scholarly journals Effect of Diluted Vasopressin vs Saline on Intraoperative Blood Loss during Vaginal Hysterectomy- A Randomised Controlled Trial

2021 ◽  
Author(s):  
Vinika Nimodia ◽  
Sandhya Jain ◽  
Shalini Rajaram ◽  
Asha Tyagi ◽  
Bindiya Gupta
Keyword(s):  
Randomised Controlled Trial ◽  
Blood Transfusion ◽  
Blood Loss ◽  
Vaginal Hysterectomy ◽  
Controlled Trial ◽  
Saline Group ◽  
P Value ◽  
Intraoperative Blood Loss ◽  
Group I ◽  
Randomised Controlled

Introduction: Vasopressin has been used to control blood loss in gynaecological surgeries such as in myomectomy, abdominal hysterectomy etc. Only few studies have demonstrated its efficacy in Vaginal Hysterectomy (VH) in reducing intraoperative blood loss. VH is frequently performed gynaecological surgery in safe lower dose of vasopressin. There is no consensus on dose of infiltration. Aim: To compare submucosal vasopressin vs saline infiltration during VH and assess surgical parameters i.e., intraoperative blood loss, postinfiltration vitals, ease of dissection, use of electrocautery, need of blood transfusion and complications. Materials and Methods: This randomised controlled trial was done in department of Obstetrics and Gynaecology in collaboration with Department of Anaesthesia from November 2017 to April 2019. Low risk women aged <65 years with Pelvic Organ Prolapse Quantification-Stage (POP-Q stage) III/IV prolapse were recruited from Outpatient Department (OPD). They were randomised into two groups. Group I (n=35) patients received submucosal infiltration with diluted vasopressin (40mL vasopressin of 0.1U/mL, total 4U), prior to the incision. Group II (n=35) patients received 40cc of normal saline. Vitals were checked at one and five minutes postinfiltration. All the qualitative parameters were compared between the two groups by chi-square test and quantitative parameters by unpaired t-test. Inter and intragroup comparison was done by Repetitive Measure ANOVA followed by Tukey’s test. For the parameters, which did not follow the Gaussian distribution, were compared by non-parametric Mann-Whitney test between the two groups. A p-value <0.05 was considered as significant. All the data analysis was carried out in Statistical Package for the Social Sciences (SPSS) version 20.0. Results: The mean estimated blood loss from incision till creation of flaps was half in vasopressin group as compared to saline group (21.33 mL vs 49.67 mL, p-value=0.001). Vasopressin group had less use of electrocautery, whereas ease of dissection was more in saline group. There was no significant difference in duration of surgery till flap creation and need of blood transfusion. There was fall in pulse rate and Blood Pressure (BP) in both groups which did not require medical intervention and was likely due to neuraxial anaesthesia. Conclusion: Vasopressin appears to be safe and effective in VH at infiltration dose of four units in dilution. However further studies on larger sample size are recommended to gather more evidence in this regard.

scholarly journals Effects of the use of preoperative GnRHa analogue and intra-operative mechanical tourniquet for myomectomy on surgical blood loss: A randomised controlled trial

2021 ◽  
Author(s):  
Salwa Abdullahi Idle ◽  
Helen Coles ◽  
Salma Ayis ◽  
Nitish Narvekar
Keyword(s):  
Randomised Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Gnrh Analogue ◽  
Intraoperative Blood Loss ◽  
Operative Blood Loss ◽  
Releasing Hormone ◽  
Significant Difference ◽  
Gonadotrophin Releasing Hormone ◽  
Randomised Controlled

