Lateral Colporrhaphy - a New Surgical Intervention: Case Series Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Primary Endpoint
- Occurrences of site-specific defects within the lateral vaginal wall
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Occurrences of site-specific defects within the lateral vaginal wall
Time Frame: Duration of the surgical phase of the study
To determine the existing of defects during actual surgery
Secondary Outcomes
- Measuring objective and subjective cure rates of lateral colporrhaphy.(Duration of the surgical phase of the study)