Effect of neuromuscular reversal with neostigmine/glycopyrrolate versus sugammadex on postoperative ileus following colorectal surgery.

BACKGROUND: Postoperative ileus (POI) is a common complication following colorectal surgery and is mediated in part by the cholinergic anti-inflammatory pathway (CAIP). Neostigmine (acetylcholinesterase inhibitor), co-administered with glycopyrrolate, is frequently given for neuromuscular reversal before tracheal extubation and modulates the CAIP. An alternative reversal agent, sugammadex (selective rocuronium or vecuronium binder), acts independently from the CAIP. The aim of our study was to assess the impact of neuromuscular reversal agents used during anaesthesia on gastrointestinal recovery. METHODS: Three hundred thirty-five patients undergoing elective colorectal surgery at the Royal Adelaide Hospital between January 2019 and December 2021 were retrospectively included. The primary outcome was GI-2, a validated composite measure of time to diet tolerance and passage of stool. Demographics, 30-day complications and length of stay were collected. Univariate and multivariate analyses were performed. RESULTS: Two hundred twenty-four (66.9%) patients (129 [57.6%] males and 95 [42.4%] females, median age 64 [19-90] years) received neostigmine/glycopyrrolate and 111 (33.1%) received sugammadex (62 [55.9%] males and 49 [44.1%] females, median age 67 [18-94] years). Sugammadex patients achieved GI-2 sooner after surgery (median 3 (0-10) vs. 3 (0-12) days, p = 0.036), and reduced time to first stool (median 2 (0-10) vs. 3 (0-12) days, p = 0.035). Rates of POI, complications and length of stay were similar. On univariate analysis, POI was associated with smoking history, previous abdominal surgery, colostomy formation, increased opioid use and postoperative hypokalaemia (p < 0.05). POI was associated with increased complications, including anastomotic leak and prolonged hospital stay (p < 0.001). On multivariate analysis, neostigmine, bowel anastomoses and increased postoperative opioid use (p < 0.05) remained predictive of time to GI-2. CONCLUSIONS: Patients who received sugammadex had a reduced time to achieving first stool and GI-2. Neostigmine use, bowel anastomoses and postoperative opioid use were associated with delayed time to achieving GI-2.

Impact of timing of reversal of loop ileostomy on patient outcomes: a retrospective cohort study.

BACKGROUND: Diverting loop ileostomies (DLIs) are ideally reversed 6-12 weeks after the index operation. However, reversal surgery is frequently delayed in a real-world setting, with potential implications on patient's quality of life and postoperative complications. The aim of this study was to investigate the impact of timing of the reversal on patient outcomes at a tertiary referral hospital. METHODS: Consecutive patients who underwent elective reversal of loop ileostomy (RLI) between January 2007 and January 2019 were included. The primary outcomes were incidence of postoperative ileus (POI) and 30-day postoperative complications. RESULTS: Of 251 eligible patients, 158 (63%) were men, the median age was 64 years (range 23-88 years), and the most common index operation was an ultra-low anterior resection in 106 (42%). The median time to reversal for the entire cohort was 7.4 months (range 1-28). RLI was performed within 6 months after the index surgery in 89 patients (35%, early group), 6-12 months in 120 (48%, middle group) and after more than 12 months in 42 (17%, late group) patients. A significantly lower incidence of postoperative ileus (13.5% vs. 25.8% vs. 38.1%, p = 0.006), and 30-day postoperative complications (29.2% vs 41.7% vs. 57.1%, p = 0.011) were seen in the early group compared to the middle and late groups, respectively. There was no difference in the return to theater, length of hospital stay, and readmission rate between groups. CONCLUSION: Delayed RLI is associated with increased risk of postoperative complications.

Impact of STIMUlant and osmotic LAXatives (STIMULAX trial) on gastrointestinal recovery after colorectal surgery: randomized clinical trial.

BACKGROUND: Recovery of gastrointestinal (GI) function is often delayed after colorectal surgery. Enhanced recovery protocols (ERPs) recommend routine laxative use, but evidence of benefit is unclear. This study aimed to investigate whether the addition of multimodal laxatives to an ERP improves return of GI function in patients undergoing colorectal surgery. METHODS: This was a single-centre, parallel, open-label RCT. All adult patients undergoing elective colorectal resection or having stoma formation or reversal at the Royal Adelaide Hospital between August 2018 and May 2020 were recruited into the study. The STIMULAX group received oral Coloxyl® with senna and macrogol, with a sodium phosphate enema in addition for right-sided operations. The control group received standard ERP postoperative care. The primary outcome was GI-2, a validated composite measure defined as the interval from surgery until first passage of stool and tolerance of solid intake for 24 h in the absence of vomiting. Secondary outcomes were the incidence of prolonged postoperative ileus (POI), duration of hospital stay, and postoperative complications. The analysis was performed on an intention-to-treat basis. RESULTS: Of a total of 170 participants, 85 were randomized to each group. Median GI-2 was 1 day shorter in the STIMULAX compared with the control group (median 2 (i.q.r. 1.5-4) versus 3 (2-5.5) days; 95 per cent c.i. -1 to 0 days; P = 0.029). The incidence of prolonged POI was lower in the STIMULAX group (22 versus 38 per cent; relative risk reduction 42 per cent; P = 0.030). There was no difference in duration of hospital day or 30-day postoperative complications (including anastomotic leak) between the STIMULAX and control groups. CONCLUSION: Routine postoperative use of multimodal laxatives after elective colorectal surgery results in earlier recovery of gastrointestinal function and reduces the incidence of prolonged POI. Registration number: ACTRN12618001261202 (www.anzctr.org.au).

