Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05668130 |
| Other study ID # |
394/079/080-IRC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2023 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
January 2023 |
| Source |
B.P. Koirala Institute of Health Sciences |
| Contact |
Tulasa Basnet, MD |
| Phone |
9779842158761 |
| Email |
tulasabasnet29[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the main aim of this study is to study the anatomical and functional outcomes of two vaginal
apical fixation procedures; sacrospinous ligament fixation and uterosacral ligament
suspension, for pelvic organ prolapse surgery.
The participants will be randomized to either of the surgical procedure and will be followed
up for one year to study the outcome.
Description:
1. Objectives General objective To compare the surgical outcome between SSLF and modified
USLS for apical fixation in women undergoing vaginal prolapse surgery Specific
objectives 1) To compare the success rate of SSLF and modified USLS for apical fixation
at 6 month and one year after vaginal prolapse surgery 2) To evaluate perioperative
complications of the two procedures 3) To study the change in pelvic floor disorders
symptoms in postoperative period ( 6 months and 12 months) among two groups.
2. Methods 2.1. Recruitment: Women with stage II or higher POP with involvement of apical
compartment planned for surgical management will be included in the study. Detailed
history will be taken regarding demographic profile like age, parity, menopausal status,
mode of previous deliveries, history of smoking, heavy weight lifting. The presenting
complaints as well as other associated complaints will be noted. History of previous
abdominal or pelvic surgeries will be obtained. For recording the history regarding
pelvic floor disorders, PFDI 20 (translated in Nepali language and pretested) will be
used. General and systemic physical examination will be performed. The BMI will be
noted. The prolapse will be examined and staged according to POP-Q staging system. Cough
stress test and ESST will be performed to rule out SUI. The tests will be performed
after reducing the prolapse to rule out occult SUI. The intended prolapse surgery as
well as necessary concomitant surgeries will be decided by the surgeon. Informed written
consent will be obtained from the participants for including into the trial.
2.2. Randomization: The participants will be randomized on 1:1 basis to one of the methods of
vaginal apical suspension either SSLF or USLS. Computer generated randomization table will be
generated and used for randomization. The patients will be randomized by one of the residents
posted in unit who is not involved in the research one day prior to surgery after
pre-operative examination and decision for surgery is made.
2.3 Surgical procedures The surgeries will be performed by a team of surgeons with technical
competency in both the techniques.
Method of Sacrospinous Ligament Fixation (SSLF):
Women who are randomized to this group will undergo unilateral sacrospinous ligament
fixation. For all the women with uterine descent requiring the hysterectomy, vaginal
hysterectomy will be performed using standard method. In women with vault prolapse, the apex
of the vagina is grasped with Allis forceps. A horizontal incision is given in the apex over
previous scar of vaginal vault. The enterocele sac will be dissected off the vaginal mucosa.
The sacrospinous ligament will be accessed via posterior approach. A vertical incision will
be given in the posterior vaginal wall leaving ~2-3 cm bridge of vaginal mucosa between the
incision and the vault. The right pararectal space will be entered by blunt dissection till
the sacrospinous ligament is reached. The rectum will be mobilized medially. Once the ischial
spine is identified, SSL is palpated by dorsal and medial movement of the fingers. Any
fibroareolar tissue present over the ligament will be removed with the swab held in sponge
holding forceps. Per rectal examination is performed to rule out rectal injury. For proper
visualization of SSL, Breisky-Navratil retractor will be used. A permanent suture Polyster no
1 will be passed through the SSL around 1.5 to 2 cm medial to the ischial spine under direct
vision with the help of long needle holder. The other end of the suture is brought out to the
right end of vaginal vault and it will be tagged. Another suture will be placed in SSL medial
to the previous one and again brought out to the vault towards left end and will be tagged.
Anterior repair if needed will be performed. The upper portion of posterior vaginal wall
mucosa will be closed. The suspension sutures are then tied so that the vagina comes in
contact with the SSL without the bridge of suture in between. Posterior colpoperinorrhaphy
will then be performed. If anti-incontinence procedures are needed, will also be performed.
Method of Uterosacral Ligament Suspension (USLS) For all the women with uterine descent
requiring the hysterectomy, vaginal hysterectomy will be performed using standard method. The
pedicles of the uterosacral ligaments will be tagged. For women with vault prolapse, a
horizontal incision will be given at the level of vault. It will be opened and the enterocele
sac will be dissected off the vaginal mucosa. The enterocele sac will opened for the
intraperitoneal access of uterosacral ligament. The posterior-cul-de-sac will be packed with
moist gauze. The remnants of the uterosacral ligaments will be identified medial to the
ischial spine. A non-absorbable suture; Polyster no 1 will be passed through the uterosacral
ligament at the level of ischial spine. Another suture with the same suture material will be
passed through the ligament around 1 cm below the ischial spine. The one end of the suture is
passed through the anterior vaginal wall and the other end through the posterior vaginal
wall. Same procedure will be repeated on the other side. Anterior colporrhaphy if needed will
be performed. The suspension sutures will then be tied. Posterior colpoperineorrhaphy,
anti-incontinence procedure if needed will be performed thereafter.
