Core outcome set for clinical studies of postoperative ileus after intestinal surgery

Chapman, Stephen J.; Lee, M J; Blackwell, Sue; Arnott, Robert; Broek, Richard P. G. ten; Delaney, Conor P.; Dudi-Venkata, NN; Fish, Rebecca; Hind, Daniel; Jayne, David; Mellor, Katie; Mishra, Anurag; O’Grady, Greg; Sammour, Tarik; Thorpe, Gabrielle; Wells, Cameron I.; Wolthuis, Albert; Fearnhead, Nicola; Adegbola, S; Bagaglini, Giulia; Bath, M F; Bibby, Neil; Bisset, Carly; Blefari, N; Blencowe, Natalie S; Bolton, William; Bulte, J.P.; Burch, Jale; Campanelli, Maurizio; Cano-Valderrama, Óscar; Carver, Julie; Challand, C; Chan, Shirley Chiu Wai; Chandler, S; Clerc, Daniel; Coe, Peter; Cox, Daniel; Cross, Karen L.; Culkin, Alison; Cuthill, Victoria; Daniels, Sarah; Dawson, Amanda; Dawson, Liza; Dixon, Frederick; Downey, Candice; Drake, Thomas M; Duff, Sarah; Dunning, G. C.; Espín‐Basany, Eloy; Evans, Martin D.D.; Fakhrul‐Aldeen, Mohammed; Fisher, Nigel; Fleetwood‐Beresford, Sahara; Gallo, G; Garoufalia, Zoe; George, R; Han, Jennie; Harji, Deena; Harmston, Rebecca; Harris, David A.; Mohammed, Mary F. Bucklin; Helliwell, Jack; Hepburn, J. W.; Herrod, Philip; Horwood, Natalie; Keane, Celia; Kelly, S. B.; Kroon, Hidde M.; Lonsdale, Maria dos Santos; Major, Giles; Mattison, J. R.; McLean, Andrew; Millán, Mónica; Limbert, S; McDermott, Frank; Mehraj, Asif; Moriarty, Christopher; Moug, Susan; Murray, Edward Croft; Naylor, Maureen; Nepogodiev, Dmitri; Oliver, James; Pandey, Deep Narayan; Pata, Francesco; Paterson, Hugh; Peckham‐Cooper, Adam; Pellino, Gianluca; Pockney, Peter; Proctor, Victoria; Proud, David; Rew, Vanessa; Rutegård, Martin; Sahnan, Kapil; Sayers, Adele; Siragusa, Leandro; Smillie, Robert; Spratt, John S.; Swain, David; Taylor, Sandy; Tejedor, Patricia; Thomas, Owen; THOMPSON, J. M.; Tsimogiannis, Konstantinos E; Tuohey, D; Vissapragada, Ravi; Younis, Mohammed U.; Vaughan-Shaw, P G; Whyte, Ken; Wheelband, Katharine R.; Williams, A; Yates, Adolph J.; Young, Rebekah

doi:10.1093/bjs/znac052

Cited by 11 publications

(2 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A recent multicentric prospective four-cohort study (laparoscopic extracorporeal and ICA; robotic extracorporeal and ICA) demonstrated lower overall complication rates after ICA, specifically less ileus, and PONV after robot-assisted procedures [ 33 ]. However, it is possible that differences in reporting postoperative ileus and differences in the definitions could make a comparison between studies difficult [ 35 , 36 ]. Furthermore, recent evidence suggested that the common assumption of postoperative paralysis might be incorrect and that the distal colon becomes hyperactive following surgery [ 37 ].…”

Section: Discussionmentioning

confidence: 99%

Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision

Sica,

Siragusa,

Pirozzi

et al. 2024

Int J Colorectal Dis

View full text Add to dashboard Cite

Purpose Routine use of abdominal drain or prolonged antibiotic prophylaxis is no longer part of current clinical practice in colorectal surgery. Nevertheless, in patients undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis (ICA), it may reduce perioperative abdominal contamination. Furthermore, in cancer patients, prolonged surgery with extensive dissection such as central vascular ligation and complete mesocolon excision with D3 lymphadenectomy (altogether radical right colectomy RRC) is called responsible for affecting postoperative ileus. The aim was to evaluate postoperative resumption of gastrointestinal functions in patients undergoing right hemicolectomy for cancer with ICA and standard D2 dissection or RRC, with or without abdominal drain and prolonged antibiotic prophylaxis. Methods Monocentric factorial parallel arm randomized pilot trial including all consecutive patients undergoing laparoscopic right hemicolectomy and ICA for cancer, in 20 months. Patients were randomized on a 1:1:1 ratio to receive abdominal drain, prolonged antibiotic prophylaxis or neither (I level), and 1:1 to receive RRC or D2 colectomy (II level). Patients were not blinded. The primary aim was the resumption of gastrointestinal functions (time to first gas and stool, time to tolerated fluids and food). Secondary aims were length of stay and complications’ rate. ClinicalTrials.gov no. NCT04977882. Results Fifty-seven patients were screened; according to sample size, 36 were randomized, 12 for each arm for postoperative management, and 18 for each arm according to surgical techniques. A difference in time to solid diet favored the group without drain or antibiotic independently from standard or RRC. Furthermore, when patients were divided with respect to surgical technique and into matched cohorts, no differences were seen for primary and secondary outcomes. Conclusion Abdominal drainage and prolonged antibiotic prophylaxis in patients undergoing right hemicolectomy for cancer with ICA seem to negatively affect the resumption of a solid diet after laparoscopic right hemicolectomy with ICA for cancer. RRC does not seem to influence gastrointestinal function recovery.

