Pharmacologic prevention and therapy of postoperative paralytic ileus after gastrointestinal cancer surgery: systematic review and meta-analysis.

BACKGROUND: Postoperative paralytic ileus (POI) is a significant concern following gastrointestinal tumor surgery. Effective preventive and therapeutic strategies are crucial but remain elusive. Current evidence from randomized-controlled trials on pharmacological interventions for prevention or treatment of POI are systematically reviewed to guide clinical practice and future research. MATERIALS AND METHODS: Literature was systematically searched for prospective randomized-controlled trials testing pharmacological interventions for prevention or treatment of POI after gastrointestinal tumor surgery. Meta-analysis was performed using a random effects model to determine risk ratios and mean differences with 95% CI. Risk of bias and evidence quality were assessed. RESULTS: Results from 55 studies, involving 5078 patients who received experimental interventions, indicate that approaches of opioid-sparing analgesia, peripheral opioid antagonism, reduction of sympathetic hyperreactivity, and early use of laxatives effectively prevent POI. Perioperative oral Alvimopan or intravenous administration of Lidocaine or Dexmedetomidine, while safe regarding cardio-pulmonary complications, demonstrated effectiveness concerning various aspects of postoperative bowel recovery [Lidocaine: -5.97 (-7.20 to -4.74)h, P <0.0001; Dexmedetomidine: -13.00 (-24.87 to -1.14)h, P =0.03 for time to first defecation; Alvimopan: -15.33 (-21.22 to -9.44)h, P <0.0001 for time to GI-2 ] and length of hospitalization [Lidocaine: -0.67 (-1.24 to -0.09)d, P =0.02; Dexmedetomidine: -1.28 (-1.96 to -0.60)d, P =0.0002; Alvimopan: -0.58 (-0.84 to -0.32)d, P <0.0001] across wide ranges of evidence quality. Perioperative nonopioid analgesic use showed efficacy concerning bowel recovery as well as length of hospitalization [-1.29 (-1.95 to -0.62)d, P =0.0001]. Laxatives showed efficacy regarding bowel movements, but not food tolerance and hospitalization. Evidence supporting pharmacological treatment for clinically evident POI is limited. Results from one single study suggest that Neostigmine reduces time to flatus and accelerates bowel movements [-37.06 (-40.26 to -33.87)h, P <0.0001 and -42.97 (-47.60 to -38.35)h, P <0.0001, respectively] with low evidence quality. CONCLUSION: Current evidence concerning pharmacological prevention and treatment of POI following gastrointestinal tumor surgery is limited. Opioid-sparing concepts, reduction of sympathetic hyperreactivity, and laxatives should be implemented into multimodal perioperative approaches.

Transcutaneous electrical acupoint stimulation applied in lower limbs decreases the incidence of paralytic ileus after colorectal surgery: A multicenter randomized controlled trial.

BACKGROUND: Postoperative paralytic ileus prolongs hospitalization duration, increases medical expenses, and is even associated with postoperative mortality; however, effective prevention of postoperative paralytic ileus is not yet available. This trial aimed to assess the preventative effectiveness of transcutaneous electrical acupoint stimulation applied in the lower limbs on postoperative paralytic ileus incidence after colorectal surgery. METHODS: After ethics approval and written informed consent, 610 patients from 10 hospitals who were scheduled for colorectal surgery between May 2018 and September 2019 were enrolled. Patients were randomly allocated into the transcutaneous electrical acupoint stimulation (stimulated on bilateral Zusanli, Shangjuxu, and Sanyinjiao acupoints in lower limbs for 30 minutes each time, total 4 times) or sham (without currents delivered) group with 1:1 ratio. The primary outcome was postoperative paralytic ileus incidence, defined as no flatus for >72 hours after surgery. RESULTS: Compared to the sham treatment, transcutaneous electrical acupoint stimulation lowered the postoperative paralytic ileus incidence by 8.7% (32.3% vs 41.0%, P = .026) and decreased the risk of postoperative paralytic ileus by 32% (OR, 0.68; P = .029). Transcutaneous electrical acupoint stimulation also shortened the recovery time to flatus, defecation, normal diet, and bowel sounds. Transcutaneous electrical acupoint stimulation treatment significantly increased median serum acetylcholine by 55% (P = .007) and interleukin-10 by 88% (P < .001), but decreased interleukin-6 by 47% (P < .001) and inducible nitric oxide synthase by 42% (P = .002) at 72 hours postoperatively. CONCLUSION: Transcutaneous electrical acupoint stimulation attenuated the postoperative paralytic ileus incidence and enhanced gastrointestinal functional recovery, which may be associated with increasing parasympathetic nerve tone and its anti-inflammatory actions.