In case the allocated procedure cannot be performed for vault suspension, alternative surgery
will be performed. If both the procedures cannot be performed, the procedure for apical
suspension will be decided by the operating surgeon. During the surgery, duration of the
surgery, intraoperative blood loss, occurrence of urinary or bowel injury will be noted.
Cystoscopy will be performed after each surgery to rule out urinary tract injury.
2.4. Follow up After the surgery the patients will be managed in postoperative wards as per
the hospital protocol. The duration of catheterization, post-operative hospital stay will be
recorded. All women will be taught and advised to perform pelvic floor muscle training (PFMT)
at the time of discharge. The postmenopausal women will be prescribed with local estrogen
cream. Following the discharge women will be scheduled for follow up in 6 months and one year
of surgery. However, if patient experiences any complications, she is advised to follow up
immediately. The complication developed will be managed as needed and the event will be
recorded. During each follow up, women will be enquired about the symptoms according to
PFDI-20, POP-Q examination will be performed.
3. Measurement 3.1. Primary outcome Success rate of SSLF and USLS for apical suspension
Success will be defined as absence of any of the following
1. Stage II or greater apical compartment prolapse
2. Awareness of bulge symptoms confirmed by affirmative response to question number 3 of
PFDI-20.
3. Need of additional treatment for prolapse (ring pessary, repeat surgery)
4.2. Secondary outcome Perioperative outcomes Duration of surgery Intraoperative blood loss
Duration of catheterization Duration of Hospital stay
1. Complications Bladder, ureteric or bowel injury, neurological injury, vascular injury
Urinary retention, Vault hematoma, Dyspareunia
2. Change in PFDI-20 score The intraoperative blood loss will be calculated by the change
in perioperative hematocrit concentration ( difference between pre-operative hematocrit
and hematocrit sent on first postoperative day) using the formula(25); Vloss total = BV
X (Hctpreop - Hctpostop) The blood volume will be calculated using the formula(26), BV=
k1 x H3 + k2 x W + k3 For females, k1 = 0.3561, k2= 03308 and k3 = 0.1833
5. Adverse events
Adverse event (AE) will be recorded as per Clavein Dindo classification of surgical
complications which is as follows:
Grades Definition Grade I Any deviation from the normal postoperative course without the need
for pharmacological treatment or surgical, endoscopic and radiological interventions.
Acceptable therapeutic regimens: drugs like antiemetics, antipyretics, analgesics, diuretics
and electrolytes and physiotherapy.
Also includes wound infections opened at the bedside. Grade II Requiring pharmacological
treatment with drugs other than such allowed for grade I complications.
Blood transfusions and total parenteral nutrition are also included. Grade III Requiring
surgical, endoscopic or radiological intervention Grade III-a: intervention not under general
anesthesia Grade III-b: intervention under general anesthesia Grade IV Life-threatening
complication (including CNS complications) requiring IC/ICU-management Grade IV-a: Single
organ dysfunction (including dialysis) Grade IV-b: Multi organ dysfunction Grade V Death of a
patient Suffix 'd': If the patient suffers from a complication at the time of discharge, the
suffix "d" (for 'disability') is added to the respective grade of complication. This label
indicates the need for a follow-up to fully evaluate the complication
Any complications equal to or greater than grade III, will be labeled as Severe adverse
events (SAEs). All SAEs will be managed as per the hospital protocol. Any such events will be
reviewed thoroughly and the factor responsible for SAE will be identified so as to prevent
them in future.
6. Statistical consideration Both descriptive and inferential statistics will be used. The
outcome variables will be expressed as frequency and percentage for categorical variables,
mean with standard deviation; median and interquartile range for continuous variables. The
association between the categorical outcome variables will be sought using Chi square test.
The comparison of difference in mean score between the same group will be performed by paired
T test while the comparison of means between two different groups will be done by independent
T test.
7. Data Management
The data will be collected by the principal investigator. The validity and fidelity of the
data will be periodically monitored by the DSMB. The data will be collected using preformed
proforma and PFDI-20. The collected data will be coded and entered in Ms Excel spreadsheet.
The data will be then analyzed using SPSS version. The primary outcome will be analyzed
according to original treatment assignment plan (Per protocol analysis). The success will
also be analyzed according to intention to treat analysis.
