ResearchPad - randomized-clinical-trial https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Retrograde inspection <i>vs</i> standard forward view for the detection of colorectal adenomas during colonoscopy: A back-to-back randomized clinical trial]]> https://www.researchpad.co/article/Nf562d4f0-fe11-4a99-9b27-59cedefeda6c The adenoma detection rate (ADR) is inversely associated with the incidence of interval colorectal cancer and serves as a benchmark quality criterion during screening colonoscopy. However, adenoma miss rates reach up to 26% and studies have shown that a second inspection of the right colon in retroflected view (RFV) can increase ADR.AIMTo assess whether inspection of the whole colon in RFV compared to standard forward view (SFV) can increase ADR.METHODSPatients presenting for screening or surveillance colonoscopy were invited to participate in this randomized controlled trial and randomized into two arms. In RFV arm colonoscopy was initially performed with SFV, followed by a second inspection of the whole colon in RFV. In the SFV arm first withdrawal was performed with SFV, followed by a second inspection of the whole colon again with SFV. Number, size and morphology of polyps found during first and second inspection in each colonic segment were recorded and all polyps were removed and sent for histopathology in separate containers.RESULTSTwo hundred and five patients were randomly assigned to the RFV (n = 101) and SFV (n = 104) arm. In the RFV arm, both polyp detection rate (PDR) and ADR were increased under second inspection in RFV (PDR 1st SFV: 39.8%, PDR 2nd RFV: 46.6%; ADR 1st SFV: 35.2%, ADR 2nd RFV: 42%). Likewise, in the SFV arm, PDR and ADR were increased under second inspection (PDR 1st SFV: 37.5%, PDR 2nd SFV: 46.6%; ADR 1st SFV: 34.1%, ADR 2nd SFV: 44.3%) with no significant differences in ADR and PDR between the SFV and RFV arm. Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1st SFV: 1.71; 2nd RFV: 2.38; APP SFV arm: 1st SFV: 1.83, 2nd SFV:2.2). The majority of adenomas additionally found during second inspection in RFV or in SFV were located in the transverse and left-sided colon and were > 5 mm in size.CONCLUSIONSecond inspection of the whole colon leads to increased adenoma detection with no differences between SFV and RFV. Hence, increased detection is most likely a feature of the second inspection itself but not of the inspection mode. ]]> <![CDATA[Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial]]> https://www.researchpad.co/article/N0c45a190-1ecc-40c0-95c2-561fa05c6b26

Background

Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding.

Methods

This was a two‐centre, stratified, parallel‐group, placebo‐controlled, double‐blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1 : 1 to moistening of wound surface before closure with either 25 mg/ml TXA or 0·9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24 h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3 months.

Results

Between 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089).

Conclusion

Moistening the wound with TXA 25 mg/ml before closure reduces postoperative bleeding within the first 24 h in patients undergoing mastectomy. Registration number: NCT02627560 (https://clinicaltrials.gov).

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<![CDATA[Dialkylcarbamoyl chloride‐coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study)]]> https://www.researchpad.co/article/N897cff3c-ae05-43e4-846d-7bcdd46fb6bc

Background

Disease of the pilonidal sinus is a common condition that affects mainly young adults. Options for management include excision of the sinus tracts, leaving the wound open to heal by secondary intention. The aim of this study was to compare wound healing with dialkylcarbamoyl chloride (DACC)‐coated dressings versus alginate dressings.

Methods

This multicentre trial randomized consecutive patients undergoing surgery for pilonidal disease to postoperative wound care with either DACC‐coated or alginate dressings. The primary outcome was the proportion of wounds healed after 75 days. Secondary outcomes were the local status of wounds during the healing process, the quality assessment of the dressings by the patient, and the time needed to return to usual activities.

Results

A total of 246 patients were included: 120 in the DACC‐coated group and 126 in the alginate group. In per‐protocol analysis, there were significantly more patients with completely healed wounds after 75 days in the DACC group than in the alginate group: 78 of 103 (75·7 per cent) versus 58 of 97 (60 per cent) respectively (odds ratio 2·55, 95 per cent c.i. 1·12 to 5·92; P = 0·023). During follow‐up, wounds with alginate dressings had more fibrin than those with DACC‐coated dressings, but the difference was not significant (P = 0·079). There was no difference between the two arms in patients' assessment of the dressings.

Conclusion

The number of wounds completely healed at 75 days was significantly higher for DACC‐coated compared with alginate dressings. However, the preplanned, clinically significant improvement in healing of 20 per cent was not reached. Registration number: NCT02011802 ( https://clinicaltrials.gov/).

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<![CDATA[Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection]]> https://www.researchpad.co/article/N9a02081b-a3fe-4873-889e-f784d99685f1

Background

Animal studies have shown that peritoneal injury can be minimized by insufflating the abdominal cavity with warm humidified carbon dioxide gas.

Methods

A single‐blind RCT was performed at a tertiary colorectal unit. Inclusion criteria were patient aged 18 years and over undergoing open elective surgery. The intervention group received warmed (37°C), humidified (98 per cent relative humidity) carbon dioxide (WHCO2 group). Multiple markers of peritoneal inflammation and oxidative damage were used to compare groups, including cytokines and chemokines, apoptosis, the 3‐chlorotyrosine/native tyrosine ratio, and light microscopy on peritoneal biopsies at the start (T0) and end (Tend) of the operation. Postoperative clinical outcomes were compared between the groups.

