scholarly journals A Prospective Randomized Controlled Trial of AJG522 versus Standard PEG + E as Bowel Preparation for Colonoscopy

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Toshihiko Sagawa ◽  
Ken Sato ◽  
Taku Tomizawa ◽  
Masafumi Mizuide ◽  
Hidetoshi Yasuoka ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Controlled Trial ◽  
Bowel Function ◽  
Liquid Volume ◽  
Randomized Controlled ◽  
Stimulant Laxative ◽  
Bowel Cleansing ◽  
Prospective Randomized Controlled Trial ◽  
Bowel Preparations ◽  
To Receive

Polyethylene glycol- (PEG-) based bowel preparations for colonoscopies are often poorly tolerated due to the large volumes of fluid intake required. We compared low-volume “modified” PEG + ascorbic acid (AJG522) with standard PEG with electrolytes (PEG + E) in addition to a stimulant laxative and an agent to improve bowel function for the bowel cleansing before colonoscopy to evaluate its efficacy, safety, and acceptability. Outpatients scheduled to undergo colonoscopy were randomized to receive either AJG522 or PEG + E. Bowel cleansing conditions were assessed via macroscopic fecal findings by blinded and independent investigators. A survey of the patients’ feedback regarding the preparation was conducted by questionnaire. Successful cleansing was achieved in all cases, except for 4 cases in the PEG + E group, at 3 hours after taking the preparation. The fecal properties were significantly clearer in the AJG522 group than in the PEG + E group at 2 hours after taking each preparationP=0.013. Although the total liquid volume of the bowel preparation was not reduced, the AJG522 preparation could significantly reduce the required volume of the preparationP<0.0001. Moreover, the patients in the AJG522 group had better acceptabilityP=0.010. There were no significant differences in the safety profiles between groups (UMIN000013892).

Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial

Endoscopy ◽  
2017 ◽  
Author(s):  
Yu Bai ◽  
Jun Fang ◽  
Sheng-Bing Zhao ◽  
Dong Wang ◽  
Yan-Qing Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Detection Rate ◽  
Controlled Trial ◽  
Complete Removal ◽  
Adenoma Detection Rate ◽  
Randomized Controlled ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Registration Number

Abstract Background and study aims Ideal bowel preparation for colonoscopy requires complete removal of fluid and foam from the colon. Polyethylene glycol (PEG) is widely used for bowel preparation, with antifoaming agents such as simethicone commonly used in combination with PEG. Data on the effect of simethicone on the adenoma detection rate (ADR) were limited. This study therefore aimed to investigate whether preprocedure simethicone could increase the ADR. Patients and methods This was a prospective, multicenter, endoscopist-blinded randomized controlled trial involving consecutive patients who underwent colonoscopy in six centers in China. Patients were randomly assigned to one of two groups: PEG plus simethicone or PEG alone. The primary outcome was ADR; secondary outcomes were quality of bowel preparation, measured by the Boston bowel preparation scale (BBPS) and bubble scores. Results 583 patients were included. More adenomas were detected in the PEG plus simethicone group than in the PEG alone group (ADR 21.0 % vs. 14.3 %, P = 0.04; advanced ADR 9.0 % vs. 7.0 %, P = 0.38). The mean number of adenomas detected was 2.20 ± 1.36 vs. 1.63 ± 0.89 (P = 0.02). Patients in the PEG plus simethicone group showed better bowel cleansing efficacy: BBPS ≥ 6 in 88.3 % vs. 75.2 % (P < 0.001) and bubble scores of 1.00 ± 1.26 vs. 3.98 ± 2.50 (P < 0.001). Abdominal bloating was reported less frequently in the PEG plus simethicone group (7.8 % vs. 19.7 %, P < 0.001) than in the PEG alone group. Conclusion Combined use of PEG and simethicone is associated with a significantly increased ADR in a Chinese population.Clinical trials registration number: NCT02540239

scholarly journals A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ting-Yang Huang ◽  
Jr-Rung Lin ◽  
Yung-Tai Chung
Keyword(s):  
Randomized Controlled Trial ◽  
Success Rate ◽  
Risk Reduction ◽  
Controlled Trial ◽  
Success Rates ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Nasopharyngeal Airway ◽  
The Right ◽  
To Receive

