial.
- ACRONYMSTITCH
- hypothesisRecent clinical and experimental data suggest that a relatively new technique with many small tissue bites should be more effective in the prevention of incisional hernia when compared to the standard large bite technique.
We propose a multicenter double blind RCT to compare the routinely used large bite technique with the small bites technique.
- Healt Condition(s) or Problem(s) studiedAbdominal surgery, Incisional hernia, Wound infection
- Inclusion criteria1. Signed informed consent;
2. Midline incision;
3. Age >= 18 years.
- Exclusion criteria1. Previous midline incision within 3 months before surgery;
2. Previous incisional hernia or burst;
3. Abdoman after a midline incision;
4. Pregnancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2012
- Target number of participants550
- InterventionsIn one group of 275 patients the conventional large bites technique will be applied with bites widths of 1,5 cm and inter suture spacing of 1 cm with the use of slowly absorbable 1-0 double loop suture material with a 48 mm needle.
In the other group of 275 patients the small bites technique will be applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of slowly absorbable 2-0 single suture material with a 36 mm needle only in the linea alba. In the small bites technique there will be twice as many stitches with a smaller needle and thinner suture material.
- Primary outcomeIncisional hernia occurence within one year clinically and/or radiographically detected.
- Secondary outcome1. Postoperative complications => burst abdomen and wound infection;
2. Pain;
3. Quality of life;
4. Cost effectiveness.
- TimepointsAt 1 and 12 months, a clinical examination and ultrasound examination will be performed by an examiner blinded to the procedure to examine the midline for any (a-)symptomatic incisional hernias.

Participating patients will be asked to fill in booklets containing quality of life questionnaires before surgery and at 1, 3, 6 and 12 months after surgery.
- Trial web sitewww.stitchtrial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.B. Deerenberg
- CONTACT for SCIENTIFIC QUERIES J.J. Harlaar
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryIncisional hernia is the most common complication after abdominal surgery with a reported incidence of up to 15% at 1 year follow-up. In The Netherlands, 100.000 laparotomies and 4000 incisional hernia repairs are performed annually. The costs of hernia repair (4 kEuro) hence amount to over 16 million euro. Moreover, many patients with incisional hernia are not re-operated due to anticipated recurrence rates of 30-60%. The major factor for development of incisional hernia is the surgical wound failure due to insufficient suture techniques. The latter complication, which occurs in 1-4% of abdominal surgery, involves bursting of the abdominal wound and the muscle layers, which causes the intestines to protrude from the incision. It is associated with a high incidence of surgical site infections, prolonged hospital stay and high mortality rates. Recent clinical and experimental data suggest that a relatively new technique with many small tissue bites should be more effective in the prevention of incisional hernia when compared to the standard large bite technique.
We propose a multicenter double blind RCT to compare the routinely used large bite technique with the small bites technique.

Objective of the study:
Primary question:
1. Which bite size should be used to close a midline incision to prevent incisional hernia?
Secondary questions:
2. Is there a difference in postoperative complications between the two patient groups?
3. Is there a difference in postoperative pain between the two patient groups?
4. Is there a difference in postoperative quality of life between the two patient groups?
5. Is it cost-effective to use the small bites technique?

The trial will be a double blinded randomized controlled prospective trial, in which the large bites technique will be compared with the small bites technique. Patients will be preoperatively randomized in two groups to either receive closure with the large tissue bites technique or with the small tissue bites technique. Patients will be kept unaware of the procedure until the endpoint of the trial. Surgeons or surgical residents and radiologists blinded for the procedure will do outpatient clinic controls.

Study population:
550 surgical patients who will undergo a midline laparotomy will be asked to join this study.
- Main changes (audit trail)
- RECORD12-okt-2009 - 14-jan-2010


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