Jing-Xin Ding1, Li-mei Chen1, Xu-yin Zhang1, Ying Zhang1, Ke-Qin Hua2. 1. Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai 200011, China. 2. Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China Shanghai Key Laboratory of Female Reproductive Endocrine Related Diseases, Shanghai 200011, China huakeqin@126.com.
Abstract
STUDY QUESTION: Can vaginoplasty in patients with Mayer-Rokitansky-Küster-Hauser syndrome (MRKHS) be achieved using an acellular porcine small intestinal submucosa (SIS) graft? SUMMARY ANSWER: Vaginoplasty using SIS graft was successfully achieved in women with MRKHS, and the anatomical and functional outcomes of this procedure were comparable to those of laparoscopic peritoneal vaginoplasty. WHAT IS KNOWN ALREADY: There is a great variety of vaginal reconstruction techniques, which suggests there is no single superior surgical technique. STUDY DESIGN, SIZE, DURATION: This prospective observational study included 34 patients with congenital vaginal agenesis who underwent vaginoplasty using SIS graft (the SIS group) between December 2011 and July 2013, and 41 patients with the same disease who underwent laparoscopic peritoneal vaginoplasty (the Davydov group) between January 2008 and July 2013. PARTICIPANTS/MATERIALS, SETTING, METHODS: Patient and surgical data, follow-up information, and the female sexual function index (FSFI) scores in the two groups were analysed and compared. MAIN RESULTS AND THE ROLE OF CHANCE: Compared with the laparoscopic Davydov procedure, the operating time of vaginoplasty using SIS graft was significantly shorter, and the estimated blood loss was significantly less. Patients in the SIS group had an earlier return of bowel activity, and an earlier return to work. However, the total cost in the SIS group was significantly higher than that in the Davydov group due to the cost of the SIS graft ($3525 per graft). Most patients (28/34 in the SIS group and 37/41 in the laparoscopic Davydov group) returned for their follow-up 9 months post-surgery. The mean length of the neovagina in the SIS group seemed slightly shorter than that in the Davydov group (6.8 ± 0.9 cm versus 7.3 ± 1.3 cm, P = 0.081). Thirteen patients (46%) in the SIS group and 11 (29%) in the Davydov group had a neovagina <7 cm long (P = 0.453), whereas 4 patients (14%) in the SIS group and 3 patients (8%) in the Davydov group had a neovagina <6 cm long (P = 0.201). Sixteen patients in the SIS group and 25 in the Davydov group subsequently had a sexual partner and became sexually active. Four patients in the SIS group and six in the Davydov group reported low total FSFI scores (≤23). There was no statistically significant difference in the total FSFI scores and the scores of all six domains of the FSFI between the two groups. The average time of continuous mould wearing in the SIS group was statistically significantly longer than that in the Davydov group (7.8 ± 3.3 months versus 4.8 ± 1.6 months, P = 0.001). In the patients with a neovaginal length of ≥6 cm, the FSFI score of the women (26.6 ± 2.3 versus 21.5 ± 1.5, P < 0.001) and the satisfactory score of their partner (8.6 ± 1.2 versus 6.6 ± 1.2, P < 0.001) were both statistically significantly higher than patients with a neovaginal length of <6 cm. LIMITATIONS, REASONS FOR CAUTION: The main limitation of this study is that it is non-randomized. Further randomized studies are warranted to compare the effects of these two procedures. WIDER IMPLICATIONS OF THE FINDINGS: Despite the need to wear a mould for longer, vaginoplasty using SIS graft provides an attractive, alternative treatment for women with MRKHS. STUDY FUNDING/COMPETING INTERESTS: This study was supported by the Chinese National Nature Sciences Foundation (grant number 81471416) and the National Key Clinical Faculty Construction Program of China. No competing interests are declared. TRIAL REGISTRATION NUMBER: N/A.
STUDY QUESTION: Can vaginoplasty in patients with Mayer-Rokitansky-Küster-Hauser syndrome (MRKHS) be achieved using an acellular porcine small intestinal submucosa (SIS) graft? SUMMARY ANSWER: Vaginoplasty using SIS graft was successfully achieved in women with MRKHS, and the anatomical and functional outcomes of this procedure were comparable to those of laparoscopic peritoneal vaginoplasty. WHAT IS KNOWN ALREADY: There is a great variety of vaginal reconstruction techniques, which suggests there is no single superior surgical technique. STUDY DESIGN, SIZE, DURATION: This prospective observational study included 34 patients with congenital vaginal agenesis who underwent vaginoplasty using SIS graft (the SIS group) between December 2011 and July 2013, and 41 patients with the same disease who underwent laparoscopic peritoneal vaginoplasty (the Davydov group) between January 2008 and July 2013. PARTICIPANTS/MATERIALS, SETTING, METHODS:Patient and surgical data, follow-up information, and the female sexual function index (FSFI) scores in the two groups were analysed and compared. MAIN RESULTS AND THE ROLE OF CHANCE: Compared with the laparoscopic Davydov procedure, the operating time of vaginoplasty using SIS graft was significantly shorter, and the estimated blood loss was significantly less. Patients in the SIS group had an earlier return of bowel activity, and an earlier return to work. However, the total cost in the SIS group was significantly higher than that in the Davydov group due to the cost of the SIS graft ($3525 per graft). Most patients (28/34 in the SIS group and 37/41 in the laparoscopic Davydov group) returned for their follow-up 9 months post-surgery. The mean length of the neovagina in the SIS group seemed slightly shorter than that in the Davydov group (6.8 ± 0.9 cm versus 7.3 ± 1.3 cm, P = 0.081). Thirteen patients (46%) in the SIS group and 11 (29%) in the Davydov group had a neovagina <7 cm long (P = 0.453), whereas 4 patients (14%) in the SIS group and 3 patients (8%) in the Davydov group had a neovagina <6 cm long (P = 0.201). Sixteen patients in the SIS group and 25 in the Davydov group subsequently had a sexual partner and became sexually active. Four patients in the SIS group and six in the Davydov group reported low total FSFI scores (≤23). There was no statistically significant difference in the total FSFI scores and the scores of all six domains of the FSFI between the two groups. The average time of continuous mould wearing in the SIS group was statistically significantly longer than that in the Davydov group (7.8 ± 3.3 months versus 4.8 ± 1.6 months, P = 0.001). In the patients with a neovaginal length of ≥6 cm, the FSFI score of the women (26.6 ± 2.3 versus 21.5 ± 1.5, P < 0.001) and the satisfactory score of their partner (8.6 ± 1.2 versus 6.6 ± 1.2, P < 0.001) were both statistically significantly higher than patients with a neovaginal length of <6 cm. LIMITATIONS, REASONS FOR CAUTION: The main limitation of this study is that it is non-randomized. Further randomized studies are warranted to compare the effects of these two procedures. WIDER IMPLICATIONS OF THE FINDINGS: Despite the need to wear a mould for longer, vaginoplasty using SIS graft provides an attractive, alternative treatment for women with MRKHS. STUDY FUNDING/COMPETING INTERESTS: This study was supported by the Chinese National Nature Sciences Foundation (grant number 81471416) and the National Key Clinical Faculty Construction Program of China. No competing interests are declared. TRIAL REGISTRATION NUMBER: N/A.