Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02808377
Status:
UNKNOWN
Last Update Posted:
2016-06-21
First Post:
2016-06-07
Brief Title:
Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY SPOP A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTRSPOP
Brief Summary:
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6 12 24 months in two arms One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not
Detailed Description:
Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic About one in ten women in the developed world will require surgery for prolapse in their lifetime The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result
In this study a soft silicone support SPOP is inserted into the vagina straight after prolapse surgery Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery There will be 120 patients in the study so 60 women will have the SPOP inserted
The investigators think that SPOP will support the vagina as it heals improving the results of surgery There are already some studies of the SPOP with other surgeries that show improved results The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery It is attached with two dissolving stiches to the vagina After four weeks is will be removed in the out patient clinic without any discomfort It is not usually painful or uncomfortable at any time
The actual surgery the women have will not be any different had they not been in the study All the women in the study will have the normal assessment prior to their operation and will fill out some questionnaires about their symptoms too All women involved in the study will come back the clinic to be seen after six months one year and two years from the date of the surgery This is regardless of whether they had the SPOP or not When the women return they will be examined and complete the questionnaires again each visit
The results of the study will be reported and published
In this study a soft silicone support SPOP is inserted into the vagina straight after prolapse surgery Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery There will be 120 patients in the study so 60 women will have the SPOP inserted
The investigators think that SPOP will support the vagina as it heals improving the results of surgery There are already some studies of the SPOP with other surgeries that show improved results The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery It is attached with two dissolving stiches to the vagina After four weeks is will be removed in the out patient clinic without any discomfort It is not usually painful or uncomfortable at any time
The actual surgery the women have will not be any different had they not been in the study All the women in the study will have the normal assessment prior to their operation and will fill out some questionnaires about their symptoms too All women involved in the study will come back the clinic to be seen after six months one year and two years from the date of the surgery This is regardless of whether they had the SPOP or not When the women return they will be examined and complete the questionnaires again each visit
The results of the study will be reported and published
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None