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Introduction: The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. 'PelvEx-Beating the empty pelvis syndrome' aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome. Methods and analysis: A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting. Ethics and dissemination: The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome. Trial registration number: NCT05683795.

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol / C T West, M A West, I Drami, A Denys, T Glyn, P A Sutton, J Tiernan, C Behrenbruch, G Guerra, P S Waters, N Woodward, S Applin, S J Charles, S A Rose, E Pape, G H van Ramshorst, A H Mirnezami, Agj Aalbers, N Abdul Aziz, N Abecasis, M Abraham-Nordling, T Akiyoshi, R Alahmadi, W Alberda, M Albert, M Andric, M Angeles, E Angenete, A Antoniou, J Armitage, R Auer, K K Austin, E Aytac, O Aziz, N Bacalbasa, R P Baker, M Bali, S Baransi, G Baseckas, B Bebington, M Bedford, B K Bednarski, G L Beets, P L Berg, C Bergzoll, J Beynon, S Biondo, K Boyle, L Bordeianou, E Brecelj, A B Bremers, K Brown, M Brunner, P Buchwald, A Bui, A Burgess, Jwa Burger, D Burling, E Burns, N Campain, S Carvalhal, L Castro, A Caycedo-Marulanda, W Ceelen, Kkl Chan, G J Chang, M H Chew, A K Chok, P Chong, H K Christensen, H Clouston, D Collins, A J Colquhoun, J Constantinides, A Corr, M Coscia, M Cosimelli, C Cotsoglou, P E Coyne, R S Croner, L Damjanovic, I R Daniels, M Davies, R J Davies, C P Delaney, Jhw de Wilt, Q D Denost, C Deutsch, D Dietz, S Domingo, E J Dozois, E Drozdov, M Duff, E Egger, T Eglinton, J M Enrique-Navascues, E Espín-Basany, M D Evans, B Eyjólfsdóttir, M Fahy, N S Fearnhead, S Fichtner-Feigl, K Flatmark, F Fleming, B Flor, J Folkesson, K Foskett, F A Frizelle, J Funder, M A Gallego, E García-Granero, J L García-Sabrido, M Gargiulo, V G Gava, L Gentilini, M L George, V George, P Georgiou, A Ghosh, L Ghouti, A Gil-Moreno, F Giner, N Ginther, T Glover, P Goffredo, T Golda, C M Gomez, B Griffiths, F Gwenaël, C Harris, D A Harris, Jaw Hagemans, V Hanchanale, D P Harji, C Helbren, R M Helewa, G Hellawell, A G Heriot, D Hochman, W Hohenberger, T Holm, A Holmström, R Hompes, B Hornung, S Hurton, E Hyun, M Ito, L H Iversen, J T Jenkins, K Jourand, S Kaffenberger, G V Kandaswamy, S Kapur, Y Kanemitsu, M Kaufman, M Kazi, S R Kelley, D S Keller, M E Kelly, S Kersting, Shj Ketelaers, M S Khan, J Khaw, H Kim, H J Kim, R Kiran, C E Koh, Kok Nfm, R Kokelaar, C Kontovounisios, F Kose, M Koutra, M Kraft, Kristensen Hø, S Kumar, M Kusters, V Lago, Z Lakkis, B Lampe, M C Langheinrich, T Larach, S G Larsen, D W Larson, W L Law, S Laurberg, P J Lee, M Limbert, A Loria, M L Lydrup, A Lyons, A C Lynch, M Mackintosh, C Mann, C Mantyh, K L Mathis, Cfs Margues, A Martinez, A Martling, Meijerink Wjhj, A Merchea, S Merkel, A M Mehta, D R McArthur, J J McCormick, F D McDermott, J S McGrath, A McPhee, J Maciel, S Malde, S Manfredelli, S Mikalauskas, D Modest, Jrt Monson, J R Morton, T G Mullaney, A S Navarro, H Neeff, I Negoi, Jwm Neto, B Nguyen, M B Nielsen, Gap Nieuwenhuijzen, P J Nilsson, S Nordkamp, S T O'Dwyer, K Paarnio, G Palmer, E Pappou, J Park, D Patsouras, A Peacock, G Pellino, A C Peterson, F Pfeffer, F Piqeur, J Pinson, G Poggioli, D Proud, M Quinn, A