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A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. We hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and we hypothesize that a reduction to 25% is possible in the experimental group.
The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.
special tampon with a diameter of 28mm, standard tampon with a diameter of 12-13mm
Not yet recruiting
University Hospital Heidelberg
Published on BioPortfolio: 2019-09-24T05:27:33-0400
This study will evaluate the impact on vaginal health of four different tampons using gynecologic assessment and subjective assessment of comfort during in-use conditions
The vaginal microbiota is the community of bacteria in the vagina. The composition of the vaginal microbiota (which bacteria are present and how many of each are present) is known to affec...
The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses. Study Hypothesis: Expression of HPV E6/E7 mRN...
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condi...
The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home. Study hypothesis: The tampon self-tes...
The aim of this study was to assess the efficacy of an iodine tampon after mandibular third molar surgery on oral health-related quality of life (OHRQoL), use of painkillers, postoperative sequelae, a...
Anterior epistaxis is commonly treated with Merocel nasal packing insertion. A 63-year-old male patient showed a cerebrospinal fluid rhinorrhea and pneumocephalus immediately after insertion of a Mero...
There is dearth of studies assessing clinical, restorative, and radiographic peri-implant outcomes around narrow diameter implants (NDIs) and standard diameter implants (SDIs) in obese and nonobese su...
We assessed the interference between vaginal ring use and menses among women who participated in the qualitative component of the MTN-020/ASPIRE vaginal ring trial in Malawi, South Africa, Uganda and ...
To compare the longevity and marginal bone loss of narrow-diameter (≤3.3-mm) versus standard-diameter implants supporting single crowns.
A method of stopping internal bleeding or blood flow, or the closure of a wound or body cavity, achieved by applying pressure or introducing an absorbent liquid, gel, or tampon.
Collections covering specialized subjects, containing materials in a special format, or serving a specialized clientele.
Education of the individual who markedly deviates intellectually, physically, socially, or emotionally from those considered to be normal, thus requiring special instruction.
A subgroup having special characteristics within a larger group, often bound together by special ties which distinguish it from the larger group.
Travel by a group of physicians to a foreign country for the purpose of making a special study or of undertaking a special project of a short-term duration; not to be confused with MISSIONS AND MISSIONARIES which covers permanent medical establishments and personnel maintained by religious organizations.
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...