This study is aimed to evaluate the promoting effects of vaginal Lactobacillus capsule on microecological reconstruction and mucosal repair of the neovagina after biological graft vaginoplasty in patients with MRKH syndrome, , through a randomized controlled trial (RCT).
Patients diagnosed with MRKH syndrome;
Undergoing initial surgical treatment;
Undergoing biological graft vaginoplasty;
Age: 18-35 years;
History of previous vaginoplasty or other related treatments;
History of diabetes mellitus or systemic immune system diseases;
Concurrent severe medical or surgical diseases that make the patient unable to tolerate drug therapy;
Inability or unwillingness to sign the informed consent form;
Parallel
postoperative application of vaginal Lactobacillus capsule
Biological/VaccineThe patients in intervention group (n=16) will wash the vulva with clean water every night and then insert one Dingjunsheng capsule (0.25 g/capsule, containing Lactobacillus delbrueckii ≥0.25 × 10⁶ CFU/mL; for vaginal use; Lot No.: 20120804; Inner Mongolia Shuangqi Pharmaceutical Co., Ltd.) deep into the vagina once nightly for 10 consecutive days. The methods of disinfecting and wearing the vaginal mold will be the same in both groups.
routine care
Other interventionThe patients in control group (n=16) will wash the vulva with clean water every night without using any medication and wear the vaginal mold. The methods of disinfecting and wearing the vaginal mold will be the same in both groups.
Lactobacillus count
Vaginal secretions were collected for Lactobacillus counting. Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Lactobacillus count
Vaginal secretions were collected for Lactobacillus counting. Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Lactobacillus count
Vaginal secretions were collected for Lactobacillus counting. Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Lactobacillus count
Vaginal secretions were collected for Lactobacillus counting: Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal Lactobacillus count in healthy individuals. (+++) and (++++) are considered effective; (+) and (++) are ineffective.
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
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