Oliver, A Quyn, R W Radwan, N Rajendran, C Rao, S Rasheed, P C Rasmussen, E Rausa, S E Regenbogen, H M Reims, A Renehan, J Rintala, R Rocha, M Rochester, J Rohila, J Rothbarth, M Rottoli, C Roxburgh, Hjt Rutten, B Safar, P M Sagar, A Sahai, A Saklani, T Sammour, R Sayyed, Amp Schizas, E Schwarzkopf, D Scripcariu, V Scripcariu, G Seifert, C Selvasekar, M Shaban, I Shaikh, D Shida, A Simpson, T Skeie-Jensen, N J Smart, P Smart, J J Smith, T Smith, A M Solbakken, M J Solomon, M M Sørensen, M Spasojevic, S R Steele, D Steffens, K Stitzenberg, L Stocchi, N A Stylianides, T Swartling, H Sumrien, T Swartking, H Takala, E J Tan, C Taylor, D Taylor, P Tejedor, A Tekin, P P Tekkis, J Teras, M R Thanapal, H V Thaysen, E Thorgersen, R Thurairaja, E L Toh, P Tsarkov, J Tolenaar, Y Tsukada, S Tsukamoto, J J Tuech, G Turner, W H Turner, J B Tuynman, M Valente, J van Rees, D van Zoggel, W Vásquez-Jiménez, C Verhoef, M Vierimaa, G Vizzielli, Elk Voogt, K Uehara, C Wakeman, S Warrier, H H Wasmuth, K Weber, M R Weiser, O L Westney, Jmd Wheeler, J Wild, M Wilson, A Wolthuis, H Yano, B Yip, J Yip, R N Yoo, M A Zappa, D C Winter. - In: BMJ OPEN. - ISSN 2044-6055. - ELETTRONICO. - pub ahead of print:(2024), pp. 1-6. [10.1136/bmjopen-2023-076538]

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

M Coscia;M Gargiulo;L Gentilini;G Poggioli;M Rottoli;
2024

Abstract

Introduction: The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. 'PelvEx-Beating the empty pelvis syndrome' aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome. Methods and analysis: A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting. Ethics and dissemination: The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome. Trial registration number: NCT05683795.
2024
BMJ OPEN
Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol / C T West, M A West, I Drami, A Denys, T Glyn, P A Sutton, J Tiernan, C Behrenbruch, G Guerra, P S Waters, N Woodward, S Applin, S J Charles, S A Rose, E Pape, G H van Ramshorst, A H Mirnezami, Agj Aalbers, N Abdul Aziz, N Abecasis, M Abraham-Nordling, T Akiyoshi, R Alahmadi, W Alberda, M Albert, M Andric, M Angeles, E Angenete, A Antoniou, J Armitage, R Auer, K K Austin, E Aytac, O Aziz, N Bacalbasa, R P Baker, M Bali, S Baransi, G Baseckas, B Bebington, M Bedford, B K Bednarski, G L Beets, P L Berg, C Bergzoll, J Beynon, S Biondo, K Boyle, L Bordeianou, E Brecelj, A B Bremers, K Brown, M Brunner, P Buchwald, A Bui, A Burgess, Jwa Burger, D Burling, E Burns, N Campain, S Carvalhal, L Castro, A Caycedo-Marulanda, W Ceelen, Kkl Chan, G J Chang, M H Chew, A K Chok, P Chong, H K Christensen, H Clouston, D Collins, A J Colquhoun, J Constantinides, A Corr, M Coscia, M Cosimelli, C Cotsoglou, P E Coyne, R S Croner, L Damjanovic, I R Daniels, M Davies, R J Davies, C P Delaney, Jhw de Wilt, Q D Denost, C Deutsch, D Dietz, S Domingo, E J Dozois, E Drozdov, M Duff, E Egger, T Eglinton, J M Enrique-Navascues, E Espín-Basany, M D Evans, B Eyjólfsdóttir, M Fahy, N S Fearnhead, S Fichtner-Feigl, K Flatmark, F Fleming, B Flor, J Folkesson, K Foskett, F A Frizelle, J Funder, M A Gallego, E García-Granero, J L García-Sabrido, M Gargiulo, V G Gava, L Gentilini, M L George, V George, P Georgiou, A Ghosh, L Ghouti, A Gil-Moreno, F