Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial
Auteur(s) :B. Biccard, L. du Toit, M. Lesosky, T. Stephens, L. Myer, Agya B A Prempeh, Nicola J. Vickery, H. Kluyts, A. Torborg, A. Omigbodun, A. Ademuyiwa, M. Elhadi, M. Elfagieh, B. Mbwele, M. Ulisubisya, L. Mboma, D. Ashebir, M. T. Bahta, M. Hassen, Mikiyas G. Teferi, Y. Seman, E. Zoumènou, A. Hewitt-Smith, J. Tumukunde, D. Munlemvo, A. Morais, A. Basenero, P. Ndarukwa, Nazinigouba Ouerdraogo, M. Chaibou, M. Zarouf, A. E. El Adib, V. Gobin, Z. Sanogo, Y. Coulibaly, Z. Ngumi, T. Fadalla, Cynthia Iradukunda, Vénérand Barendegere, I. Smalle, M. Bittaye, A. Samateh, M. Elfiky, M. Fawzy, W. Mulwafu, Vanessa Msosa, L. Lopes, A. Antwi-Kusi, Hamza D. Sama, P. Forget, D. van Straaten, R. Pearse, M. Puchert, Lucy Rolt, Kris Schwebler, F. Kabambi, Tebogo Mabotja, Leandys Cobas, A. Freitas, M. Antunes, Bartolomeu Cabo, Domingos S. Paulo, Carlos Camongua, Yvette Avognon, Osseni Marcos, Raymond Kintomonho, Onesime Demahou, Gisèle Hounsa, H. Chobli, Elie Fassinou, Aurore Zoglobossou, B. Tchaou, C. Tchegnonsi, Fifame Amadji, F. Bossa, E. Ahounou, D. Alao, Roushdane Odérémi, Afissatou Montairou, Oswald Gbéhadé, Romaric Tobome, Adam Boukari, Patrick Bakantieba, Arouna Sambo, Fanou Lionelle, N. Gilbert, Julien Attinon, R. Klikpézo, Aumar Dadjo, D. Fanou, Gilberte Hounkpe, Bachabi Fafana, Néné Nguilu, Bodourin Dossou-Yovo, Chantal Segla, M. Toko, Evelyne Gnele-Dedewanou, Michel Noukounwoui, Ethienne Yado, Timothé Gouroubéra, Valéry Adjignon, S. Mewanou, Aïcha Tchomgang, Urielle Agossou, Fernand Soton, Charbel Azanlin, Lidwine Zomahoun, R. Kaboré, S. Savadogo, Fatou Fleur Rosine Sanou, F. Belem, V. Hien, C. T. H. Bougouma, S. Ouattara, Mariam Kabore, Ouédraogo Nazinigouba, P. Bonkoungou, Martin Lankoandé, M. Traoré, P. Sawadogo, Inès Wenmenga, B. Kinda, A. Simporé, Christian Sapo, S. Traore, Haoua Dipama, Lydie WR Kaboré, Salifou Napon, Telesphore Kabore, Arouna Louré, P. Tondé, C. Zoundi, H. Sanou, R. Ndikumana, C. Nsengiyumva, G. Sund, Alliance Niyukuri, A. Kwizera, J. Niyondiko, A. Kilembe, J. P. Ilunga, N. Sarah, G. Makeya, I. Mwepu, T. Likongo, R. Mvwala, Raphael Mubunda, Noellie Kanka Mukuna, Julie Pembe, N. Ndaye, Eric Bibonge Amisi, Mike Ilunga Madika, Joe Kembo Lungela, Didier Ndonda Mayemba, Philomene Diyoyo, Alex Ngalala, M. Mukenga, P. Kabuni, Dany Bolimo Mpoto, Hervé Mole, Louise Keby, Oria Andavo Buti, Anselme Phaka, Belinda Mayenge, Jean Jeacques Kabuley Kalongo, T. Mawisa, Rodrigue Ngwizani, Kuyala Leya, Dieudonn Kisile Sanduku, Timothe Nkemfuni Mawisa, Coco Nseke Mfumu, Mbuta Bolenge, Desire Kinzenzengu Kabuce, Patrick Kintieti, Amelia Mbuluku, Vicky Mahuwa, Tharcice Khonde Mabiala, Guilain Ngoy, P. Boloko, Nono Mazangama Mvwama, Jose Kengbanda, Pitchou Mushimbonga, Blaise Kuhapala, Nzosani Marcel, Kienze Guylain, Gerard Mboma, S. Sagboze, M. Manika, Jean Pierre Mumbere Kigayi, R. Cishugi, Placide Buhendwa Mugisho, Roger Baguma, Moïse Kongolo, M. Mbayabu, Crispin Mukendi Muamba, Edmond Banema Kapinga, V. Kapinga, Guylain Tshimanga Nsumpi, Patrick Odia, Salomon Bingidimi, Gilbert Kpengbemale, D. H. Imposo, P. Matondo, Servet Lelo, Jeremie Kalambayi, M. Abdel-Ghaffar, A. Soliman, Mostafa Abdelrahman, S. Shehata, A. Rabee, M. Heba, M. R. Abdelfattah, Tamer Ahmed Maher Ghoniem, S. Shehata, Mohamed Lotfy, A. Elhaddad, B. Gebremeskel, Girmay Fisseha, M. Abay, D. Bahrey, Assefa Hika, A. Ali, Kindie Moges, J. Ahmed, D. Abdisa, A. Megersa, Wendwosen Abayne, Haftom