Objective To compare the pre-operative use of GnRH analogue and/or intra-operative use of tourniquets to determine which intervention best reduces the intraoperative blood loss at open myomectomy. Design Randomised controlled trial, partially blinded (clinician and participant) Setting Single tertiary centre Population Women requiring open myomectomy in our gynaecology outpatient clinic Methods Patients were allocated to receive either pre-operative GnRHa, intra-operative mechanical tourniquet or a combination of preoperative GnRHa and intra-operative mechanical tourniquet. Main Outcome Measure Mean intraoperative blood loss Results There was a difference in mean intra-operative blood loss of groups GnRHa (n=14) versus Tourniquet (n=12) (752ml, 95% CI 148ml-1355ml, p=0.01) and groups GnRHa versus GnRHa+ Tourniquet (n=17) (804ml, 95% CI 250ml-1357ml, p=0.002). No significant difference in intra-operative blood loss between groups Tourniquet and GnRHa+ Tourniquet (52ml, 95% CI -630ml-526ml, p=1) were detected. A sub-analysis showed that there is no statistical significance (p=0.45) between mean blood loss at surgery and uterine size across the groups. Conclusions The use of a mechanical tourniquet with or without pre-operative gonadotrophin releasing hormone analogues is significantly more effective at reducing intraoperative blood loss at open myomectomy than the use of pre-operative gonadotrophin releasing hormone analogues alone Tweetable Abstract Mechanical tourniquet with or without GnRHa significantly reduces intraoperative blood loss at open myomectomy EudraCT Number 2010-019810-26

scholarly journals Pre-Operative Oral Iron Supplementation Reduces Blood Transfusion in Colorectal Surgery – A Prospective, Randomised, Controlled Trial

2007 ◽  
Vol 89 (4) ◽  
pp. 418-421 ◽  
Author(s):  
PG Lidder ◽  
G Sanders ◽  
E Whitehead ◽  
WJ Douie ◽  
N Mellor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Colorectal Surgery ◽  
Blood Transfusion ◽  
Blood Loss ◽  
Controlled Trial ◽  
Ferrous Sulphate ◽  
Haemoglobin Concentration ◽  
Treated Group ◽  
Operative Blood Loss ◽  
Randomised Controlled

INTRODUCTION Allogeneic blood transfusion confers a risk to the recipient. Recent trials in colorectal surgery have shown that the most significant factors predicting blood transfusion are pre-operative haemoglobin, operative blood loss and presence of a transfusion protocol. We report a randomised, controlled trial of oral ferrous sulphate 200 mg TDS for 2 weeks' pre-operatively versus no iron therapy. PATIENTS AND METHODS Patients diagnosed with colorectal cancer were recruited from out-patient clinic and haematological parameters assessed. Randomisation was co-ordinated via a telephone randomisation centre. RESULTS Of the 49 patients recruited, 45 underwent colorectal resection. There were no differences between those patients not receiving iron (n = 23) and the iron-supplemented group (n = 22) for haemoglobin at recruitment, operative blood loss, operation duration or length of hospital stay. At admission to hospital, the iron-supplemented group had a higher haemoglobin than the non-iron treated group (mean haemoglobin concentration 13.1 g/dl [range, 9.6–17 g/dl] versus 11.8 g/dl [range, 7.8–14.7 g/dl]; P = 0.040; 95% CI 0.26–0.97) and were less likely to require operative blood transfusion (mean 0 U [range, 0–4 U] versus 2 U [range, 0–11 U] transfused; P = 0.031; 95% CI 0.13–2.59). This represented a cost reduction of 66% (47 U of blood = £4700 versus oral FeSO4 at £30 + 15 U blood at £1500). At admission, ferritin in the iron-treated group had risen significantly from 40 μg/l (range, 15–222 μg/l) to 73 μg/l (range, 27–386 μg/l; P = 0.0036; 95% CI 46.53–10.57). CONCLUSIONS Oral ferrous sulphate given pre-operatively in patients undergoing colorectal surgery offers a simple, inexpensive method of reducing blood transfusions.

scholarly journals Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

2019 ◽  
Vol 26 (5) ◽  
pp. 432-438 ◽  
Author(s):  
Alexandra B Hall ◽  
Catherine Ho ◽  
Bianca Albanese ◽  
Lisa Keay ◽  
Kate Hunter ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Instructional Materials ◽  
Control Group ◽  
P Value ◽  
Point Increase ◽  
Comprehension Score ◽  
Child Restraint ◽  
Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

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