RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

Apical Prolapse Clinical Trial

Official title:

Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213027
• Other study ID #: PekingUMCH SSLFvsISFF-CSI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: Yuxin Dai, MD
• Phone: 0086-010-69156204
• Email: helen81918[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)

2. SSLF or ISFF is proceeded as described before,while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.

3. Women who have been eligible for long-term follow-up.

4. Women who agreed to participate in the study and signed informed consent.

Exclusion Criteria:

1. Women who have surgical history for prolapse with mesh.

2. Women who have contraindication for surgical procedure

3. Women who are unable to comply with the study procedures

Related Conditions & MeSH terms

• Apical Prolapse
• Prolapse

Intervention

Procedure:
• native tissue repair procedures with conventional surgical instruments
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).

Locations

Country	Name	City	State
China	1st Affiliated hospital of PLA general hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	2nd Affiliated hospital of Anhui Medical college	Hefei	Anhui
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai
China	Suzhou City Hospital	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review. — View Citation

Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Develo — View Citation

Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014. — View Citation

Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage ?-? pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese. — View Citation

Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 36 months after operation
Secondary	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.	from 3 months after operation up to 36 months after operation
Secondary	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	up to 36 months after operation, usuallly within 3 days after operation
Secondary	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.	up to 36 months after operation
Secondary	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.	up to 36 months after operation
Secondary	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.	up to 36 months after operation
Secondary	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.	up to 36 months after operation
Secondary	intraoperative and post operative complications	using IUGA/ICS joint terminology CTS coding system and dingo system	up to 36 months after operation