Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse: a Prospective Randomized Study
Conditions: Pelvic Organ Prolapse
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Document Date: 10.01.2020 
NCT: NCT03436147 
Vaginal-assisted 
laparoscopic 
sacrohysteropexy 
(VALH) 
and 
vaginal 
hysterectomy+vaginal vault suspension (VH+VVS) for advanced uterine prolapse: 12-
month preliminary results of a randomized controlled study 
Materials and Methods 
In this study, the first-year results of a single-center, randomized controlled study of two 
parallel groups, conducted in the tertiary referral training and research hospital, were evaluated. 
The study included women who were admitted to our urogynecology unit for stage 2–4 
symptomatic uterine prolapse between June 2017 and January 2019. The study was approved 
by our hospital’s local ethics committee (approval number: 2018/23). 
Requirements for participation were that the women be over 18 years of age with no 
desire to preserve fertility (subjects had completed childbearing or were practicing reliable 
contraception), have a normal size uterus (< 10 cm) on examination or ultrasound, and agree to 
participate in principle. They were then given further information about the trial, and consent 
was sought either in an outpatient clinic or at the next visit for preoperative assessment. 
Exclusion criteria were: cervical elongation (surgeon’s discretion), prior prolapse surgery, 
current foreign-body complications, increased risk or recent history of cervical dysplasia, 
chronic pelvic pain, significant uterine abnormalities, abnormal menstruation or 
postmenopausal bleeding within the previous 12 months, and a significantly enlarged fibroid 
uterus or concomitant medical problems precluding general anesthesia or the assumption of a 
steep Trendelenburg position. Written informed consent was obtained from all of the 
participants. 
Participants were randomly assigned to either of two groups: Group A (VALH) or 
Group B (VH+VVS ). The consolidated standard of reporting trials (CONSORT) flow study 
diagram is presented in Figure 1. Simple randomization was performed by the distribution of 
blind envelopes in order to separate the patients into the groups; this randomization was 

performed before admission to surgery. Those who subsequently had a strong preference for 
either operation and consequently declined to continue in the study were excluded and not put 
through the randomization process.  
Age, parity, body mass index (BMI), intraoperative blood loss, operation time, and 
postoperative hospital stay were recorded. Blood loss was assessed by volume of blood and the 
weight of soaked pads. BMI was calculated as the weight (kg) divided by the square of the 
height (m2). 
Surgeries were performed under general anesthesia with the help of residents and one 
specialized urogynecologist. The VALH operation was initiated with conventional 
laparoscopy. Then, one 10 mm umbilical and two 5 mm lower abdominal trocars were inserted 
after obtaining sufficient pneumoperitoneum with a Veress needle (Ethicon Endo-surgery Inc., 
USA). Conventional laparoscopic 5 mm grasping forceps and scissors were used to perform the 
laparoscopic phase of the surgery. The peritoneum over the sacral promontory was incised 
(Figure 2a). At the vaginal phase of the surgery, a semi-circular incision was made at the 
posterior cervicovaginal junction. Curved ring forceps were introduced through with blunt 
dissection over the right sacrouterine ligament to establish a tunnel towards to the incised 
opening over the sacral promontory. This step was visualized simultaneously via laparoscopy 
(Figure 2b). A 15x3 cm, tailored, macroporous, non-absorbable polypropylene monofilament 
mesh (15cm-15 cm; Ethicon, Somerville, NJ, USA) was taken into the abdomen through the 10 
mm trocar. When the ring forceps reached the incision at promontory level, the tip of the mesh 
was grasped and pulled down through the retroperitoneal tunnel until it came to the posterior 
cervix. The mesh was fixed to the posterior face of the uterine cervix using non-absorbable 
sutures through the vaginal route (Figure 2c). The semicircular vaginal incision was closed with 
absorbable sutures (Vicyrl 1; Ethicon, Somerville, NJ, USA) after attaching the mesh to the 
cervix. Finally, after uterine suspension was maintained with pushing the uterus to its normal 