Berhane, R. Esayas, F. Kifle, Kokeb Desita, Abebe Addise, Dagim Shimelash, Shitalem Tadesse, Bezaye Zemedkun, P. Kenna, Ayenew Yirdie, Abinet Sisay, Tebikew Gashu, Fassil Mihretu, Yesuf Ahmed, Bekele Debebe, Abdureuf Misgea, Amare Agmas, Rahel Assefa, Abdurahman Gelmo, Seifu Alemu, Brook Damtachew, Merid Mersha, Yaekob Chemere, Samuel Fekadu, Sintayehu Regasa, Bonsa Sileshi, Desalegn Wosen, R. Adamu, G. Mulugeta, T. Bacha, Zewude Gudisa, K. Bekele, Alelign Tasew, Habtamu Gezahegn, D. Atlaw, D. Solomon, Habtemariam Gebresillasie, Girma Tesfaye, Negussie Sarbecha, B. Sahiledengle, Kenbon Seyoum, Gemechu Ganfure, Yohannes Tekalegn, Gosa Tesfaye, Temesgen Ayichew, Shibiru Sendaba, Musefa Redwan, Eyasu Muse, Girma Nina, B. Sime, Addisalem Tadege, Anbesse Jima, Nugusu Ayalew, Dagmawi Workneh, D. Teferi, Momodou T. Nyassi, L. Sanyang, O. Jallow, Abdoulie Keita, Kitabu Jammeh, Charles Roberts, P. Idoko, K. Marenah, Masirending Njie, Musa Marena, Karamba Suwareh, Simon Boissey, Fatoumatta Jarjusey, Awa Jah, Awa Sanyang, Dado Jabbi, Kajali Camara, Armandou Correa, J. Jabang, L. Jaiteh, Lamin Dampha, Aminata Manneh, Baboucarr Sowe, Abdoulie Bah, Edrisa Jawo, V. Okoje, Momodou Baro, Yaya Bah, Mustapha A Njie, Sainabou Mbowe, Ebrima Kanteh, Sarjo Ceesay, Alagie Manneh, E. Atito-Narh, A. Wilson, R. Hussey, E. Okine, J. Kwarteng, Ridge Ntiamoah, S. Dadzie, Mark Aseti, N. Sowah, A. Appiah, Charles Bankah, P. Mburugu, T. Chokwe, P. Olang, V. Gacii, S. Nabulindo, A. Gatheru, T. Mwiti, C. Mwangi, Julius M. Muriithi, D. Ojuka, O. Ogutu, Evans Masitara, M. Chaudhry, Reuben Kamundi, Annmarie Kangangi, T. Massaquoi, S. Takow, Felister Moraa, Aziz Munubi, Moses Kimani, A. Wobenjo, Linda Nguu, Vincent Omeddo, Rose Malaba, Ambrose Nabwana, Anita Mwancha, Alexandria Mugaa, J. Wamwaki, J. Chege, Seymour Sinari, A. Ndonga, R. Shitsinzi, Walter Akello, W. Kimani, Elisha K Kirwa, Seno Saruni, Andrew Wainaina, Ernest Nshom, Aidah Kenseko, K. Shisanya, Purity Wanjiru, Julliah Cherotich, Judy Kimutai, Benson Wahome, Grace Wangui, D. Wamalwa, Stephen Mwangi, Jackson N Chege, Tabitha Wanjiku, Carolyne Njoki, Wachira Waititu, Conrad Ambani, S. Murimi, Sharon Waithira, Nilson Mouti, Collins Kibet, John Kibet, V. Sokobe, Beatrice Jeymah, Antony Kamadi, Faith Gichuri, S. Moses, D. Wasike, Favours Adeya, C. Bitta, S. Ogendo, K. Kariuki, H. Benabdalla, Taha Suliaman, Fatima Ali Abokhzam, M. Isa, Mohammed Huwaysh, Asma Bourawi, Kais Alzubaidy, Mohammed N. Albaraesi, Sumayyah Bahroun, Abdulmueti Alhadi, A. Msherghi, A. Mohamed, A. Khaled, Nouran Aljadi, Elham Bareig, Khaled Elgazwi, Adel Elgazwi, Ibrahim El-busife, Safa Owhida, Almahdi Eltwati, Samah Elakeili, T. Abubaker, Fatima Elkhfeefi, S. Hasan, Amal Alttaira, Imbarkah Elmraied, Rim Wishah, Omar Abugassa, H. Ahmed, A. Ellafi, Shoukrie I Shoukrie, N. Aldokali, Aws ElGammudi, A. Alkaseek, Hoda Elhaddad, A. Alqaarh, A. Brish, Malek Abudsnnuga, Salsabil Albuaishi, M. Albashri, M. Morgom, M. Alawami, Eman I Shawesh, Abdullah Almabrouk, Moaz Alwarfalli, Nagia Abeid, Anis Buzreg, A. Malek, Ameerah Abayu, Butaina Abdulhafith, Wedad Abouruwes, Marim Albakuri, Sabria Almuammari, Esam Alsaghair, Fatheia Alreshi, H. Badi, Rabiee Alfetoey, Naji Zubia, Bushray Almiqlash, Abdulsalam Alshuhoumi, Rayet al islam Ben jouira, A. Dier, Essra Gebril, M. Abdelkabir, S. Moussa, M. Alfitori, Mabroukah Azbeda, Hajar Alamin, Ejmeya Barka, Omlsaad Mosbah, Rema Abdasalam, M. Hiyoum, Maryam Abd allateef, I. Altomi, M. Alsakloul, Ekhlas Karami, Munyah Alriqeeq, M. Omar, Ashraf Samer, Aml Aemeesh, Ahmad Bouhuwaish, Ahmed Elusta, Sultan Ahmeed, Wesal AlFighi Hassan, Mouadah Ali Altayr, Mohamed Addalla, Abrar Geddeda, Kheria Khoja, Doaa Alhaj, Muaad Etturki, A. Elhadi, I. Ellojli, A. Shuwayyah, Ahmed Elfaghih, Malak Alduwayb, Mohamed Aleiyan, Wedad Aboubreeq, S. Alkassem, S. Ashour, H. Ben Hasan, N. Ben Hasan, Ali Yahya, Palesa Chisala, Edward Kommwa, L. Simwinga, Agness Chalira, Precious Kachitsa