Postoperative ileus-An ongoing conundrum.

BACKGROUND: Postoperative ileus is common and is a major clinical problem. It has been widely studied in patients and in experimental models in laboratory animals. A wide variety of treatments have been tested to prevent or modify the course of this disorder. PURPOSE: This review draws together information on animal studies of ileus with studies on human patients. It summarizes some of the conceptual advances made in understanding the mechanisms that underlie paralytic ileus. The treatments that have been tested in human subjects (both pharmacological and non-pharmacological) and their efficacy are summarized and graded consistent with current clinical guidelines. The review is not intended to provide a comprehensive overview of ileus, but rather a general understanding of the major clinical problems associated with it, how animal models have been useful to elucidate key mechanisms and, finally, some perspectives from both scientists and clinicians as to how we may move forward with this debilitating yet common condition.

Effect of Caffeine Intake on Postoperative Ileus: A Systematic Review and Meta-Analysis.

BACKGROUND: Postoperative ileus prolongs both hospital stay and patients' morbidity, having at the same time a great impact on health care costs. Coffee, a worldwide popular, cheap beverage might have an important effect on the motility of the postoperative bowel. METHODS: PubMed, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched. RESULTS: Four studies met the inclusion criteria of our meta-analysis. A total of 341 patients were included. The postoperative administration of coffee significantly reduces the time to first bowel movement, the time to first flatus and the time to tolerance of solid diet. Safe conclusions could not be drawn regarding the additional use of laxatives, the necessity for reinsertion of nasogastric tube or the need for reoperation as all the aforementioned outcomes did not present any statistically significance. None of the complications were attributed to the administration of coffee. CONCLUSION: The administration of coffee as a postoperative ileus prevention measure can change the way postoperative enhanced recovery is applied. Even though the mechanism of action of coffee is not fully known, currently available literature demonstrates a significant improvement in gastrointestinal motility without having any impact on postoperative morbidity. Studies with higher methodological quality can offer a more careful evaluation of the clinical use of this popular beverage.

Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial.

BACKGROUND: Most patients who undergo abdominal surgery recover bowel movements within a week; however, some suffer prolonged intestinal paralysis or postoperative ileus (POI) leading to complications, such as infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. Chinese medicine is effective for accelerating the recovery of gastrointestinal function after abdominal surgery. Xiangbin prescription (XBP) is the standard prescription for this purpose in our hospital; however, randomized controlled trials of it have not yet been conducted. METHODS/DESIGN: This double-blind, randomized controlled clinical trial aims to recruit patients who have undergone abdominal surgery and experienced postoperative dysmotility to evaluate the efficacy and safety of XBP for preventing POI and accelerating recovery. The research will tackle the common problem of slow recovery of gastrointestinal function after surgery. The participants will be patients who undergo laparoscopic radical resection of rectal carcinoma or laparoscopic panhysterectomy of a benign lesion. Primary outcome measures will be time to first flatus, defecation, normal bowel sounds, and liquid/semi-liquid/general diet. Good Clinical Practice (GCP) standards of efficacy and safety will also be evaluated, along with objective investigation of the mechanism of action of ghrelin. DISCUSSION: This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of XBP for the recovery of gastrointestinal function after surgery, and it will conform to international standards for clinical trials for the recognition of traditional Chinese medicine. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR-TRC-14004156 . Registered on 3 January 2014.

