This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).
The population will include Chinese female patients with advanced apical prolapse (stage II-III) and who are undergoing Sacrospinous Ligament Fixation (SSLF) and Ischial spinous fascia fixation (ISFF) procedure using conventional surgical instruments without special instrument. After enrollment, standardized baseline data including demographics, POPQ evaluation, series of validated questionaires via interviews( PFDI-20, PFIQ-7, PISQ-12) will be collected by study personnel at the baseline visit. Eligible consenting patients will proceed to randomizations with equal probability of assignment to SSLF or ISFF. Randomization to either SSLF or ISFF will take place preoperatively by each clinical site using a random permutated block design. After index surgical intervention, scheduled follow-up will occur at 3, 6, 12, 24 and 36 months after the index surgery. At the follow-up visits, POPQ examination will be performed and an update of current medications, an assessment of new or continuing pelvic floor disorders, adverse events that occurred since the previous evaluation, and an assessment of health care costs. A series of validated instruments will be administered via interviews to including PFDI-20, PFIQ-7, PISQ-12, PGI-C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
2nd Affiliated hospital of Anhui Medical college
Hefei, Anhui, China
RECRUITING1st Affiliated hospital of PLA general hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
rate of surgical success
definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. There is no need of further treatment for prolapse, such as reoperation or pessary.
Time frame: up to 36 months after operation
rate of Postoperative recurrence
definition for postoperative recurrence is symptomatic prolapse above grade II occurred 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. Vaginal swelling sensation, that is answer "yes" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". There is need of further treatment for prolapse, such as reoperation or pessary.
Time frame: from 3 months after operation up to 36 months after operation
visual analogue scales
postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain). VAS result will be reported ranging from 0 to 10, with 0 representing no pain, and 10 representing unbearable severe pain
Time frame: up to 36 months after operation, usuallly within 3 days after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)
Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
Lan Zhu, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Suzhou City Hospital
Suzhou, Jiangsu, China
RECRUITINGShanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTime frame: up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)
Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.
Time frame: up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)
Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
Time frame: up to 36 months after operation
results of postoperative symptomatic improvement using patient global impression of change (PGI-C)
Relief of symptoms using patient global impression of change (PGI-C)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.
Time frame: up to 36 months after operation
intraoperative and post operative complications
using IUGA/ICS joint terminology CTS coding system and dingo system
Time frame: up to 36 months after operation