Safety and efficacy of laxatives after major abdominal surgery: systematic review and meta-analysis.

BACKGROUND: Recovery of gastrointestinal function is often delayed after major abdominal surgery, leading to postoperative ileus (POI). Enhanced recovery protocols recommend laxatives to reduce the duration of POI, but evidence is unclear. This systematic review aimed to assess the safety and efficacy of laxative use after major abdominal surgery. METHODS: Ovid MEDLINE, Embase, Cochrane Library and PubMed databases were searched from inception to May 2019 to identify eligible RCTs focused on elective open or minimally invasive major abdominal surgery. The primary outcome was time taken to passage of stool. Secondary outcomes were time taken to tolerance of diet, time taken to flatus, length of hospital stay, postoperative complications and readmission to hospital. RESULTS: Five RCTs with a total of 416 patients were included. Laxatives reduced the time to passage of stool (mean difference (MD) -0·83 (95 per cent c.i. -1·39 to -0·26) days; P = 0·004), but there was significant heterogeneity between studies for this outcome measure. There was no difference in time to passage of flatus (MD -0·17 (-0·59 to 0·25) days; P = 0·432), time to tolerance of diet (MD -0·01 (-0·12 to 0·10) days; P = 0·865) or length of hospital stay (MD 0·01(-1·36 to 1·38) days; P = 0·992). There were insufficient data available on postoperative complications for meta-analysis. CONCLUSION: Routine postoperative laxative use after major abdominal surgery may result in earlier passage of stool but does not influence other postoperative recovery parameters. Better data are required for postoperative complications and validated outcome measures.

ANTECEDENTES: El retraso en la recuperación de la función gastrointestinal después de una cirugía abdominal mayor es frecuente y conlleva la aparición de un íleo postoperatorio (postoperative ileus, POI). Los protocolos de rehabilitación multimodal recomiendan la utilización de laxantes para reducir la duración del POI, pero su evidencia no es concluyente. Esta revisión sistemática tuvo como objetivo evaluar la seguridad y la eficacia de la utilización de laxantes tras cirugía abdominal mayor. MÉTODOS: Se realizó una búsqueda de los estudio clínicos aleatorizados (randomised controlled trials, RCTs) centrados en la cirugía abdominal mayor electiva, abierta o mínimamente invasiva, en las bases de datos Ovid MEDLINE, EMBASe, Cochrane Library y PubMed, desde el inicio hasta mayo de 2019. La variable principal fue el tiempo transcurrido hasta la primera deposición. Las variables secundarias fueron el tiempo hasta tolerar la dieta, el tiempo hasta la emisión de ventosidades, la duración de la estancia hospitalaria, las complicaciones postoperatorias y los reingresos hospitalarios. RESULTADOS: Se incluyeron cinco RCTs con un total de 416 pacientes. Los laxantes redujeron el tiempo hasta la primera deposición (diferencia media, mean difference, MD − 0,83 (i.c. del 95% −1,39 a −0,26) días; P = 0,004) pero hubo una heterogeneidad significativa entre los estudios para la medida de este resultado. No hubo diferencias en el tiempo hasta la emisión de ventosidades (DM − 0,17 (−0,59 a 0,25) días; P = 0,432), tiempo hasta la tolerancia de la dieta (DM − 0,01 (−0,12 a 0,10) días; P = 0,865) y la duración de la estancia hospitalaria (DM 0,01 (−1,36 a 1,38) días; P = 0,992). No había datos suficientes de las complicaciones postoperatorias para efectuar un metaanálisis. CONCLUSIÓN: El uso rutinario de laxantes en el postoperatorio de una cirugía abdominal mayor puede acelerar el tránsito de heces, pero no influye en otras variables de la recuperación postoperatoria. Se requieren datos de mayor calidad para evaluar las complicaciones postoperatorias y medidas de resultados validadas.

Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction: protocol for a nested methodological study.

INTRODUCTION: Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction. METHOD: An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co-developed and may be combined to form a common output with disease-specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal-group stakeholder discussions; online-facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized. DISSEMINATION AND IMPLEMENTATION: The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi-faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set.