Giner, N Ginther, T Glover, P Goffredo, T Golda, C M Gomez, B Griffiths, F Gwenaël, C Harris, D A Harris, Jaw Hagemans, V Hanchanale, D P Harji, C Helbren, R M Helewa, G Hellawell, A G Heriot, D Hochman, W Hohenberger, T Holm, A Holmström, R Hompes, B Hornung, S Hurton, E Hyun, M Ito, L H Iversen, J T Jenkins, K Jourand, S Kaffenberger, G V Kandaswamy, S Kapur, Y Kanemitsu, M Kaufman, M Kazi, S R Kelley, D S Keller, M E Kelly, S Kersting, Shj Ketelaers, M S Khan, J Khaw, H Kim, H J Kim, R Kiran, C E Koh, Kok Nfm, R Kokelaar, C Kontovounisios, F Kose, M Koutra, M Kraft, Kristensen Hø, S Kumar, M Kusters, V Lago, Z Lakkis, B Lampe, M C Langheinrich, T Larach, S G Larsen, D W Larson, W L Law, S Laurberg, P J Lee, M Limbert, A Loria, M L Lydrup, A Lyons, A C Lynch, M Mackintosh, C Mann, C Mantyh, K L Mathis, Cfs Margues, A Martinez, A Martling, Meijerink Wjhj, A Merchea, S Merkel, A M Mehta, D R McArthur, J J McCormick, F D McDermott, J S McGrath, A McPhee, J Maciel, S Malde, S Manfredelli, S Mikalauskas, D Modest, Jrt Monson, J R Morton, T G Mullaney, A S Navarro, H Neeff, I Negoi, Jwm Neto, B Nguyen, M B Nielsen, Gap Nieuwenhuijzen, P J Nilsson, S Nordkamp, S T O'Dwyer, K Paarnio, G Palmer, E Pappou, J Park, D Patsouras, A Peacock, G Pellino, A C Peterson, F Pfeffer, F Piqeur, J Pinson, G Poggioli, D Proud, M Quinn, A Oliver, A Quyn, R W Radwan, N Rajendran, C Rao, S Rasheed, P C Rasmussen, E Rausa, S E Regenbogen, H M Reims, A Renehan, J Rintala, R Rocha, M Rochester, J Rohila, J Rothbarth, M Rottoli, C Roxburgh, Hjt Rutten, B Safar, P M Sagar, A Sahai, A Saklani, T Sammour, R Sayyed, Amp Schizas, E Schwarzkopf, D Scripcariu, V Scripcariu, G Seifert, C Selvasekar, M Shaban, I Shaikh, D Shida, A Simpson, T Skeie-Jensen, N J Smart, P Smart, J J Smith, T Smith, A M Solbakken, M J Solomon, M M Sørensen, M Spasojevic, S R Steele, D Steffens, K Stitzenberg, L Stocchi, N A Stylianides, T Swartling, H Sumrien, T Swartking, H Takala, E J Tan, C Taylor, D Taylor, P Tejedor, A Tekin, P P Tekkis, J Teras, M R Thanapal, H V Thaysen, E Thorgersen, R Thurairaja, E L Toh, P Tsarkov, J Tolenaar, Y Tsukada, S Tsukamoto, J J Tuech, G Turner, W H Turner, J B Tuynman, M Valente, J van Rees, D van Zoggel, W Vásquez-Jiménez, C Verhoef, M Vierimaa, G Vizzielli, Elk Voogt, K Uehara, C Wakeman, S Warrier, H H Wasmuth, K Weber, M R Weiser, O L Westney, Jmd Wheeler, J Wild, M Wilson, A Wolthuis, H Yano, B Yip, J Yip, R N Yoo, M A Zappa, D C Winter. - In: BMJ OPEN. - ISSN 2044-6055. - ELETTRONICO. - pub ahead of print:(2024), pp. 1-6. [10.1136/bmjopen-2023-076538]
C T West, M A West, I Drami, A Denys, T Glyn, P A Sutton, J Tiernan, C Behrenbruch, G Guerra, P S Waters, N Woodward, S Applin, S J Charles, S A Rose, E Pape, G H van Ramshorst, A H Mirnezami, Agj Aalbers, N Abdul Aziz, N Abecasis, M Abraham-Nordling, T Akiyoshi, R Alahmadi, W Alberda, M Albert, M Andric, M Angeles, E Angenete, A Antoniou, J Armitage, R Auer, K K Austin, E Aytac, O Aziz, N Bacalbasa, R P Baker, M Bali, S Baransi, G Baseckas, B Bebington, M Bedford, B K Bednarski, G L Beets, P L Berg, C Bergzoll, J Beynon, S Biondo, K Boyle, L Bordeianou, E Brecelj, A B Bremers, K Brown, M Brunner, P Buchwald, A Bui, A Burgess, Jwa Burger, D Burling, E Burns, N Campain, S