Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117670
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-10-31
Brief Title:
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
Official Title:
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy A Pilot One Arm Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
None
Brief Summary:
The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects The main question it aims to answer is
Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective
Participants will undergo posterior colporrhaphy which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair
Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective
Participants will undergo posterior colporrhaphy which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair
Detailed Description:
Methodology
1 Protocol approval will be sought from the research ethical committee
2 Enrolment The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital ASUMH
3 History examination and routine investigations will be done to identify eligible patients
History taking including personal history age menopausal medical history and surgical history as well as symptoms score using Pelvic Organ Prolapse Distress Inventory 6 POPDI-6 part of the Pelvic Floor Distress Inventory Short Form 20 Also sexual function will be assessed by Female Sexual Function Index Questionnaire
Clinical examination including general examination abdominal examination and pelvic examination and POP-Q
Routine investigations complete blood count and other preoperative tests as needed
4 Written informed consent will be sought from the patients after proper counseling
5 Surgical procedure
Posterior colporrhaphy with application of the amniotic membrane graft will be done as follows
Steps of conventional posterior colporrhaphy
A midline incision is extended from the perineal body to the vaginal apex or to the cephalad border of a small or distal rectocele
The Denonvilliers fascia is mobilized from the vaginal epithelium leaving as much of the tissue as possible attached laterally to the levator fascia
Gamma irradiated Sterilized freeze-dried lyophilized amnion grafts will be obtained from the Egyptian Atomic Energy Authority and prepared according to the method of Antounians 2019 Multiple procedures are used to sterilize acellular amniotic membranes the final of which being gamma irradiation For tissue allograft sterilisation gamma radiation is claimed to be the most reliable and successful method Many tissue banks have employed it to sterilise tissues The clinical function of the amniotic membrane is unaffected by gamma radiation 11 The most frequent dose for sterilising medical goods is 25 kilogram This graft has the advantage of complete sterilization and is valid on shelf for 5 years as it is dried Posterior vaginal wall amniotic membrane graft can be placed on the posterior vaginal wall between the rectal fascia and the vagina anchored distally at the uterosacral ligaments and dorsally at the levator ani muscle The excess amniotic membrane graft is trimmed off usually around 1-2 cm on each side
After obvious defects in the rectal muscularis are repaired the fascia is plicated in the midline with interrupted or continuous sutures using vicryl 0 sutures
When a defective perineal body or perineal membrane is present reconstruction is performed after accompanying posterior colporrhaphy
The superficial muscles of the perineum and bulbocavernous fascia are plicated in the midline and the skin closed as in an episiotomy repair using vicryl 20 sutures
Detachments of the inferior portion of the Denonvilliers fascia from the perineal body are also corrected
Postoperative instructions and care
Vaginal pack will be left as a compression and will be removed the following day
Urinary catheter will be left for 24hours then removed
Postoperative clinical assessment by POP-Q
Patients will be instructed to
Mobilize to reduce risk of deep vein thrombosis
Bath or shower as normal routine
Avoid using tampons for 6 weeks
Avoid sexual intercourse for at least 6weeks
Avoid constipation by drinking plenty of water and fluids eating fruit and green vegetables and any constant cough is to be treated promptly
Avoid heavy lifting to reduce the risk of the prolapse recurrence
6 Follow up schedule
Follow up of all patients will be done in both groups at 3 and 6 months symptoms - examination as needed
7 Data collection and recording Data will be collected and recorded in case report form Detection bias will be avoided by blinding the outcome assessor
8 Statistical analysis will be done to get the results
1 Protocol approval will be sought from the research ethical committee
2 Enrolment The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital ASUMH
3 History examination and routine investigations will be done to identify eligible patients
History taking including personal history age menopausal medical history and surgical history as well as symptoms score using Pelvic Organ Prolapse Distress Inventory 6 POPDI-6 part of the Pelvic Floor Distress Inventory Short Form 20 Also sexual function will be assessed by Female Sexual Function Index Questionnaire
Clinical examination including general examination abdominal examination and pelvic examination and POP-Q
Routine investigations complete blood count and other preoperative tests as needed
4 Written informed consent will be sought from the patients after proper counseling
5 Surgical procedure
Posterior colporrhaphy with application of the amniotic membrane graft will be done as follows
Steps of conventional posterior colporrhaphy
A midline incision is extended from the perineal body to the vaginal apex or to the cephalad border of a small or distal rectocele
The Denonvilliers fascia is mobilized from the vaginal epithelium leaving as much of the tissue as possible attached laterally to the levator fascia
Gamma irradiated Sterilized freeze-dried lyophilized amnion grafts will be obtained from the Egyptian Atomic Energy Authority and prepared according to the method of Antounians 2019 Multiple procedures are used to sterilize acellular amniotic membranes the final of which being gamma irradiation For tissue allograft sterilisation gamma radiation is claimed to be the most reliable and successful method Many tissue banks have employed it to sterilise tissues The clinical function of the amniotic membrane is unaffected by gamma radiation 11 The most frequent dose for sterilising medical goods is 25 kilogram This graft has the advantage of complete sterilization and is valid on shelf for 5 years as it is dried Posterior vaginal wall amniotic membrane graft can be placed on the posterior vaginal wall between the rectal fascia and the vagina anchored distally at the uterosacral ligaments and dorsally at the levator ani muscle The excess amniotic membrane graft is trimmed off usually around 1-2 cm on each side
After obvious defects in the rectal muscularis are repaired the fascia is plicated in the midline with interrupted or continuous sutures using vicryl 0 sutures
When a defective perineal body or perineal membrane is present reconstruction is performed after accompanying posterior colporrhaphy
The superficial muscles of the perineum and bulbocavernous fascia are plicated in the midline and the skin closed as in an episiotomy repair using vicryl 20 sutures
Detachments of the inferior portion of the Denonvilliers fascia from the perineal body are also corrected
Postoperative instructions and care
Vaginal pack will be left as a compression and will be removed the following day
Urinary catheter will be left for 24hours then removed
Postoperative clinical assessment by POP-Q
Patients will be instructed to
Mobilize to reduce risk of deep vein thrombosis
Bath or shower as normal routine
Avoid using tampons for 6 weeks
Avoid sexual intercourse for at least 6weeks
Avoid constipation by drinking plenty of water and fluids eating fruit and green vegetables and any constant cough is to be treated promptly
Avoid heavy lifting to reduce the risk of the prolapse recurrence
6 Follow up schedule
Follow up of all patients will be done in both groups at 3 and 6 months symptoms - examination as needed
7 Data collection and recording Data will be collected and recorded in case report form Detection bias will be avoided by blinding the outcome assessor
8 Statistical analysis will be done to get the results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None