Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial
Abstract Background Secondary peritonitis is a severe condition with a 20–32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two me...
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | World Journal of Emergency Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13017-022-00427-x |
| _version_ | 1811324500508147712 |
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| author | Pooya Rajabaleyan Jens Michelsen Uffe Tange Holst Sören Möller Palle Toft Jan Luxhøi Musa Buyukuslu Aske Mathias Bohm Lars Borly Gabriel Sandblom Martin Kobborg Kristian Aagaard Poulsen Uffe Schou Løve Sophie Ovesen Christoffer Grant Sølling Birgitte Mørch Søndergaard Marianne Lund Lomholt Dorthe Ritz Møller Niels Qvist Mark Bremholm Ellebæk The VACOR study group |
| author_facet | Pooya Rajabaleyan Jens Michelsen Uffe Tange Holst Sören Möller Palle Toft Jan Luxhøi Musa Buyukuslu Aske Mathias Bohm Lars Borly Gabriel Sandblom Martin Kobborg Kristian Aagaard Poulsen Uffe Schou Løve Sophie Ovesen Christoffer Grant Sølling Birgitte Mørch Søndergaard Marianne Lund Lomholt Dorthe Ritz Møller Niels Qvist Mark Bremholm Ellebæk The VACOR study group |
| author_sort | Pooya Rajabaleyan |
| collection | DOAJ |
| description | Abstract Background Secondary peritonitis is a severe condition with a 20–32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages. Methods This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. Discussion There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question. Trial Registration The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022. |
| first_indexed | 2024-04-13T14:15:27Z |
| format | Article |
| id | doaj.art-858961af5e224eed98fcedda31ee9bb3 |
| institution | Directory Open Access Journal |
| issn | 1749-7922 |
| language | English |
| last_indexed | 2024-04-13T14:15:27Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | World Journal of Emergency Surgery |
| spelling | doaj.art-858961af5e224eed98fcedda31ee9bb32022-12-22T02:43:40ZengBMCWorld Journal of Emergency Surgery1749-79222022-05-0117111310.1186/s13017-022-00427-xVacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trialPooya Rajabaleyan0Jens Michelsen1Uffe Tange Holst2Sören Möller3Palle Toft4Jan Luxhøi5Musa Buyukuslu6Aske Mathias Bohm7Lars Borly8Gabriel Sandblom9Martin Kobborg10Kristian Aagaard Poulsen11Uffe Schou Løve12Sophie Ovesen13Christoffer Grant Sølling14Birgitte Mørch Søndergaard15Marianne Lund Lomholt16Dorthe Ritz Møller17Niels Qvist18Mark Bremholm Ellebæk19The VACOR study groupResearch Unit for Surgery, Odense University HospitalResearch Unit for Anaesthesiology, Odense University HospitalResearch Unit for Surgery, Odense University HospitalOPEN, Open Patient Data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern DenmarkResearch Unit for Anaesthesiology, Odense University HospitalSurgical Department, Hospital of Southwest JutlandSurgical Department, Hospital of Southwest JutlandSurgical Department, Holbæk HospitalSurgical Department, Holbæk HospitalKarolinska InstituteSurgical Department, Kolding HospitalResearch Unit for Surgery, Odense University HospitalSurgical Department, Viborg HospitalSurgical Department, Viborg HospitalSurgical Department, Viborg HospitalSurgical Department, Viborg HospitalSurgical Department, Aarhus University HospitalSurgical Department, Aarhus University HospitalResearch Unit for Surgery, Odense University HospitalResearch Unit for Surgery, Odense University HospitalAbstract Background Secondary peritonitis is a severe condition with a 20–32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages. Methods This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. Discussion There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question. Trial Registration The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.https://doi.org/10.1186/s13017-022-00427-xSecondary peritonitisFaecal peritonitisVacuum-assisted closurePrimary abdominal closureRelaparotomy on-demand |
| spellingShingle | Pooya Rajabaleyan Jens Michelsen Uffe Tange Holst Sören Möller Palle Toft Jan Luxhøi Musa Buyukuslu Aske Mathias Bohm Lars Borly Gabriel Sandblom Martin Kobborg Kristian Aagaard Poulsen Uffe Schou Løve Sophie Ovesen Christoffer Grant Sølling Birgitte Mørch Søndergaard Marianne Lund Lomholt Dorthe Ritz Møller Niels Qvist Mark Bremholm Ellebæk The VACOR study group Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial World Journal of Emergency Surgery Secondary peritonitis Faecal peritonitis Vacuum-assisted closure Primary abdominal closure Relaparotomy on-demand |
| title | Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial |
| title_full | Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial |
| title_fullStr | Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial |
| title_full_unstemmed | Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial |
| title_short | Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis—the VACOR trial: protocol for a randomised controlled trial |
| title_sort | vacuum assisted closure versus on demand relaparotomy in patients with secondary peritonitis the vacor trial protocol for a randomised controlled trial |
| topic | Secondary peritonitis Faecal peritonitis Vacuum-assisted closure Primary abdominal closure Relaparotomy on-demand |
| url | https://doi.org/10.1186/s13017-022-00427-x |
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