The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial
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The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial. / Christoffersen, Mette W; Westen, Mikkel; Assadzadeh, Sami; Deigaard, Søren L; Rosenberg, Jacob; Bisgaard, Thue.
In: Danish Medical Journal, Vol. 61, No. 6, A4865, 06.2014, p. 1-4.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair:
T2 - protocol for a randomised controlled trial
AU - Christoffersen, Mette W
AU - Westen, Mikkel
AU - Assadzadeh, Sami
AU - Deigaard, Søren L
AU - Rosenberg, Jacob
AU - Bisgaard, Thue
PY - 2014/6
Y1 - 2014/6
N2 - INTRODUCTION: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have been reported sporadically, but no evidence is available from randomised controlled trials. The primary purpose of this paper is to compare early post-operative activity-related pain in patients undergoing laparoscopic ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are patient-rated cosmesis and hernia-specific quality of life.METHODS: A randomised, controlled, double-blinded study is planned. Based on power calculation, we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric or umbilical trocar-site hernia repair at Hvidovre Hospital and Herlev Hospital, Denmark, are invited to participate.CONCLUSION: The gap closure technique may induce more post-operative pain than the non-closure repair, but it may also be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.FUNDING: The study is funded by The University of Copenhagen and private foundations.TRIAL REGISTRATION: NCT01962480 (clinicaltrials.gov).
AB - INTRODUCTION: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have been reported sporadically, but no evidence is available from randomised controlled trials. The primary purpose of this paper is to compare early post-operative activity-related pain in patients undergoing laparoscopic ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are patient-rated cosmesis and hernia-specific quality of life.METHODS: A randomised, controlled, double-blinded study is planned. Based on power calculation, we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric or umbilical trocar-site hernia repair at Hvidovre Hospital and Herlev Hospital, Denmark, are invited to participate.CONCLUSION: The gap closure technique may induce more post-operative pain than the non-closure repair, but it may also be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.FUNDING: The study is funded by The University of Copenhagen and private foundations.TRIAL REGISTRATION: NCT01962480 (clinicaltrials.gov).
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Double-Blind Method
KW - Hernia, Ventral
KW - Herniorrhaphy
KW - Humans
KW - Laparoscopy
KW - Middle Aged
KW - Pain, Postoperative
KW - Patient Readmission
KW - Research Design
KW - Surgical Mesh
KW - Wound Closure Techniques
KW - Young Adult
M3 - Journal article
C2 - 24947633
VL - 61
SP - 1
EP - 4
JO - Danish Medical Journal
JF - Danish Medical Journal
SN - 2245-1919
IS - 6
M1 - A4865
ER -
ID: 138178878