Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04635514 |
Other study ID # |
IGynecology |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 15, 2012 |
Est. completion date |
November 7, 2019 |
Study information
Verified date |
November 2020 |
Source |
Institute of Gynecology, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
LATERAL COLPORRHAPHY: A NEW SURGICAL INTERVENTION:
CASE SERIES STUDY
Background The surgical anatomy of site-specific defects of lateral vaginal wall (LVW)
prolapse into the canal and its treatment are described for the first time.
Materials and Methods Thirty-two women who presented with symptomatic LVW prolapse (deep
dyspareunia, sensation of vaginal fulness, and heaviness) were study. Before surgery, gross
anatomy and the lateral colporrhaphy rehearsals had been performed on ten-human fresh female
cadavers. A case series study was designed and conducted. Objectives were to ascertain the
surgical anatomy within lateral vaginal wall site-specific defects; to evaluate whether
lateral colporrhaphy can cure or improve symptoms; to describe a new lateral colporrhaphy.
The primary outcome measured occurrences of site-specific defects within the lateral vaginal
wall. The secondary outcome measured objective and subjective cure rates of lateral
colporrhaphy.
Results Twenty-eight women (87.5%) concluded the study. The mean age of women was 46 ± 12
years, BMI 26.7 ± 2 kg/m2, and vaginal parity 2 ± 1. In all subjects, LVW defects had bulged
into the vaginal canal. Lateral colporrhaphy yielded objective and subjective cure rates of
93% and 97%, respectively. Symptomatic improvements were recorded in 7%. The LVW surgical
anatomy consisted of the full thickness of the vaginal wall, pubovaginalis muscle with
fascia, and the perineal membrane.
Conclusions Symptomatic site-specific defects occur within the lateral vaginal wall. Lateral
colporrhaphy cures or improves symptoms in this study group. The new lateral colporrhaphy
procedure is a simple surgical intervention and is easy to perform.
Description:
Material & methods
2.1 Ethics The author follows the ethical standards in this clinical-scientific study and
complains with the Declaration of Helsinki [7, 8]. The local Institutional Review Board (IRB)
was consulted with the study protocol and informed consent. Based on the Declaration of
Helsinki, Section C, entitled "Unproven Interventions in Clinical Practice," the study was
excluded from an IRB formal process. IRB advised referencing the Helsinki Declaration [7, 8].
All subjects had been furnished with informed consent in writing before enrollment. The
cadaver study was approved by the local university Ethics Committee (no. AKBE 146/12).
2.2 Preoperative Evaluation The Numeric Pain Rating Scale (NPRS) was used to determine the
severity of dyspareunia, and the subject's report was incorporated in evaluating other
symptoms. All study participants were furnished with the standardized self-reported (NPRS)
form. The numeric formula ranging from 0 to 10 (0, no pain; 1- 4, mild pain; 5 -7, moderate
pain; 8-10, severe pain). Patients' dyspareunia severity was recorded based on the woman's
real pain experience during vaginal intercourse.
The lateral vaginal walls were assessed from fornix to the exterior vaginal introitus,
site-specific defects were identified and recorded, and photos were taken. Deep dyspareunia
was reproduced during a clinical vaginal evaluation by poking a defective lateral vaginal
wall. Induced surrogate pain was the endpoint for actual in-depth deep dyspareunia
evaluation. In each follow-up visit, the author determined the objective cure rate with
patient assistance. For this purpose, Extra-Absorbent Large Tipped Applicators with Plastic
Handle (Puritan Medical Products, Guilford, ME 04443-0149, USA) were used. Patients reported
the severity of pain, and the author charted pain. The protruding part of the LVW into the
vaginal canal was evaluated by direct visualization. The prolapsing part was measured from
the base of LVW to the most protruded portion of the lateral vaginal. This evaluation was
applied preoperatively and during each follow-up visit.
2.3 Data Collection and Analysis Objective data were collected during a one-on-one interview
performed by the author with every subject. Subjective data collected before and after
surgery and yearly intervals until the completion of the follow-ups. Findings were compared
with preoperative results, follow-up visits, and recorded.
