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A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair.

Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP - BMC Surg (2010)

Bottom Line: The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh).Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion.Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Heidelberg, Department of Surgery, Germany.

ABSTRACT

Background: Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh).

Methods/design: In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.

Discussion: This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients.

Trial registration: NCT00646334.

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Related in: MedlinePlus

Flow-chart of the trial.
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Figure 1: Flow-chart of the trial.

Mentions: The study is a prospective, randomised, patient and observer blinded study. It is conducted in six centres in Germany. In total eighty patients with incisional hernia meeting the specific inclusion criteria will be randomised and followed for six months thereafter (table 2 and figure 1). Patients who prematurely terminate participation in the study will not be replaced.


A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair.

Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP - BMC Surg (2010)

Flow-chart of the trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2913910&req=5

Figure 1: Flow-chart of the trial.
Mentions: The study is a prospective, randomised, patient and observer blinded study. It is conducted in six centres in Germany. In total eighty patients with incisional hernia meeting the specific inclusion criteria will be randomised and followed for six months thereafter (table 2 and figure 1). Patients who prematurely terminate participation in the study will not be replaced.

Bottom Line: The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh).Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion.Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Heidelberg, Department of Surgery, Germany.

ABSTRACT

Background: Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh).

Methods/design: In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.

Discussion: This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients.

Trial registration: NCT00646334.

Show MeSH
Related in: MedlinePlus