show abstract

Section: Discussionmentioning

confidence: 99%

Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision

Sica,

Siragusa,

Pirozzi

et al. 2024

Int J Colorectal Dis

View full text Add to dashboard Cite

show abstract

“…The patients will stop chewing gum when POI resolves. Resolution of POI will be defined as passage of stool or flatus or both in addition to full filling the criteria defined in the 6 domains described by the Tripartite gastrointestinal recovery post-operative ileus group such as absence of nausea and vomiting, having no need of nasogastric intubation, absence of abdominal pain and distension, and ability to tolerate oral feeds [ 29 ]. Each patient will be offered a watch, notebook, and pen and with the help of the caretaker, record every day’s events and the time they occur.…”

Section: Methodsmentioning

confidence: 99%

Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations: Protocol for a Randomized Controlled Trial

Muhumuza¹,

Molen²,

Mauricio³

et al. 2023

International Journal of Surgery Protocols

View full text Add to dashboard Cite

Background: Prolonged post-operative ileus is associated with increased risk of other complications, length of hospital stays and health care related costs. Chewing gum has been shown to reduce duration of ileus in many elective surgeries, but there is a paucity of randomised controlled trials (RCTs) on its effect on duration of ileus among patients undergoing emergency surgery, specifically patients with peritonitis. The aim of this study is to determine the effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations.Methods: This will be a randomised controlled trial done in 3 hospitals. Fifty-two patients will be randomised to 2 groups. Group A will receive chewing gum in addition to routine care, whereas group B will receive routine care only. The duration of postoperative ileus in the two groups which is the primary outcome, will be compared using the independent samples t-test in SPSS version 22. The length of hospital stay, in-hospital morbidity and mortality will be the secondary outcomes. This trial has been approved by Kampala International University research and Ethics committee (Ref No. KIU-2021-60) and Uganda national council of science and technology (Ref No. HS1665ES). Retrospective registration with the research registry has also been done (UIN: researchregistry8565). Highlights• Prolonged post-operative ileus significantly contributes to adverse surgical outcomes• Chewing gum has been shown to reduce duration of ileus in many elective surgeries• There is paucity of RCTs on role of chewing gum following surgery for peritonitis

show abstract

Electroacupuncture promotes gastrointestinal functional recovery after radical colorectal cancer surgery: a protocol of multicenter randomized controlled trial (CORRECT trial)

Sun,

Wei,

Feng

et al. 2024

Int J Colorectal Dis

View full text Add to dashboard Cite

Introduction The incidence of postoperative gastrointestinal dysfunction (POGD) is notably high among patients following colorectal cancer surgery, highlighting the urgency for the prompt development of efficacious preventive and therapeutic approaches. Electroacupuncture (EA) represents an intervention modality that holds promise for the management of POGD. However, the existing empirical evidence substantiating its efficacy remains scarce. The aim of this study is to evaluate the efficacy and safety of EA as a treatment for POGD in patients undergoing colorectal cancer surgery. Methods This study is a multicenter, parallel-group, randomized controlled trial, named as CORRECT. CORRECT trial will recruit 300 participants diagnosed with colorectal cancer and about to undergo radical surgery across four sub-centers. The participants will be randomly assigned to one of three groups: the EA group, sham-electroacupuncture group, or control group, with a randomization ratio of 2:2:1. All groups will follow a standardized Enhanced Recovery After Surgery (ERAS) protocol. The EA group will receive EA at acupoints LI4 , SJ6 , ST36 , and ST37 , while the SA group will undergo sham-electroacupuncture. The treatments will be administered twice daily from the day of surgery until the fourth day after the operation. The primary endpoint is the time to first flatus, while secondary endpoints encompass time to first defecation, bowel sound emergence, initial water intake, duration of postoperative hospitalization, nausea and vomiting, pain levels, and blinded evaluations. Additional outcomes include medication usage and complication rates, et al. Discussion The CORRECT trial aims to provide high-quality evidence for the role of EA in the treatment of POGD following colorectal cancer surgery. It will contribute data towards the integration of acupuncture into ERAS protocols. Insights from the trial could help in tailoring treatment plans based on individual patient responses to EA, optimizing care on a case-by-case basis. Trial registration Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on November 2023 with the ClinicalTrials.gov Identifier: NCT06128785. URL: https://clinicaltrials.gov/study/NCT06128785?tab=history&a=1#study-details-card . Supplementary information The online version contains supplementary material available at 10.1007/s00384-024-04768-8.

show abstract

Core outcome set for clinical studies of postoperative ileus after intestinal surgery

Cited by 11 publications

References 12 publications

Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision

Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision

Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations: Protocol for a Randomized Controlled Trial

Electroacupuncture promotes gastrointestinal functional recovery after radical colorectal cancer surgery: a protocol of multicenter randomized controlled trial (CORRECT trial)

Contact Info

Product

Resources

About