Abstract:Background
Delayed return to gut function and prolonged postoperative ileus (PPOI) delay recovery after colorectal surgery. Prucalopride is a selective serotonin-4-receptor agonist that may improve gut motility.
Methods
This was a multicentre, double-blind, parallel, placebo-controlled randomized trial of 2 mg prucalopride versus placebo in patients undergoing elective colorectal resection. Patients with inflammatory bowel di… Show more
“…The initial search in July 2022 identified 150 relevant citations, from which 3 RCTs published between 2015 and 2022 met inclusion criteria. 25–27 The search was updated in January 2024 and identified 24 additional citations, of which none met inclusion criteria. A PRISMA flow diagram of the updated study selection process is illustrated in Figure 1 and 2.Figure 1.PRISMA flowchart for included and excluded studies.Figure 2.Forrest plots for meta-analyzed outcomes.…”
Section: Resultsmentioning
confidence: 99%
“…This was evident in the included studies as administration of prucalopride or placebo was discontinued in approximately 8% of patients in each study arm due to NG insertion or development of PPOI. 26,27 Patients with severe PPOI are in most need of treatment, and it may be important to consider subcutaneous or intravenous forms of medication for more reliable delivery. Of note, Galandiuk et al performed a RCT assessing .5 mg, 2 mg and 4 mg doses of subcutaneous prucalopride vs placebo provided postoperatively in patients undergoing elective colectomies.…”
Section: Discussionmentioning
confidence: 99%
“…In general, patients were older and underwent predominantly laparoscopic elective colorectal operations. 27 Stakenborg et al treated patients with 2 mg 16 and 2 hours preoperatively only. Patients were older and underwent open pancreaticoduodenectomy only.…”
Section: Study and Patient Characteristicsmentioning
confidence: 99%
“…Of note, prucalopride and placebo medications were discontinued in 5 out of 55 patients and 7 out of 55 patients in Gong et al, respectively, and in 6 out of 74 patients and 7 out of 74 patients in Milne et al, respectively, due to inability to tolerate oral intake. 26,27…”
Section: Postoperative Complications and Adverse Eventsmentioning
confidence: 99%
“…20,24,25 Recent randomized controlled trials (RCTs) have assessed the utility of prucalopride in treating PPOI; however, these trials individually involve smaller study populations and have varying results. [25][26][27] This review aims to elucidate whether the use of prucalopride compared to placebo is associated with a reduction in time to return of bowel function in patients undergoing GI surgery.…”
Background Prolonged postoperative ileus (PPOI) contributes to morbidity and prolonged hospitalization. Prucalopride, a selective 5-hydroxytryptamine receptor agonist, may enhance bowel motility. This review assesses whether the perioperative use of prucalopride compared to placebo is associated with accelerated return of bowel function post gastrointestinal (GI) surgery. Methods OVID, CENTRAL, and EMBASE were searched as of January 2024 to identify randomized controlled trials (RCTs) comparing prucalopride and placebo for prevention of PPOI in adult patients undergoing GI surgery. The primary outcomes were time to stool, time to flatus, and time to oral tolerance. The secondary outcomes were incidence of PPOI, length of stay (LOS), postoperative complications, adverse events, and overall costs. The Cochrane risk of bias tool for randomized trials and the Grading of Recommendations, Assessment, Development, and Evaluations framework were used. An inverse variance random effects model was used. Results From 174 citations, 3 RCTs with 139 patients in each treatment group were included. Patients underwent a variety of GI surgeries. Patients treated with prucalopride had a decreased time to stool (mean difference 36.82 hours, 95% CI 59.4 to 14.24 hours lower, I2 = 62%, low certainty evidence). Other outcomes were not statistically significantly different (very low certainty evidence). Postoperative complications and adverse events could not be meta-analyzed due to heterogeneity; yet individual studies suggested no significant differences (very low certainty evidence). Discussion Current RCT evidence suggests that prucalopride may enhance postoperative return of bowel function. Larger RCTs assessing patient important outcomes and associated costs are needed before routine use of this agent.
“…The initial search in July 2022 identified 150 relevant citations, from which 3 RCTs published between 2015 and 2022 met inclusion criteria. 25–27 The search was updated in January 2024 and identified 24 additional citations, of which none met inclusion criteria. A PRISMA flow diagram of the updated study selection process is illustrated in Figure 1 and 2.Figure 1.PRISMA flowchart for included and excluded studies.Figure 2.Forrest plots for meta-analyzed outcomes.…”
Section: Resultsmentioning
confidence: 99%
“…This was evident in the included studies as administration of prucalopride or placebo was discontinued in approximately 8% of patients in each study arm due to NG insertion or development of PPOI. 26,27 Patients with severe PPOI are in most need of treatment, and it may be important to consider subcutaneous or intravenous forms of medication for more reliable delivery. Of note, Galandiuk et al performed a RCT assessing .5 mg, 2 mg and 4 mg doses of subcutaneous prucalopride vs placebo provided postoperatively in patients undergoing elective colectomies.…”
Section: Discussionmentioning
confidence: 99%
“…In general, patients were older and underwent predominantly laparoscopic elective colorectal operations. 27 Stakenborg et al treated patients with 2 mg 16 and 2 hours preoperatively only. Patients were older and underwent open pancreaticoduodenectomy only.…”
Section: Study and Patient Characteristicsmentioning
confidence: 99%
“…Of note, prucalopride and placebo medications were discontinued in 5 out of 55 patients and 7 out of 55 patients in Gong et al, respectively, and in 6 out of 74 patients and 7 out of 74 patients in Milne et al, respectively, due to inability to tolerate oral intake. 26,27…”
Section: Postoperative Complications and Adverse Eventsmentioning
confidence: 99%
“…20,24,25 Recent randomized controlled trials (RCTs) have assessed the utility of prucalopride in treating PPOI; however, these trials individually involve smaller study populations and have varying results. [25][26][27] This review aims to elucidate whether the use of prucalopride compared to placebo is associated with a reduction in time to return of bowel function in patients undergoing GI surgery.…”
Background Prolonged postoperative ileus (PPOI) contributes to morbidity and prolonged hospitalization. Prucalopride, a selective 5-hydroxytryptamine receptor agonist, may enhance bowel motility. This review assesses whether the perioperative use of prucalopride compared to placebo is associated with accelerated return of bowel function post gastrointestinal (GI) surgery. Methods OVID, CENTRAL, and EMBASE were searched as of January 2024 to identify randomized controlled trials (RCTs) comparing prucalopride and placebo for prevention of PPOI in adult patients undergoing GI surgery. The primary outcomes were time to stool, time to flatus, and time to oral tolerance. The secondary outcomes were incidence of PPOI, length of stay (LOS), postoperative complications, adverse events, and overall costs. The Cochrane risk of bias tool for randomized trials and the Grading of Recommendations, Assessment, Development, and Evaluations framework were used. An inverse variance random effects model was used. Results From 174 citations, 3 RCTs with 139 patients in each treatment group were included. Patients underwent a variety of GI surgeries. Patients treated with prucalopride had a decreased time to stool (mean difference 36.82 hours, 95% CI 59.4 to 14.24 hours lower, I2 = 62%, low certainty evidence). Other outcomes were not statistically significantly different (very low certainty evidence). Postoperative complications and adverse events could not be meta-analyzed due to heterogeneity; yet individual studies suggested no significant differences (very low certainty evidence). Discussion Current RCT evidence suggests that prucalopride may enhance postoperative return of bowel function. Larger RCTs assessing patient important outcomes and associated costs are needed before routine use of this agent.
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