2.4 Literature Search Zotero - reference manager, and PubMed, and other non-indexed studies
were used for electronic medical literature searches regarding the lateral vaginal wall
anatomy, site-specific defects within this structure, and surgical reconstruction. The
Medical Subject Headings (MeSH) applied to gather relevant articles. Conference Proceedings
and specializing website included in searches. Keywords were used: Vaginal wall anatomy;
Vaginal wall surgical anatomy; Vaginal wall defects; Vaginal introitus; Vaginal tightening;
Vaginal introitus; Vaginal walls; Lateral vaginal wall defects; Lateral vaginal wall defect
repairs; Vaginal colporrhaphy.
2.5 Informed Consent Every subject in the before enrollment received written informed
consent, which is presented in the present study. At the time of pre-surgical consultation,
all patients were educated, in understandable terms, on the lateral colporrhaphy. The formal
inform consent is included in the supplemental file.
2.6 Local Anesthesia All lateral colporrhaphy performed under local anesthesia. One-hour
before the operation, a mixture of Lidocaine/Prilocaine (2.5%/2.5%) cream would be applied by
the patient to the vaginal canal, the posterior perineum, the vaginal vestibule. Thirty
minutes before the surgery, orally, Valium 2.5-5 mg and Phenergan 12.5 mg rectal suppository
for light conscious sedation was administered. Bupivacaine 0.5 % with epinephrine solution
(Hospira, Inc., Lake Forest, IL USA) used for vaginal wall infiltration if a patient was not
sensitive to this agent (a skin test would be done before a surgical intervention).
2.7 Inclusion and Exclusion Criteria The consecutive corpses who demised within 24-hour and
did not undergo a preservation process were included for the study and rehearsal. Those alive
women who presented with lateral vaginal defects prolapsing into the vaginal canal and
affiliated with moderate to severe deep dyspareunia were included. Anteverted uterus,
anterior or posterior, colporrhaphy, and intact paravaginal suspension were prerequisites for
inclusion. No concomitant procedure was performed during lateral vaginal wall repair. Women
who presented with anterior or posterior vaginal wall defects (cystocele or rectocele),
paravaginal defect, lateral vaginal defect, and did not have a prior surgical treatment for
those conditions were excluded. Retroverted uterus, pregnancy, current infection of the lower
genital tract, general illnesses, and inflammatory disorder constituted reasons for subjects
being excluded from the study. Additionally, women who underwent a prior hysterectomy,
bilateral oophorectomy, or had the diagnosis of vaginal dryness, endometriosis, prolapse,
myofascial pain were excluded. A total of eight patients were excluded from the study.
2.8 Cadaveric Rehearsal Stratum-by-stratum anatomical cadaveric dissection was performed to
verify the gross anatomy on one side of the same subject to identify the lateral vaginal wall
and its supportive/suspending structures. On the other side of the same corps, rehearsal of
the newly developed lateral vaginal wall colporrhaphy concept was exercised according to the
narrative description of this surgical intervention, which is described below.
2.9 Surgical Intervention The surgery on live subjects was performed under x 3,5-4.0
magnifying loupe. A small vertical incision was made approximately 0.5 - 1.0 cm from the
inner hymeneal ring on the lateral vaginal mucosa (between 2 and 3 o'clock on the left and 8
and 9 o'clock on the right side). The incision continued until after the full thickness of
the vaginal wall was exposed. A traction suture, without tying, placed on the distal edge of
the incision. The full thickness of the vaginal wall was dissected-off from vaginal
inner-lateral defect. Approximately 1.0 cm above the proximal defect, another traction suture
placed, without tying, and lateral sub-vaginal anatomical defect(s) was exposed. Both
traction sutures were stretched, and scarification of defect edges was carried out until
fresh oozing blood was observed. Edges of defects were approximated with a simple interrupted
2-0 delayed absorbable suture on a tapered, small needle. Site-specific defects
reconstructions were completed in layers; the vaginal mucosa was trimmed and closed with a
single interrupted 3-0 delayed stitch on a taper needle. Meticulous hemostasis was achieved.
The overall procedure duration was measured in each case from the first incision to the
operation's completion. The follow-up study was conducted at a one-year interval for 3 years.