Results

Of 40 patients enrolled, 20 in the WHCO2 group and 19 in the control group were available for analysis. A significant log(Tend/T0) difference between control and WHCO2 groups was documented for interleukin (IL) 2 (5·3 versus 2·8 respectively; P = 0·028) and IL‐4 (3·5 versus 2·0; P = 0·041), whereas apoptosis assays documented no significant change in caspase activity, and similar apoptosis rates were documented along the peritoneal edge in both groups. The 3‐chlorotyrosine/tyrosine ratio had increased at Tend by 1·1‐fold in the WHCO2 group and by 3·1‐fold in the control group. Under light microscopy, peritoneum was visible in 11 of 19 samples from the control group and in 19 of 20 samples from the WHCO2 group (P = 0·006). The only difference in clinical outcomes between intervention and control groups was the number of days to passage of flatus (2·5 versus 5·0 days respectively; P = 0·008).

Conclusion

The use of warmed, humidified carbon dioxide appears to reduce some markers related to peritoneal oxidative damage during laparotomy. No difference was observed in clinical outcomes, but the study was underpowered for analysis of surgical results. Registration number: NCT02975947 ( http://www.clinicaltrials.gov/).

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<![CDATA[Adjuvant statin therapy for oesophageal adenocarcinoma: the STAT‐ROC feasibility study]]> https://www.researchpad.co/article/Nf3b85b4a-3f75-4404-bd07-720fad428bdb

Background

Statins inhibit proliferative signalling in oesophageal adenocarcinoma (OAC) and their use is associated with better survival in observational studies. The present study was undertaken to examine the feasibility of assessing adjuvant statin therapy in patients with operable OAC in a phase III RCT.

Methods

For this multicentre, double‐blind, parallel‐group, randomized, placebo‐controlled feasibility trial, adults with OAC (including Siewert I–II lesions) who had undergone oesophagectomy were centrally allocated (1 : 1) to simvastatin 40 mg or matching placebo by block randomization, stratified by centre. Participants, clinicians and investigators were blinded to treatment allocation. Patients received treatment for up to 1 year. Feasibility outcomes were recruitment, retention, drug absorption, adherence, safety, quality of life, generalizability and survival.

Results

A total of 120 patients were assessed for eligibility at four centres, of whom 32 (26·7 per cent) were randomized, 16 in each group. Seven patients withdrew. Participants allocated to simvastatin had lower low‐density lipoprotein cholesterol levels by 3 months (adjusted mean difference −0·83 (95 per cent c.i. −1·4 to −0·22) mmol/l; P = 0·009). Median adherence to medication was greater than 90 per cent between 3 and 12 months' follow‐up. Adverse events were similar between the groups. Quality‐of‐life data were complete for 98·3 per cent of questionnaire items. Cardiovascular disease, diabetes and aspirin use were more prevalent in the non‐randomized group, whereas tumour site, stage and grade were similar between groups. Survival estimates were imprecise.

Conclusion

This RCT supports the conduct and informs the design considerations for a future phase III trial of adjuvant statin therapy in patients with OAC. Registration number: ISRCTN98060456 (http://www.isrctn/com).

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<![CDATA[Regular consumption of Lactobacillus reuteri‐containing lozenges reduces pregnancy gingivitis: an RCT ]]> https://www.researchpad.co/article/5c33d13fd5eed0c4845d9f47

Abstract

Aim

This randomized controlled trial assessed the impact of Lactobacillus reuteri on pregnancy gingivitis in healthy women.

Materials and Methods

Forty‐five healthy women (24 test/21 placebo) with pregnancy gingivitis in the third trimester of pregnancy were enrolled. At baseline Gingival Index (GI) and Plaque Index (PlI) were assessed at the Ramfjord teeth and venous blood taken for TNFα analysis. Subsequently participants were randomly provided with lozenges to be consumed 2 × daily until birth (approx. 7 weeks) containing ≥108 CFU L. reuteri ATCC PTA 5289 and ≥108 CFU L. reuteri DSM 17938 (test) or being devoid of L. reuteri (placebo). Within 2 days after birth recording of GI, PlI and blood sampling were repeated.

Results

At baseline, mean GI and mean PlI did not differ significantly between both groups. In the test group mean TNFα serum level was significantly (p < 0.02) lower than in the placebo group. At reevaluation, mean GI and mean PlI of the test group were both significantly (p < 0.0001) lower than in the placebo group. Mean TNFα serum level did no longer differ significantly between the groups.

Conclusions

The consumption of L. reuteri lozenges may be a useful adjunct in the control of pregnancy gingivitis.

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<![CDATA[Efficacy of combination therapy with natriuretic and aquaretic drugs in cirrhotic ascites patients: A randomized study]]> https://www.researchpad.co/article/5b46ae06463d7e62a95cbece

AIM

To assess the effects of a combination therapy with natriuretic and aquaretic drugs in cirrhotic ascites patients.

METHODS

A two-center, randomized, open-label, prospective study was conducted. Japanese patients who met the criteria were randomized to trial group and the combination diuretic group (received 7.5 mg of tolvaptan) or the conventional diuretic group (received 40 mg of furosemide) for 7 d in addition to the natriuretic drug which was used prior to enrolment in this study. The primary endpoint was the change in body weight from the baseline. Vital signs, fluid intake, and laboratory and urinary data were assessed to determine the pharmacological effects after administration of aquaretic and natriuretic drugs.

RESULTS

A total of 56 patients were randomized to receive either tolvaptan (n = 28) or furosemide (n = 28). In the combination and conventional diuretic groups, the average decrease in body weight from the baseline was 3.21 ± 3.17 kg (P < 0.0001) and 1.75 ± 2.36 kg (P = 0.0006), respectively, when measured on the final dosing day. Following 1 wk of treatment, a significantly greater reduction in body weight was observed in the combination diuretic group compared to that in the conventional diuretic group (P = 0.0412).

CONCLUSION

Compared to a conventional diuretic therapy with only a natriuretic drug, a combination diuretic therapy with natriuretic and aquaretic drugs is more effective for patients with cirrhotic ascites.

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