Abstract Background Nasogastric intubation (NGI) is usually challenging in patients under general anesthesia, with reported success rate at the first attempt to be less than 50%. The aim of this study was to investigate whether a preinstalled nasopharyngeal airway (NPA) in the right nasal passageway can facilitate NGI in anesthetized and intubated patients. Methods A prospective randomized controlled trial including 108 patients scheduled for elective intra-abdominal surgeries requiring a nasogastric tube (NGT) was conducted. Fifty-three patients were randomized to receive NGI through a preinstalled NPA in the right nasal passageway (Group NPA) and 55 patients to receive NGI via the right nostril (Group O). The primary outcomes were success rates of NGI at first attempt, success rates of NGI in accumulative attempts, durations of successful NGI at the first attempt and success rates of NGI for the rescuing methods. The secondary outcomes were bleeding incidence and hemodynamic changes induced by NGI. Results Success rate of NGI at the first attempt was 83.0% in Group NPA compared with 47.3% in Group O [P < 0.001; absolute risk reduction (ARR) = 35.7%, 95% confidence interval (CI) = 19.1–52.4%; relative risk reduction (RRR) = 67.8%] and success rate of NGI in accumulative attempts (two attempts maximum) was 88.7% in Group NPA compared with 63.6% in Group O (P = 0.002; ARR = 25.0%, 95% CI = 9.7–40.4%; RRR = 68.9%). Duration for NGI successful at the first attempt in Group NPA was significantly longer than that in Group O (56.3 vs. 27.1 s; P < 0.001; Mean difference = 29.2 s, 95% CI = 20.0–38.4 s). Neither bleeding incidence nor hemodynamic response is significantly different between the two study groups. Conclusions The study indicates a preinstalled NPA in the right nasal passageway facilitates NGI in anesthetized and intubated patients as an initial NGI method and as a rescuing method for patients undergoing two unsuccessful initial attempts of NGI without a preinstalled NPA. However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt. Trial registration: The study was conducted after receiving approval from Institutional Review Board of Chang Gung Memorial Hospital, Linkou branch, Taiwan (registration number 201800138A3; April 11, 2018), and the clinicaltrials.gov (NCT03697642; Principal Investigator: Ting-Yang Huang; Date of registration: October 4, 2018; https://www.clinicaltrials.gov/NCT03697642).

Prospective, Randomized, Controlled Trial of a Hemostatic Sealant in Children Undergoing Adenotonsillectomy

2007 ◽  
Vol 137 (3) ◽  
pp. 454-458 ◽  
Author(s):  
Stephen H. Jo ◽  
Ronald A. Mathiasen ◽  
Deepak Gurushanthaiah
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Postoperative Morbidity ◽  
Controlled Trial ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pain Medications ◽  
Prospective Randomized Controlled Trial ◽  
Cold Knife ◽  
To Receive

OBJECTIVES: To evaluate the efficacy of Floseal as a hemostatic sealant compared to traditional electrocautery hemostasis after cold knife adenotonsillectomy. STUDY DESIGN: Prospective, randomized, controlled trial of 68 consecutive patients undergoing cold steel adenotonsillectomy. Patients were randomized to receive either Floseal (FS) or electrocautery (EC) for hemostasis. RESULTS: FS patients had shorter operative times than EC patients (16 min vs 31.2 min, P < 0.0001) and less blood loss (49.2 mL vs 70.8 mL, P < 0.05). Four EC patients were crossed over to Floseal when adequate hemostasis could not be achieved in the adenoid bed. No Floseal patients were crossed over. FS patients had significantly less pain on postoperative days two through 11 ( P < 0.05) and less use of narcotic pain medications over the first 10 postoperative days ( P < 0.05). FS patients also had a faster return to regular diet (5.5 days vs 7.9 days, P < 0.01) and activity (5.3 days vs 7.8 days, P < 0.01) as compared to the EC patients. There were no significant complications in either group. CONCLUSIONS: Floseal is safe and efficacious, and decreases postoperative morbidity as compared to electrocautery hemostasis after cold steel adenotonsillectomy. SIGNIFICANCE: This study demonstrates the safety and efficacy of Floseal as a hemostatic method in children undergoing adenotonsillectomy.

scholarly journals A Randomized Controlled Trial Evaluating a Low-Volume PEG Solution Plus Ascorbic Acid versus Standard PEG Solution in Bowel Preparation for Colonoscopy

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Masahiro Tajika ◽  
Tsutomu Tanaka ◽  
Makoto Ishihara ◽  
Nobumasa Mizuno ◽  
Kazuo Hara ◽  
...  
Keyword(s):  
Ascorbic Acid ◽  
Bowel Preparation ◽  
Safety Profile ◽  
Biochemical Parameters ◽  
Controlled Trial ◽  
Patient Acceptability ◽  
Randomized Controlled ◽  
Bowel Cleansing ◽  
Hematological And Biochemical Parameters ◽  
Lavage Solution

Evaluation of polyethylene glycol electrolyte lavage solution containing ascorbic acid (PEG-ASC) has been controversial in the point of its hyperosmolarity, especially in old population. So we therefore designed the present study to compare the efficacy, acceptability, tolerability, and safety of 1.5 L PEG+ASC and 2 L standard PEG electrolyte solution (PEG-ELS), not only in the general population, but also in patients of advanced age. Randomization was stratified by age (<70 years or 70> years), and hematological and biochemical parameters were compared in each age group, especially with respect to the safety profile of each regimen. As a result, the 1.5-L PEG-ASC regimen had higher patient acceptability than the 2-L PEG-ELS regimen. Tolerability, bowel cleansing, and safety were similar between regimens. However, we demonstrated significant statistical changes in the hematological and biochemical parameters after taking bowel preparation solutions, not only in the PEG+ASC group, but also in the PEG-ELS group. No significant differences in the safety profile were found between subjects aged less than 70 years and those aged 70 years or more; nevertheless, regardless of age, proper hydration is needed throughout the bowel preparation process.

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