[Does chewing gum improve postoperative results in patients undergoing radical cystectomy? A systematic review of literature and meta-analysis]. / Le chewing-gum améliore-t-il les résultats postopératoires chez les patients opérés d'une cystectomie radicale ? Revue systématique de la littérature et méta-analyse.

INTRODUCTION: Postoperative ileus occurs in different degrees, in the majority of patients undergoing radical cystectomy, which may increase the length of hospital stay. The use of chewing gum has demonstrated its effectiveness in reducing time-to-bowel function and the length of hospital stay in several surgical procedures. OBJECTIVE: To evaluate the benefit of post-operative chewing gum use in patients undergoing radical cystectomy through a systematic review of the literature and meta-analysis. MATERIAL AND METHODS: We performed a literature search of MedLine, Scopus, CochraneLibrary and ClinicalTrials.Gov in March 2017 according to the Cochrane Handbook and the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes. The studies were evaluated according to the "Oxford Center for Evidence-Based Medicine" criteria. The outcome measures evaluated were time-to-flatus, time-to-defecation, length of the hospital stay, and the rates of general and gastrointestinal postoperative complications. Continuous and dichotomous variables were compared respectively using weighted means differences and odds ratios with 95 % confidence intervals. The presence of publication bias was examined by funnel plots. RESULTS: Three studies (including 274 patients in total) met the inclusion criteria. The pooled results demonstrated a 11.82hour reduction in time-to-flatus (95 % CI : -15.43, -8.22h, P <0.00001), and 19.57hours in time-to-defecation (95 % CI : -29.33, -9.81h, P <0.0001), and a decreasing trend of 2.85 days in the length of the hospital stay (95 % CI : -6.13, -0.43, P=0.09), by the use of chewing gum. There was no significant difference between the "chewing gum" and "control" groups in terms of general and gastrointestinal complications (Peto Odds ratio 1.04 [0.60, 1.79], 95 % CI, P=0.89 and Peto Odds ratio 0.65 [0.26, 1.61], 95 % CI, P=0.35 respectively). CONCLUSION: Chewing gum may be recommended postoperatively in patients undergoing radical cystectomy to improve time-to-bowel function.

Abdominal surgery induced gastric ileus and activation of M1-like macrophages in the gastric myenteric plexus: prevention by central vagal activation in rats.

Inflammation plays a role in abdominal surgery (AS)-induced intestinal ileus that is alleviated by electrical vagal stimulation. Intracisternal injection of RX-77368, the stable thyrotropin-releasing hormone agonist, activates dorsal motor nucleus neurons and gastric vagal efferent discharges. We investigated the gastric inflammation induced by AS and the modulation by intracisternal RX-77368 in rats. RX-77368 (50 ng/rat) or saline was injected followed, 1 h later, by laparotomy and small intestinal/cecal manipulation. The sham group had anesthesia alone. After 6 h, gastric emptying (GE) and the inflammation in gastric corpus were determined. AS inhibited GE by 72% vs. control and doubled the number of M1-like macrophage immunoreactive for major histocompatibility complex class II (MHCII; M1 marker) but not for cluster of differentiation 206 (CD206; M2 marker) (MHCII+/CD206-) while there was no change in M2-like macrophages (MHCII-/CD206+). AS increased mRNA levels of interleukin-1ß (IL-1ß) and tumor necrosis factor α (TNF-α) by 1.7- and 1.5-fold, respectively, in the gastric submucosa plus muscle layers and the infiltration of neutrophils labeled by myeloperoxidase by 9.5-fold in the muscularis externa. RX-77368 inhibited AS-related gastric changes while not altering these parameters in the sham group. There was a significant negative correlation between GE and IL-1ß (r = -0.46), TNF-α (r = -0.44), M1 macrophage (r = -0.82), and neutrophils (r = -0.91). The M2-like macrophages and IL-10 expression were unchanged by AS with intracisternal saline or RX-77368. These data indicate that AS activates gastric M1 macrophages and increases proinflammatory cytokines expression, which are prevented by central vagal activation and may contribute to the correlated dampening of postoperative gastric ileus.NEW & NOTEWORTHY MHCII+/CD206- (M1) and MHCII-/CD206+ (M2) constitute two distinct populations of macrophages that are in close apposition to the cholinergic neurons in the rat gastric myenteric plexus (MP). Abdominal surgery (6 h) activates M1 macrophage leading to inflammation in the gastric MP correlated with the delayed gastric emptying, which was abolished by central vagal stimulation via intracisternal injection of RX-77368. Vagal stimulation linked with the cephalic phase may have potential beneficial effects to curtail postoperative gastric ileus.

