METHODS: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours.
RESULTS: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up.
CONCLUSIONS: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays.
REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
METHODS: We conducted a study on 34 patients with HRP and randomly assigned the patients to two treatment arm groups (n=17). The formalin group underwent 4% formalin dab and another session 4 weeks later. The irrigation group self-administered daily rectal irrigation at home for 8 weeks and consumed oral metronidazole and ciprofloxacin during the first one week. We measured the patients' symptoms and endoscopic findings before and after total of 8 weeks of treatment in both groups.
RESULTS: Our study showed that HRP patients had reduced per rectal bleeding (p = 0.003) in formalin group, whereas irrigation group showed reduced diarrhoea (p=0.018) and tenesmus (p=0.024) symptoms. The comparison between the two treatment arms showed that irrigation technique was better than formalin technique for tenesmus (p=0.043) symptom only.
CONCLUSION: This novel treatment showed benefit in treating HRP. It could be a new treatment option which is safe and conveniently self-administered at home or used as a combination with other therapies to improve the treatment outcome for HRP.
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OBJECTIVES: To assess the effects of interventions for treating different types of post-extraction bleeding.
SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 24 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 12), MEDLINE Ovid (1946 to 24 January 2018), Embase Ovid (1 May 2015 to 24 January 2018) and CINAHL EBSCO (1937 to 24 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. We searched the reference lists of relevant systematic reviews.
SELECTION CRITERIA: We considered randomised controlled trials (RCTs) that evaluated any intervention for treating PEB, with male or female participants of any age, regardless of type of teeth (anterior or posterior, mandibular or maxillary). Trials could compare one type of intervention with another, with placebo, or with no treatment.
DATA COLLECTION AND ANALYSIS: Three pairs of review authors independently screened search records. We obtained full papers for potentially relevant trials. If data had been extracted, we would have followed the methods described in the Cochrane Handbook for Systematic Reviews of Interventions for the statistical analysis.
MAIN RESULTS: We did not find any randomised controlled trial suitable for inclusion in this review.
AUTHORS' CONCLUSIONS: We were unable to identify any reports of randomised controlled trials that evaluated the effects of different interventions for the treatment of post-extraction bleeding. In view of the lack of reliable evidence on this topic, clinicians must use their clinical experience to determine the most appropriate means of treating this condition, depending on patient-related factors. There is a need for well designed and appropriately conducted clinical trials on this topic, which conform to the CONSORT statement (www.consort-statement.org/).
METHODS: This is a retrospective review of consecutive patients who underwent argon plasma coagulation for haemorrhagic radiation proctitis between January 2003 and December 2013. The patients were followed up using a prospectively maintained database.
RESULTS: Ninety-one patients were included with a mean follow-up of 13.1 months. Majoity (n = 85, 93.4 %) of the patients were female. Mean age at the time of treatment was 58.2 (range 23-87) years old. Majority of the patients (n = 73, 80.2 %) received radiotherapy for gynaecological malignancies followed by colorectal (n = 13, 14.3 %) and urological (n = 5, 5.5 %) malignancies. Mean interval between radiation and proctitis was 13.8 (range 3-40) months. Seventy-nine percent of patients were successfully treated after 1-2 sessions. Seventeen (18.7 %) patients experienced self-limiting early complications, and three (3.3 %) had late complications of rectal stenosis which was managed conservatively. Severity of bleeding during the initial presentation is an independent factor that predicts the number of sessions required for successful haemostasis (p = 0.002).
CONCLUSIONS: Argon plasma coagulation is a reasonable treatment option in patients with haemorrhagic radiation proctitis with good safety profile. Our study suggests that the number of APC sessions required to arrest bleeding correlates with the severity of bleeding on initial presentation.
OBJECTIVES: To assess the effects of interventions for treating different types of post-extraction bleeding.
SEARCH METHODS: We searched the following electronic databases: The Cochrane Oral Health Group Trials Register (to 22 March 2016); The Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 2); MEDLINE via OVID (1946 to 22 March 2016); CINAHL via EBSCO (1937 to 22 March 2016). Due to the ongoing Cochrane project to search EMBASE and add retrieved clinical trials to CENTRAL, we searched only the last 11 months of EMBASE via OVID (1 May 2015 to 22 March 2016). We placed no further restrictions on the language or date of publication. We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov), and the WHO Clinical Trials Registry Platform for ongoing trials (http://apps.who.int/trialsearch/default.aspx). We also checked the reference lists of excluded trials.
SELECTION CRITERIA: We considered randomised controlled trials (RCTs) that evaluated any intervention for treating PEB, with male or female participants of any age, regardless of type of teeth (anterior or posterior, mandibular or maxillary). Trials could compare one type of intervention with another, with placebo, or with no treatment.
DATA COLLECTION AND ANALYSIS: Three pairs of review authors independently screened search records. We obtained full papers for potentially relevant trials. If data had been extracted, we would have followed the methods described in the Cochrane Handbook for Systematic Reviews of Interventions for the statistical analysis.
MAIN RESULTS: We did not find any randomised controlled trial suitable for inclusion in this review.
AUTHORS' CONCLUSIONS: We were unable to identify any reports of randomised controlled trials that evaluated the effects of different interventions for the treatment of post-extraction bleeding. In view of the lack of reliable evidence on this topic, clinicians must use their clinical experience to determine the most appropriate means of treating this condition, depending on patient-related factors. There is a need for well designed and appropriately conducted clinical trials on this topic, which conform to the CONSORT statement (www.consort-statement.org/).