Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure

Loop ileostomy closure after colorectal surgery is often associated with Postoperative ileus, with an incidence between 13–20%. The aim of this study is to evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to ileostomy closure in patients operated on for colorectal carcinoma. For this, a prospective, randomized, double-blind, controlled study is designed. All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included. Randomized and divided into two groups, 34 cases and 35 controls were included in the study. Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay were evaluated. The incidence of Postoperative ileus was similar in both groups, 9/34 patients stimulated with probiotics and 10/35 in the control group (CG) with a p = 0.192. The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation. Postoperative ileus after closure ileostomy is independent of stimulation of the ileostomy with probiotics through the efferent loop. There seem to be a relationship between Postoperative ileus after reconstruction and the previous existence of Postoperative ileus after colorectal cancer surgery.

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Diversion Colitis: Macro and Microscopic Findings after Probiotics Stimulation

Biology ◽

10.3390/biology10040303 ◽

2021 ◽

Vol 10 (4) ◽

pp. 303

Author(s):

Ángela Rodríguez-Padilla ◽

Germán Morales-Martín ◽

Rocío Pérez-Quintero ◽

Juan Gómez-Salgado ◽

Ricardo Rada-Morgades ◽

...

Keyword(s):

Loop Ileostomy ◽

Controlled Study ◽

Control Group ◽

Short Term ◽

Double Blind ◽

Diversion Colitis ◽

Follicular Hyperplasia ◽

Protective Ileostomy ◽

And Function ◽

Stimulation Of

The use of a loop ileostomy as the defunctioning procedure of choice to protect a distal colonic anastomosis causes histological and endoscopic changes in the intestinal mucosal architecture, which have been related to chronic inflammation and changes in the microflora that consequently impact the intestinal structure and function following fecal stream diversion. The aim of this study was to evaluate the histological and endoscopic changes on the colonic mucosa in patients with diversion colitis after stimulation of the efferent loop with probiotics prior to closure of the protective ileostomy. A prospective, randomized, double-blind, controlled study was designed. All patients who underwent surgery for colorectal carcinoma with protective ileostomy between January 2017 and December 2018 were included. These patients were pending reconstructive surgery and were diagnosed with endoscopic and histological diversion colitis. Divided into two groups, a group stimulated with probiotics (SG) and a control group (CG). 34 cases and 35 controls were included in the study. Histological and endoscopic changes were evaluated after stimulation, after restorative surgery and during the short-term follow-up after surgery. A decrease in endoscopic pathological findings (mucosal friability, mucous erosions, polyps, edema, erythema and stenosis) and in histological findings (follicular hyperplasia, eosinophils, cryptic abscesses, lymphocyte infiltration, plasma cell infiltration and architecture distortion) was observed in SG. These results were statistically significant with a p < 0.001. The stimulation of the efferent loop of the ileostomy in patients with diversion colitis produced a decrease of the endoscopic and histological severity of colitis in the short term.

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Acupuncture and Postoperative Vomiting in Day-Stay Paediatric Patients

Anaesthesia and Intensive Care ◽

10.1177/0310057x9602400607 ◽

1996 ◽

Vol 24 (6) ◽

pp. 674-677 ◽

Cited By ~ 20

Author(s):

K. L. Schwager ◽

D. B. Baines ◽

R. J. Meyer

Keyword(s):

Adult Population ◽

Acupuncture Point ◽

Controlled Study ◽

Control Group ◽

Postoperative Vomiting ◽

Double Blind ◽

Paediatric Patients ◽

Transcutaneous Stimulation ◽

Significant Difference ◽

Stimulation Of

The stimulation of the acupuncture point P6 has been used to prevent nausea and vomiting in the adult population. It has, however, been subject to limited comparative evaluation in children. We proposed that stimulation of P6 and the analgesic point Li4 would reduce the incidence of postoperative vomiting. Eighty-four unpremedicated paediatric patients having day-stay surgery (circumcision or herniotomy/orchidopexy) were included in a randomized, double-blind, placebo-controlled study of transcutaneous stimulation of P6 and Li4 or no stimulation. The incidence of vomiting was recorded for 24 hours postoperatively. There was no statistically significant difference in total postoperative vomiting in those patients who were stimulated, compared with the control group (P=0.909), or between any group for postoperative vomiting in the recovery ward, day-stay ward or at home. For all groups, vomiting was more common within the first four hours and more likely to occur in the day-stay ward.

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Diversion Colitis and Probiotic Stimulation: Effects of Bowel Stimulation Prior to Ileostomy Closure

Frontiers in Medicine ◽

10.3389/fmed.2021.654573 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ángela Rodríguez-Padilla ◽

Germán Morales-Martín ◽

Rocío Pérez-Quintero ◽

Ricardo Rada-Morgades ◽

Juan Gómez-Salgado ◽

...