Carvalhal, L Castro, A Caycedo-Marulanda, W Ceelen, Kkl Chan, G J Chang, M H Chew, A K Chok, P Chong, H K Christensen, H Clouston, D Collins, A J Colquhoun, J Constantinides, A Corr, M Coscia, M Cosimelli, C Cotsoglou, P E Coyne, R S Croner, L Damjanovic, I R Daniels, M Davies, R J Davies, C P Delaney, Jhw de Wilt, Q D Denost, C Deutsch, D Dietz, S Domingo, E J Dozois, E Drozdov, M Duff, E Egger, T Eglinton, J M Enrique-Navascues, E Espín-Basany, M D Evans, B Eyjólfsdóttir, M Fahy, N S Fearnhead, S Fichtner-Feigl, K Flatmark, F Fleming, B Flor, J Folkesson, K Foskett, F A Frizelle, J Funder, M A Gallego, E García-Granero, J L García-Sabrido, M Gargiulo, V G Gava, L Gentilini, M L George, V George, P Georgiou, A Ghosh, L Ghouti, A Gil-Moreno, F Giner, N Ginther, T Glover, P Goffredo, T Golda, C M Gomez, B Griffiths, F Gwenaël, C Harris, D A Harris, Jaw Hagemans, V Hanchanale, D P Harji, C Helbren, R M Helewa, G Hellawell, A G Heriot, D Hochman, W Hohenberger, T Holm, A Holmström, R Hompes, B Hornung, S Hurton, E Hyun, M Ito, L H Iversen, J T Jenkins, K Jourand, S Kaffenberger, G V Kandaswamy, S Kapur, Y Kanemitsu, M Kaufman, M Kazi, S R Kelley, D S Keller, M E Kelly, S Kersting, Shj Ketelaers, M S Khan, J Khaw, H Kim, H J Kim, R Kiran, C E Koh, Kok Nfm, R Kokelaar, C Kontovounisios, F Kose, M Koutra, M Kraft, Kristensen Hø, S Kumar, M Kusters, V Lago, Z Lakkis, B Lampe, M C Langheinrich, T Larach, S G Larsen, D W Larson, W L Law, S Laurberg, P J Lee, M Limbert, A Loria, M L Lydrup, A Lyons, A C Lynch, M Mackintosh, C Mann, C Mantyh, K L Mathis, Cfs Margues, A Martinez, A Martling, Meijerink Wjhj, A Merchea, S Merkel, A M Mehta, D R McArthur, J J McCormick, F D McDermott, J S McGrath, A McPhee, J Maciel, S Malde, S Manfredelli, S Mikalauskas, D Modest, Jrt Monson, J R Morton, T G Mullaney, A S Navarro, H Neeff, I Negoi, Jwm Neto, B Nguyen, M B Nielsen, Gap Nieuwenhuijzen, P J Nilsson, S Nordkamp, S T O'Dwyer, K Paarnio, G Palmer, E Pappou, J Park, D Patsouras, A Peacock, G Pellino, A C Peterson, F Pfeffer, F Piqeur, J Pinson, G Poggioli, D Proud, M Quinn, A Oliver, A Quyn, R W Radwan, N Rajendran, C Rao, S Rasheed, P C Rasmussen, E Rausa, S E Regenbogen, H M Reims, A Renehan, J Rintala, R Rocha, M Rochester, J Rohila, J Rothbarth, M Rottoli, C Roxburgh, Hjt Rutten, B Safar, P M Sagar, A Sahai, A Saklani, T Sammour, R Sayyed, Amp Schizas, E Schwarzkopf, D Scripcariu, V Scripcariu, G Seifert, C Selvasekar, M Shaban, I Shaikh, D Shida, A Simpson, T Skeie-Jensen, N J Smart, P Smart, J J Smith, T Smith, A M Solbakken, M J Solomon, M M Sørensen, M Spasojevic, S R Steele, D Steffens, K Stitzenberg, L Stocchi, N A Stylianides, T Swartling, H Sumrien, T Swartking, H Takala, E J Tan, C Taylor, D Taylor, P Tejedor, A Tekin, P P Tekkis, J Teras, M R Thanapal, H V Thaysen, E Thorgersen, R Thurairaja, E L Toh, P Tsarkov, J Tolenaar, Y Tsukada, S Tsukamoto, J J Tuech, G Turner, W H Turner, J B Tuynman, M Valente, J van Rees, D van Zoggel, W Vásquez-Jiménez, C Verhoef, M Vierimaa, G Vizzielli, Elk Voogt, K Uehara, C Wakeman, S Warrier, H H Wasmuth, K Weber, M R Weiser, O L Westney, Jmd Wheeler, J Wild, M Wilson, A Wolthuis, H Yano, B Yip, J Yip, R N Yoo, M A Zappa, D C Winter
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