Intraoperative continuous intestinal loop warming technique A prospective randomised trial.

AIM: The aim of this study is to evaluate if the Intraoperative Continuous Intestinal Loop Warming (ICLW) is a valid trick to decrease the postoperative paralytic ileus. METHODS: The subjects were patients who underwent emergency open abdominal surgery for either benign or malignant diseases. Patients were divided into two groups; group A patients who was secluded for ICLW, and a control group B who was not secluded for ICLW. The primary outcomes were the time of recovery of bowel movement, 30 days postoperative mortality and morbidity, morbidity was graded by the Clavien-Dindo classification of surgical complications. Secondary outcomes were operative time, and length of hospital stay. RESULTS: A total numbers of 100 patients were randomly assigned in this prospective study. The mean time of bowel function recovery in the group A was 41.52 hours, whereas for group B was 67.20 hours, these differences were statistically significant with a P value < 0.05. In group B the bowel function recovery for 64% of the patients took between 72-96 hours furthermore, the longest time for peristaltic recovery was 96 hours which was only observed in patients of group B. There were no intra-operative complication in both groups. There is no difference in the two groups in term of 30 day postoperative morbidity. CONCLUSIONS: Intra-operative continuous intestinal loop warming technique is a simple, safe and low cost technique. It seems that intra-operative continuous intestinal loop warming technique maintain tissues hydration and conserve the body temperature limiting the stress response and help in decreasing the incidence of postoperative paralytic ileus. KEY WORDS: Paralytic Ileus, Postoperative Care, Warming.

Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial.

BACKGROUND: Paralytic ileus that develops after elective surgery is a common and uncomfortable complication and is considered inevitable after an intraperitoneal operation. OBJECTIVE: The purpose of this study was to investigate whether coffee consumption accelerates the recovery of bowel function after complete staging surgery of gynecologic cancers. STUDY DESIGN: In this randomized controlled trial, 114 patients were allocated preoperatively to either postoperative coffee consumption with 3 times daily (n=58) or routine postoperative care without coffee consumption (n=56). Total abdominal hysterectomy and bilateral salpingo-oophorectomy with systematic pelvic and paraaortic lymphadenectomy were performed on all patients as part of complete staging surgery for endometrial, ovarian, cervical, or tubal cancer. The primary outcome measure was the time to the first passage of flatus after surgery. Secondary outcomes were the time to first defecation, time to first bowel movement, and time to tolerance of a solid diet. RESULTS: The mean time to flatus (30.2±8.0 vs 40.2±12.1 hours; P<.001), mean time to defecation (43.1±9.4 vs 58.5±17.0 hours; P<.001), and mean time to the ability to tolerate food (3.4±1.2 vs 4.7±1.6 days; P<.001) were reduced significantly in patients who consumed coffee compared with control subjects. Mild ileus symptoms were observed in 17 patients (30.4%) in the control group compared with 6 patients (10.3%) in the coffee group (P=.01). Coffee consumption was well-tolerated and well-accepted by patients, and no intervention-related side-effects were observed. CONCLUSION: Coffee consumption after total abdominal hysterectomy and systematic paraaortic lymphadenectomy expedites the time to bowel motility and the ability to tolerate food. This simple, cheap, and well-tolerated treatment should be added as an adjunct to the postoperative care of gynecologic oncology patients.

Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. METHODS/DESIGN: Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. DISCUSSION: From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Use of Polyethylene Glycol Electrolyte Solution Expedites Return of Bowel Function and Facilitates Early Discharge after Kidney Transplantation.

BACKGROUND: Delay in the return of bowel function often prolongs hospitalization after kidney transplantation, leading to increased patient morbidity and health care costs. Polyethylene glycol (PEG) solution has been observed to aid the return of bowel function in postoperative patients undergoing abdominal surgery. STUDY DESIGN: Using a 2-arm, single-surgeon, nonrandomized study, we compared the addition of PEG along with early resumption of diet with a control group using only early resumption of diet in kidney transplantation patients. RESULTS: There were 51 subjects in the control group and 47 subjects in the PEG intervention group. The primary outcomes measure, time to bowel movement, was significantly shorter than the control group by an entire day (2.9 ± 1.1 days vs 4.0 ± 1.3 days; p < 0.001). In propensity score analysis, patients receiving PEG had bowel movements sooner (-1.06 ± 0.25 days; p < 0.001) and decreased lengths of stay (-1.16 ± 0.27 days; p < 0.001). CONCLUSIONS: Polyethylene glycol significantly reduced time to return of bowel function and postoperative length of stay. By adding PEG to the postoperative protocol, we can help to reduce costs of hospitalization and improve overall outcomes in renal transplantation patients.

Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial.

BACKGROUND: We assessed the efficacy of TJ-100 taken perioperatively to recovery among patients with periampullary tumor or tumor of the head of the pancreas who underwent pancreaticoduodenectomy (PD). PATIENTS AND METHODS: In this multicenter, randomized, double-blinded, placebo-controlled, phase II trial (JAPAN-PD Study), patients were assigned randomly in a 1:1 ratio to receive TJ-100 or placebo. The coprimary endpoints were (1) incidence of postoperative paralytic ileus lasting >72 hours after surgery and (2) time to occurrence of postoperative paralytic ileus. This trial is registered at the UMIN Clinical Trials Registry (000007975) and at ClinicalTrials.gov (NCT01607307). RESULTS: From August 2012 through July 2013, we assessed 273 patients for eligibility, and 224 underwent randomization; 112 patients received TJ-100, and 112 patients received placebo. The population for analysis consisted of 104 patients who received TJ-100 and 103 who received placebo. Paralytic ileus occurred 35 (33.7%) in the TJ-100 group and 38 (36.9%) in the placebo group (P = .626). Time to first flatus was 2.25 (2.00-2.50) days in the TJ-100 group and 2.50 (1.50-2.50) days in the placebo group (P = .343). Among 23 patients who underwent a pylorus ring-preserving PD, time to first flatus was lower in the TJ-100 group than in the placebo group: 0.50 (0.50-1.00) days versus 1.50 (0.50-3.00) days (P = .034). CONCLUSION: Our findings suggest that use of TJ-100 did not improve recovery from paralytic ileus after PD, and may preclude the routine use of TJ-100 in clinical practice after PD operation.

Paralytic Ileus and Prophylactic Gastrointestinal Motility Medication after Spinal Operation.

