|- candidate number||18374|
|- NTR Number||NTR4687|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jul-2014|
|- Secondary IDs||NL48695.091.14 |
|- Public Title||Prevention of parastomal hernia with a prosthetic mesh in a laparoscopic constructed end-colostomy . |
|- Scientific Title||Prevention of a parastomal hernia after laparoscopic construction of an end-colostomy by reinforcing the abdominal wall with a polypropylene mesh.
The Prevent II trial: A multicenter randomized controlled trial.
|- ACRONYM||Prevent II trial|
|- hypothesis||The use of a low weight polypropylene mesh(PPM) in a sublay position reduce the incidence of parastomal hernia in laparoscopic stoma formation.|
|- Healt Condition(s) or Problem(s) studied||Parastomal hernia, Prophylaxis, Prevention, Laparoscopy, Colostomy, Mesh|
|- Inclusion criteria||1.Elective laparoscopic formation of a permanent end colostomy |
2. Age between 18 and 85 years
3. Signed informed consent
4. Able to understand the study questionnaires
|- Exclusion criteria||1. Expected survival < 12 months|
2. Stoma formation in an emergency setting
3. Previous surgery at the colostomy site
4. Formation of an ileostomy or a loop end ostomy
5. Correction of a previously constructed colostomy
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-sep-2014|
|- planned closingdate||9-mrt-2021|
|- Target number of participants||150|
|- Interventions||The use of a monofilament polypropylene mesh (PPM) in a retromuscular position during laparoscopic creation of an end-colostomy.|
|- Primary outcome||The incidence of parastomal hernia.|
|- Secondary outcome||Perioperative morbidity (stomal necrosis, stenosis, peristomal- or surgical wound infections), mortality, pain, Quality of life, and cost-effectiveness.|
|- Timepoints||3 weeks, 3 months, 1 year, 2 years and 5 years.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. D. Faraj|
|- CONTACT for SCIENTIFIC QUERIES||Drs. D. Faraj|
|- Sponsor/Initiator ||Canisius Wilhelmina Hospital|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Covidien Nederland|
|- Brief summary||Prevention of a parastomal hernia after laparoscopic construction of an end-colostomy by reinforcing the abdominal wall with a polypropylene mesh.
The Prevent II trial: A multicenter randomized controlled trial.|
Background: A Parastomal hernia is a common and invalidating complication after colostomy formation. Prophylactic augmentation of the abdominal wall by a light weight polypropylene mesh at the site of the stoma might prevent a parastomal hernia as was suggested by two small single centered studies. In a recent large multicenter RCT in patients undergoing an open colorectal resection with colostomy formation a statistically significant decrease in incidence of parastomal hernia was determined after one year. However, after the start of the Prevent trial in open surgery, laparoscopic colorectal surgery became more and more popular in the Netherlands. No data is available on the efficacy and safety of prophylactic augmentation of the abdominal wall by a light weight polypropylene mesh in laparoscopic surgery.
Methods: A single-blind (patient) multicenter randomized controlled trial. One hundred and fifty patient will be randomly allocated between placement of a light weight polypropylene mesh during surgery or conventional stoma formation. Patients will be recruited from 10 teaching hospitals in the Netherlands during a period of 18 months. Primary outcome is: the incidence of parastomal hernia, either symptomatic or asymptomatic. Secondary outcome are: perioperative morbidity (stomal necrosis, stenosis, peristomal- or surgical wound infections), mortality, pain, Quality of life, and cost-effectiveness. Patients will be followed at the outpatient clinic for 5 years. Outpatient follow-up is scheduled at 3 weeks, 3 months, 1, 2 and 5 years postoperatively.
Discussion: The PREVENT II-trial is a multicenter randomized controlled trial initiated to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia after a laparoscopic reconstruction of an end-colostomy versus the traditional stoma formation without a mesh.
|- Main changes (audit trail)|
|- RECORD||20-jul-2014 - 12-aug-2014|