Keyword(s):

Colorectal Carcinoma ◽

Reconstructive Surgery ◽

Controlled Study ◽

Short Term ◽

Double Blind ◽

Diversion Colitis ◽

Colonic Flora ◽

Protective Ileostomy ◽

Index Of Severity ◽

Stimulation Of

Background: Diversion colitis is a non-specific inflammation of a defunctionalised segment of the colon after a temporary stoma has been performed. This inflammation is associated with a change in the colonic flora.Aim: To evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to closure of the protective ileostomy in patients operated on colorectal carcinoma and its effect on diversion colitis. A prospective, randomised, double-blind, controlled study is carried out.Methods: Patients who underwent surgery for colorectal carcinoma with protective ileostomy pending reconstructive surgery and with diversion colitis as diagnosis are included. Randomised and divided into two groups. Histological and endoscopic changes were evaluated after stimulation, after restorative surgery and during the short-term follow-up after surgery.Results: Patients in CG were distributed according to the endoscopic index of severity in pre-stimulation/post-stimulation as follows: severe n = 9/9 (25.7%), moderate n = 23/23 (65.7%), and mild n = 3/3 (8.6%); compared to the distribution in SG, severe n = 9/0 (26.5/0%), moderate n = 23/3 (67.6/8.8%), mild n = 2/19 (5.9/55.9%) and normal colonoscopy in 0/12 patients (0/35.3%).Conclusion: Probiotic stimulation of the efferent loop is a safe and effective method, managing to reduce both macroscopic and microscopic colitis, as well as a decrease in symptoms in the short term after reconstructive surgery.

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CHRONIC ASTHMA IN CHILDHOOD: DOUBLE-BLIND CONTROLLED STUDY OF TREATMENT WITH GAMMA-GLOBULIN

PEDIATRICS ◽

10.1542/peds.21.6.980 ◽

1958 ◽

Vol 21 (6) ◽

pp. 980-993

Author(s):

Rosalind S. Abernathy ◽

Edward L. Strem ◽

Robert A. Good

Keyword(s):

Gamma Globulin ◽

Normal Population ◽

Physical Growth ◽

Controlled Study ◽

Control Group ◽

Chronic Asthma ◽

Blood Proteins ◽

Double Blind ◽

Chemical Determination ◽

Complete Blood Counts

To evaluate the effect of injections of gamma-globulin upon the course of asthma, observations were made with 22 asthmatic children ranging in age from 1½ to 5½ years. They had suffered from asthma from 1 to 13 years and were selected as subjects because they had not made satisfactory improvement under allergic management over an average of 2.4 years. They were placed in two groups by random assignment, one of which received injections of gamma-globulin. Without knowledge of the treatment being given, one author examined each child at the time of each injection and one month after the last injection. Roentgenograms, vital capacity, complete blood counts and chemical determination of the blood proteins were performed at the initial and final visits. Fifteen of the twenty-two patients improved clinically, eight in the treatment group and seven in the control group. No significant differences between the groups were noted in the amount of asthma, physical growth, hemoglobin value or eosinophilia. The concentration of gamma-globulin in the serum increased in the treated patients. Nevertheless, there was no difference in the incidence of infection in the two groups and in both it was equal to that in a normal population. This double-blind controlled study offers no evidence to support the view that treatment with gamma-globulin has a beneficial effect on the course of chronic asthma in children.

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Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/6452709 ◽

2018 ◽

Vol 2018 ◽

pp. 1-15

Author(s):

Ranran Chen ◽

Dianrong Song ◽

Wei Zhang ◽

Guanwei Fan ◽

Yingqiang Zhao ◽

...

Keyword(s):

Drug Withdrawal ◽

Endometrial Thickness ◽

Vaginal Epithelium ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo ◽

Vulvovaginal Atrophy ◽

Normal Ranges ◽

And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

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Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

Journal of Hand Surgery (European Volume) ◽

10.1016/0266-7681(92)90014-s ◽

1992 ◽

Vol 17 (1) ◽

pp. 69-70 ◽

Cited By ~ 79

Author(s):

M. A. LAMBERT ◽

R. J. MORTON ◽

J. P. SLOAN

Keyword(s):

Local Anaesthetic ◽

Steroid Injection ◽

Controlled Trial ◽

Trigger Finger ◽

Controlled Study ◽

Control Group ◽

Methylprednisolone Acetate ◽

Double Blind ◽

Local Steroid Injection ◽

Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

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2838. Safety and Immunogenicity of a gp120-CD4 Chimeric Subunit Vaccine: A Phase 1a Randomized Controlled Trial

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz359.143 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S65-S66

Author(s):

Joel V Chua ◽

Charles Davis ◽

Amy Nelson ◽

Ka Wing J Lam ◽

Lydiah Mutumbi ◽

...