PURPOSE: To investigate the prevalence of paralytic ileus after spinal operation in the supine or prone operative position and to determine the efficacy of prophylactic gastrointestinal motility medications in preventing symptomatic paralytic ileus after a spinal operation. MATERIALS AND METHODS: All patients received spinal surgery in the supine or prone operative position. The study period was divided into two phases: first, to analyze the prevalence of radiographic and symptomatic paralytic ileus after a spinal operation, and second, to determine the therapeutic effects of prophylactic gastrointestinal motility medications (postoperative intravenous injection of scopolamine butylbromide and metoclopramide hydrochloride) on symptomatic paralytic ileus after a spinal operation. RESULTS: Basic demographic data were not different. In the first phase of this study, 27 patients (32.9%) with radiographic paralytic ileus and 11 patients (13.4%) with symptomatic paralytic ileus were observed. Radiographic paralytic ileus was more often noted in patients who underwent an operation in the prone position (p=0.044); whereas the occurrence of symptomatic paralytic ileus was not different between the supine and prone positioned patients (p=0.385). In the second phase, prophylactic medications were shown to be ineffective in preventing symptomatic paralytic ileus after spinal surgery [symptomatic paralytic ileus was observed in 11.1% (4/36) with prophylactic medication and 16.7% (5/30) with a placebo, p=0.513]. CONCLUSION: Spinal surgery in the prone position was shown to increase the likelihood of radiographic paralytic ileus occurrence, but not symptomatic paralytic ileus. Unfortunately, the prophylactic medications to prevent symptomatic paralytic ileus after spine surgery were shown to be ineffective.

Multicentre, randomised, placebo-controlled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study).

INTRODUCTION: This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT). METHODS AND ANALYSIS: The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm. ETHICS AND DISSEMINATION: The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: The DKB 14 Study was registered in the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000014326) during 2014.

Perioperative administration of Daikenchuto (TJ-100) reduces the postoperative paralytic ileus in patients with pancreaticoduodenectomy.

BACKGROUND/AIMS: No study has reported whether perioperative administration of Daikenchuto (TJ-100) reduced paralytic ileus after pancreaticoduodenectomy (PD). METHODOLOGY: Forty-five consecutive patients that were scheduled to undergo PD at Wakayama Medical University Hospital between August 2010 and August 2011 were enrolled in this study including the first cohort (n = 15) as the control group and the subsequent cohort (n = 30) as the TJ-100 group. This trial was registered at UMIN-CTR ID# 000005056. RESULTS: Postoperative paralytic ileus occurred more frequently in the control group (73.3% of the control group and 20.0% of the TJ-100 group; p = 0.001). The first passages of flatus significantly improved earlier in the TJ-100 group than in the control group (p = 0.014). A multiple cytokine assay of the drainage and serum showed that IL-9 and IL-10 in the drainage was significantly higher on postoperative day 1 in the TJ-100 group. There were no complications associated with the preoperative administration of TJ-100 before surgery, and no significant differences were observed between the two groups in the incidence of postoperative Gradel-2 diarrhea (CTCAE4.0). CONCLUSIONS: Perioperative administration of TJ-100 was feasible and reduced the incidence of paralytic ileus in PD, and further randomized controlled trials should be conducted.

Efficacy and safety of low-dose celecoxib in reducing post-operative paralytic ileus after major abdominal surgery.

BACKGROUND: A number of interventions have been used to decrease the incidence of post-operative paralytic ileus. A secondary outcome of a randomized controlled study showed that COX-2 inhibitors decreased the incidence of paralytic ileus. We sought to study a large cohort of patients undergoing major abdominal operations who were treated with a COX-2 inhibitor. METHODS: This is a retrospective review of prospectively collected data. All eligible patients were given a COX-2 inhibitor--celecoxib 100 mg--twice daily starting on the day of surgery until the seventh day post-operatively or discharge, whichever was earlier. The rate of paralytic ileus was calculated and compared with historical data. Secondary outcome measures were the effect of using COX-2 inhibitors on renal function, electrolytes and haemoglobin, morbidity and leak rates. RESULTS: Two hundred and fifty-two patients were treated with celecoxib; the control arm consisted of 67 historical patients. Of the 252 patients, we had complete data for 235 patients and ileus in 17 patients (7.23%) compared with 13.4% in the control group (P = 0.05). Subgroup analysis showed ileus in 5.45% of colectomy patients and 6.36% of patients who have had a colectomy and high anterior resection. There was no detriment of measured blood tests. There were leaks in two treated patients, both of whom did not require a laparotomy. CONCLUSIONS: The use of low-dose COX-2 inhibitor over a short period of time decreases the paralytic ileus rates and does not cause any significant morbidity.