Summary Background Risk of mortality following surgery in patients across Africa is twice as high as the global average. Most of these deaths occur on hospital wards after the surgery itself. We aimed to assess whether enhanced postoperative surveillance of adult surgical patients at high risk of postoperative morbidity or mortality in Africa could reduce 30-day in-hospital mortality. Methods We did a two-arm, open-label, cluster-randomised trial of hospitals (clusters) across Africa. Hospitals were eligible if they provided surgery with an overnight postoperative admission. Hospitals were randomly assigned through minimisation in recruitment blocks (1:1) to provide patients with either a package of enhanced postoperative surveillance interventions (admitting the patient to higher care ward, increasing the frequency of postoperative nursing observations, assigning the patient to a bed in view of the nursing station, allowing family members to stay in the ward, and placing a postoperative surveillance guide at the bedside) for those at high risk (ie, with African Surgical Outcomes Study Surgical Risk Calculator scores ≥10) and usual care for those at low risk (intervention group), or for all patients to receive usual postoperative care (control group). Health-care providers and participants were not masked, but data assessors were. The primary outcome was 30-day in-hospital mortality of patients at low and high risk, measured at the participant level. All analyses were done as allocated (by cluster) in all patients with available data. This trial is registered with ClinicalTrials.gov, NCT03853824. Findings Between May 3, 2019, and July 27, 2020, 594 eligible hospitals indicated a desire to participate across 33 African countries; 332 (56%) were able to recruit participants and were included in analyses. We allocated 160 hospitals (13 275 patients) to provide enhanced postoperative surveillance and 172 hospitals (15 617 patients) to provide standard care. The mean age of participants was 37·1 years (SD 15·5) and 20 039 (69·4%) of 28 892 patients were women. 30-day in-hospital mortality occurred in 169 (1·3%) of 12 970 patients with mortality data in the intervention group and in 193 (1·3%) of 15 242 patients with mortality data in the control group (relative risk 0·96, 95% CI 0·69–1·33; p=0·79). 45 (0·2%) of 22 031 patients at low risk and 309 (5·6%) of 5500 patients at high risk died. No harms associated with either intervention were reported. Interpretation This intervention package did not decrease 30-day in-hospital mortality among surgical patients in Africa at high risk of postoperative morbidity or mortality. Further research is needed to develop interventions that prevent death from surgical complications in resource-limited hospitals across Africa. Funding Bill & Melinda Gates Foundation and the World Federation of Societies of Anaesthesiologists. Translations For the Arabic, French and Portuguese translations of the abstract see Supplementary Materials section.