position, the abdominal part of the mesh was sutured to the anterior longitudinal ligament at the 
sacral promontory with non-absorbable sutures using a laparoscopic technique (Figure 2d). The 
excess part of the mesh was cut with scissors and removed from the abdomen through a trocar. 
The peritoneal incision at the promontory level was closed with absorbable sutures to cover the 
fixated mesh (Figure 2e). 
The VH+VVS operation was initiated with a circumferential incision in the vaginal 
epithelium at the junction of the cervix. After the dissection of the vaginal epithelium, we 
entered the abdominal cavity along the anterior and posterior planes of the uterus. Uterosacral 
and cardinal ligaments, uterine vessels, broad ligaments, and utero-ovarian pedicles were 
classically identified, clamped, cut, and ligated with absorbable sutures (Vicryl 1; Ethicon, 
Somerville, NJ, USA). The uterosacral ligaments were attached with absorbable sutures to the 
vaginal vault after hysterectomy for vaginal vault support. Sacrospinous ligament fixation 
surgeries were also performed for patients whose vaginal vaults were less than 2 cm from the 
hymen after vaginal hysterectomy. Finally, the vaginal cuff was closed by a running locking 
stitch with absorbable sutures.  
Additional concomitant surgeries, including anterior and posterior colporrhaphy and 
perineoplasty, were performed after apical suspension, as needed. Additional anti-incontinence 
surgeries were performed in accordance with the patient–surgeon interviews after preoperative 
evaluation, including urodynamic examination. In daily practice, we perform a urodynamic 
examination before surgery for patients who have advanced uterine prolapse with or without 
complaints of stress urinary incontinence. However, in this case, the participants who had a 
confirmed diagnosis of stress urinary incontinence or were diagnosed with occult stress 
incontinence in the urodynamic study had anti-incontinence surgery suggested to them. 
Tension-free vaginal tape surgery was performed by a separate anterior mid-urethral incision if 
needed. 

On the day of the operation, the allocation was confirmed, and appropriate consent was 
obtained for the given surgical procedures. Vaginal hysterectomy and laparoscopic hysteropexy 
were combined with anterior and/or posterior repair at the surgeon’s discretion at the time of 
the operation. Each participant was initially followed-up with in the clinic at one week, one 
month, three months, and one year post-surgery as part of departmental procedure. 
Postoperative pain scores were evaluated 24 hours after surgery by a visual analog scale (VAS) 
score. Uterovaginal prolapse was assessed again using the International Consultation on 
Incontinence Questionnaire Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ 
Prolapse Quantification (POP-Q) system by another researcher, and then the operator. During 
interviews, further questions were asked regarding postoperative recovery, current urinary 
symptoms, and satisfaction with the operation. Subjective surgical outcome was measured 
using the Patient Global Impression of Improvement (PGI-I), which is a validated global index 
of response to prolapse surgery consisting of a seven-point scale upon which patients may 
compare their preoperative and postoperative conditions (with 1 being “very much better” and 
7 being “very much worse”).[9] The PGI-I scale was evaluated one year after surgery with each 
of the patients. 
The participants’ prolapse symptoms, and their impacts, were evaluated both before and 
one year after surgical treatment. A subjective assessment of the prolapse was made using the 
ICIQ-VS.[10] Objective assessment of pelvic organ prolapse was performed during a Valsalva 
maneuver using a Sims’ speculum, and the frequently-used POP-Q scale was evaluated.[11] 
Patients were also asked to complete the Urogenital Distress Inventory Short Form (UDI-6) and 
the Incontinence Impact Questionnaire Short Form (IIQ-7). The UDI-6 and IIQ-7 are accepted 
as validated questionnaires that are useful in the assessment of urogenital symptoms and 
disease-specific quality of life.[12] 

The measure for the primary outcome was treatment failure, defined as recurrent apical 
prolapse that required surgery within the first year after initial surgery. The secondary outcome 
measures were changed in anatomy quantified by POP-Q and symptoms quantified using the 
ICIQ-VS questionnaire scores for prolapse, quality of life, and PGI-I, UDI-6, IIQ-7 scores. 
Other secondary outcome measures were operation time, pain score, blood loss, and 
postoperative hospital stay. 
Statistical analysis 
Data analysis was performed with SPSS (version 20.0; Chicago, IL). Data were 
analyzed using descriptive statistical methods (mean, standard deviation, median, frequency, 
rate, minimum, and maximum). One sample Kolmogorov–Smirnov test was performed to 
analyze the distribution of the data. For group comparisons of parameters with quantitative data 
showing normal distribution, Student’s t-test was used, while a Mann–Whitney U test was used 
for comparing other parameters not showing normal distribution. A p value of less than .05 was 
considered statistically significant.