Keyword(s):

Subunit Vaccine ◽

Vaccine Development ◽

Controlled Trial ◽

Chimeric Protein ◽

Controlled Study ◽

Control Group ◽

Single Chain ◽

Double Blind ◽

Humoral Responses ◽

Hiv 1

Abstract Background A primary challenge for HIV vaccine development is to raise antiviral antibodies capable of recognizing highly variable viral antigens. The full-length single chain (FLSC) gp120-CD4 chimeric protein was designed to present a highly conserved CD4-induced HIV-1 envelope structure that evokes cross-reactive humoral responses (Figure 1). IHV01 is an FLSC subunit vaccine formulated in alum adjuvant. The safety and immunogenicity of IHV01 was evaluated in this first-in-human phase 1a trial. Methods This randomized, double-blind placebo-controlled study involved three dose-escalating cohorts (75 µg, 150 µg, and 300 µg doses). Eligible participants were HIV-1 uninfected healthy volunteers aged 18 to 45 years. Participants in each cohort were block randomized in groups of four in a 3:1 ratio to receive either vaccine or placebo. Intramuscular injections were given on weeks 0, 4, 8, and 24. Participants were followed for an additional 24 weeks after the last immunization. Crossreactive antibody binding titers against diverse HIV envelopes and antigens and specific CD4i epitopes on gp120 were assessed. Results Sixty-five volunteers were enrolled—49 vaccine and 16 placebo. Majority (81%) of vaccinations with IHV01 produced no localized or systemic reactions; no different from the control group. The overall incidence of adverse events (AEs) was not significantly different between groups. Majority (89%) of vaccine-related AEs were mild in severity. The most common vaccine-related AEs were injection site pain (31%), pruritus (10%), and headache (10%). There were no vaccine-related serious AE, discontinuation due to AE, or intercurrent HIV infection. By the final vaccination, all subjects in all cohorts had developed antibodies against IHV01; all placebo recipients were negative. The antibodies induced by IHV01 reacted with envelope antigens from diverse HIV-1 strains (Figure 2). Conclusion IHV01 vaccine was safe, well tolerated, and immunogenic in all doses tested. The vaccine raised broadly reactive humoral responses against multiple gp120 domains, transition state structures, and CD4i epitopes. Disclosures All Authors: No reported Disclosures.

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Stringent fluid management might help to prevent postoperative ileus after loop ileostomy closure

Langenbeck s Archives of Surgery ◽

10.1007/s00423-018-1744-4 ◽

2019 ◽

Vol 404 (1) ◽

pp. 39-43 ◽

Cited By ~ 3

Author(s):

Fabian Grass ◽

Basile Pache ◽

Fabio Butti ◽

Josep Solà ◽

Dieter Hahnloser ◽

...

Keyword(s):

Postoperative Ileus ◽

Loop Ileostomy ◽

Fluid Management ◽

Ileostomy Closure

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Efficacy of dexamethasone in reducing the incidence of postoperative sore throat: a double blind randomized study

Journal of Patan Academy of Health Sciences ◽

10.3126/jpahs.v5i1.24034 ◽

2018 ◽

Vol 5 (1) ◽

pp. 10-15 ◽

Cited By ~ 1

Author(s):

Sujita Manandhar ◽

Kishor Manandhar ◽

Sharad Khakrel

Keyword(s):

Endotracheal Tube ◽

Sore Throat ◽

Randomized Study ◽

Saline Group ◽

Controlled Study ◽

Control Group ◽

Lower Grade ◽

Postoperative Sore Throat ◽

Double Blind ◽

Dexamethasone Group

Introductions: Postoperative sore throat (POST) is a commonly seen adverse event after general anesthesia with endotracheal intubation. Dexamethasone, a potent corticosteroid with anti-inflammatory action is the most popular steroid studied in this regard with positive results. Methods: This randomized, prospective, double-blinded, placebo-controlled study was conducted on one hundred and ten adult patients of either sex, American Society of Anesthesiologists physical status I & II, undergoing elective surgeries requiring endotracheal tube intubation. After obtaining written informed consent, they were randomly divided into Control (A, n=55) and Dexamethasone (B, n=55) groups and received either an injection of Dexamethasone (Group B) 8 mg intravenously or an equivalent volume of Normal Saline (Group A) just before entering the operating theatre. All the patients received a similar anesthesia with endotracheal tube intubation and at the end of surgery, extubated and transferred to the post-anesthesia care unit. The incidence and severity of sore throat were assessed at 1, 6 and 24 hours post-extubation. Severity of sore throat were graded on a 4 point scale, p <0.05 was considered significant. Results: Incidence of POST in Dexamethasone group was found significantly low compared to the control group up to six hours (p<0.05) but was comparable at 24 hours post extubation. Severity of POST in the study group was of lower grade in compare to control group. Conclusions: Prophylactic intravenous Dexamethasone 8 mg administered to patients undergoing elective surgeries requiring endotracheal tube intubation significantly reduces the incidence and severity of POST up to six hours post-extubation.

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Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

Thrombosis and Haemostasis ◽

10.1160/th12-03-0188 ◽

2012 ◽

Vol 108 (11) ◽

pp. 913-922 ◽

Cited By ~ 19

Author(s):

Uri Martinowitz ◽

Jerzy Windyga ◽

Giovanni Di Minno ◽

Andrzej Hellmann ◽

Ingrid Pabinger ◽

...

Keyword(s):

Controlled Study ◽

Control Group ◽

Investigational Drug ◽

Haemophilia A ◽

Double Blind ◽

Investigational Treatment ◽

Joint Health ◽

Secondary Endpoints ◽

Recombinant Fviii ◽

Randomised Controlled

SummaryThe benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79–4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79–4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79–4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79–4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79–4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79–4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79–4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

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