BACKGROUND: The aim of this RCT was to determine whether elective resection following successful non-operative management of a first episode of acute sigmoid diverticulitis complicated by extraluminal air with or without abscess is superior to observation in terms of recurrence rates. METHODS: This was a single-centre, sequential design RCT. Patients were randomized to elective surgery or observation following non-operative management and colonoscopy. Non-operative management included nil by mouth, intravenous fluids, intravenous antibiotics, CT with intravenous contrast on arrival at hospital, and repeat CT with intravenous and rectal contrast on day 3 in hospital. The primary endpoint was recurrent diverticulitis at 24 months. Patients with a history of sigmoid diverticulitis, immunosuppression or peritonitis were not included. RESULTS: Of 137 screened patients, 107 were assigned randomly toelective surgery (26) or observation (81), and underwent the allocated intervention after successful non-operative management. Conservative management failed in 15 patients. Groups were similar in age, sex, BMI, co-morbidities and colorectal POSSUM. Rates of recurrent diverticulitis differed significantly in the elective surgery and observation groups (8 versus 32 per cent; P = 0·019) at a mean(s.d.) follow-up of 37·8(8·6) and 35·2(9·2) months respectively. There was also a significant difference in time to recurrence (median 11 versus 7 months; P = 0·015). A total of 28 patients presented with recurrent diverticulitis complicated by extraluminal air and/or abscess (2 elective surgery, 26 observation), all of whom recovered with repeat non-operative management. CONCLUSION: The majority of patients observed following conservative management of diverticulitis with local extraluminal air do not require elective surgery. Registration number: NCT01986686 (http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: The aim of this RCT was to determine whether elective resection following successful non-operative management of a first episode of acute sigmoid diverticulitis complicated by extraluminal air with or without abscess is superior to observation in terms of recurrence rates. METHODS: This was a single-centre, sequential design RCT. Patients were randomized to elective surgery or observation following non-operative management and colonoscopy. Non-operative management included nil by mouth, intravenous fluids, intravenous antibiotics, CT with intravenous contrast on arrival at hospital, and repeat CT with intravenous and rectal contrast on day 3 in hospital. The primary endpoint was recurrent diverticulitis at 24 months. Patients with a history of sigmoid diverticulitis, immunosuppression or peritonitis were not included. RESULTS: Of 137 screened patients, 107 were assigned randomly to elective surgery (26) or observation (81), and underwent the allocated intervention after successful non-operative management. Conservative management failed in 15 patients. Groups were similar in age, sex, BMI, co-morbidities and colorectal POSSUM. Rates of recurrent diverticulitis differed significantly in the elective surgery and observation groups (8 versus 32 per cent; P = 0·019) at a mean(s.d.) follow-up of 37·8(8·6) and 35·2(9·2) months respectively. There was also a significant difference in time to recurrence (median 11 versus 7 months; P = 0·015). A total of 28 patients presented with recurrent diverticulitis complicated by extraluminal air and/or abscess (2 elective surgery, 26 observation), all of whom recovered with repeat non-operative management. CONCLUSION: The majority of patients observed following conservative management of diverticulitis with local extraluminal air do not require elective surgery. Registration number: NCT01986686 (http://www.clinicaltrials.gov).
Authors: Silvia Moler-Zapata; Richard Grieve; David Lugo-Palacios; A Hutchings; R Silverwood; Luke Keele; Tommaso Kircheis; David Cromwell; Neil Smart; Robert Hinchliffe; Stephen O'Neill Journal: Med Decis Making Date: 2022-05-24 Impact factor: 2.749
Authors: Johan Friso Lock; Christian Galata; Christoph Reißfelder; Jörg-Peter Ritz; Thomas Schiedeck; Christoph-Thomas Germer Journal: Dtsch Arztebl Int Date: 2020-08-31 Impact factor: 5.594
Authors: Jessica N Cohan; Brian Orleans; Federica S Brecha; Lyen C Huang; Angela Presson; Angela Fagerlin; Elissa M Ozanne Journal: J Surg Res Date: 2021-01-08 Impact factor: 2.192
Authors: José Manuel Aranda-Narváez; Luis Tallón-Aguilar; Felipe Pareja-Ciuró; Gonzalo Martín-Martín; Antonio Jesús González-Sánchez; Ignacio Rey-Simó; Gonzalo Tamayo-Medel; Carlos Yánez-Benítez; David Costa-Navarro; Soledad Montón-Condón; Salvador Navarro-Soto; Fernando Turégano-Fuentes; María Dolores Pérez-Díaz; José Ceballos-Esparragón; José María Jover-Navalón; José María Balibrea; Salvador Morales-Conde Journal: Cir Esp (Engl Ed) Date: 2020-04-29