Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy

Pelvic Organ Prolapse Clinical Trial

Official title:

Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436147
• Other study ID #: VALHvsVAH
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2020
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported. To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy. Women attending the gynecology clinic at a tertiary referral urogynecology unit in tertiary referral training and research hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period. Subjects participating in the study were randomly assigned to either of two groups: Group A, Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call Culdoplasty (VH + Mc Call).1 year following surgery, vaginal prolapse will be assessed again using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by another researcher then the operator.

Description:

Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on patient-centered medicine and patient-generated definitions of surgical success has resulted in reassessment of uterine preservation versus hysterectomy at the time of apical pelvic organ prolapse (POP) repair. Comparison of study outcomes between hysteropexy and hysterectomy are confounded by anatomic variables (isolated apical prolapse or multiple compartment prolapse), hormonal status (premenopausal, postmenopausal on hormone therapy, and postmenopausal without hormone therapy), and surgical approach (vaginal, open abdominal, laparoscopic, and robotic). In addition, the number of women who subsequently undergo hysterectomy after a uterus-sparing prolapse surgery is not known. With the caveat of these limitations, new short-term data are available to inform consideration of uterine-sparing POP repair. Various techniques have been described for uterine preserving prolapse surgery, which may include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was introduced and a series of 70 women was reported.To date, there have been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine suspension (hysteropexy) with conventional vaginal hysterectomy.

This is a single-center, randomized controlled study of two parallel groups. Women attending the gynecology clinic at a tertiary referral urogynecology unit requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse will be offered participation in a randomized trial, over a 2-year period between February 2018 and February 2020.

Requirements for women recruited are that

• patients who are over 35 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

• who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.

Investigators will exclude women with

• cervical elongation (surgeon discretion),

• prior mesh prolapse repair,

• current foreign-body complications,

• increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.

• Postmenopausal bleeding in the past 12 months

• Women with a significantly enlarged fibroid uterus or concomitant medical problems precluding general anesthesia or the use of a steep Trendelenburg position Subjects participating in the study will be randomly assigned to either of two groups: Group A, Vaginally Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Vaginal Vault Suspension (VAH + VVS). Those recruited who subsequently have a strong preference or either operation and consequently decline to continue in the study will be excluded and will not randomized.

VALH surgical procedure described below:

The procedure was performed under general anesthesia with the patient initially in the lithotomy position. After insertion of a urinary catheter, a 2 cm transverse vaginal incision was performed to the posterior cervix. The vaginal mucosa on the posterior cervix was dissected and type 1 polypropylene mesh secured to the posterior cervix with six 2/0 polydioxanone sutures. After skin preparation, and draping, a pneumoperitoneum was created and three laparoscopic ports were placed; 11 mm umbilical, 5 mm left and right lateral ports, and 5 mm suprapubic port. The sacral promontory was subsequently visualized and the presacral peritoneum was opened with monopolar diathermy and laparoscopic scissors.The tail end of the mesh was then push forward to the promontorium in the retroperitoneal region under laparoscopic visualisation. The end of the mesh grasped and pulled up laparoscopically. The uterus pushed up to the using the uterine manipulator. The mesh was then tacked to the sacral promontory with 5 mm helical fasteners. Finally, the mesh was completely covered with peritoneum, gas was expelled and ports were withdrawn under vision. Skin incisions were closed with absorbable fine sutures.

On the day of the operation allocation will be confirmed and appropriate consent will be obtained for the specific surgical procedure. Vaginal hysterectomy + Mc Call Culdoplasty and vaginal assisted laparoscopic hysteropexy will combined with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Each woman will be followed up initially in the clinic 3 months post-surgery as part of the departmental routine. Participants will then invite for review, as part of the trial, at a dedicated clinic, 1 year following surgery. Vaginal prolapse will be assessed again using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse Quantification (POP-Q) examination by another researcher then the operator. During the interview, further questions will be asked regarding post-operative recovery, current urinary symptoms, Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7) and their satisfaction with the operation. Subjective surgical outcome will be measured using the Patient Global Impression of Improvement (PGI-I), which is a validated tool as a global index of response to prolapse surgery.

The women's prolapse symptoms and their impact will be evaluated before surgical treatment.

1. A subjective assessment of the prolapse will be made using the ICIQ-VS

2. Objective assessment of pelvic organ prolapse will be performed during a Valsalva maneuver, in the left lateral position, using a Sims' speculum. Investigators use the pelvic organ prolapse quantification (POP-Q) system.

3. Patients will be also asked to complete the Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7). UDI-6 and IIQ-7 are accepted as validated questionnaires that are useful in the assessment of urogenital symptoms and disease-specific QoL.

The measure for primary outcome is treatment failure defined as recurrent apical prolapse surgery required within the first year post-operatively.

The secondary outcome measures are change in anatomy quantified by POP-Q and symptoms quantified using the ICIQ-VS questionnaire scores for prolapse, sexual wellbeing, quality of life, and PGI-I score, UDI-6 and IIQ-7 scores. Other secondary outcome measures are operation time, blood loss, hospital stay, and time before return to normal activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients who are over 35 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

• who agree to participate in principle will be given further information about the trial and consent will be obtained either in an outpatient clinic or at the next visit for preoperative assessment.

Exclusion Criteria:

• cervical elongation (surgeon discretion),

• prior mesh prolapse repair,

• current foreign-body complications,

• increased risk or recent history of cervical dysplasia, chronic pelvic pain, significant uterine abnormalities, and abnormal menstruation.

• postmenopausal bleeding in the past 12 months

• women with a significantly enlarged fibroid uterus

• concomitant medical problems precluding general anesthesia or the use of a steep trendelenberg position

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• POP-Q
Pelvic Organ Prolapse Quantification

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Recurrence of Pelvic Organ Prolapse	Number of Participants with Recurrence of Pelvic Organ Prolapse	Postoperative first year
Secondary	POP-Q SYSTEM Point C MEASUREMENT	The POP-Q system is an objective, site-specific system for describing and staging POP in women. The measurement is then taken of the distance from the point to the hymenal plane. Point C is defined as the most distal (ie, most dependent) edge of the cervix or the leading edge of the vaginal cuff (posthysterectomy). Preoperative and postoperative one year measurement of point C according to POP-Q system will be recorded and the change from preoperative measurement at postoperative first year is secondary outcome of this study.	change from preoperative measurement of pop-q point c at postoperative first year
Secondary	ICIQ-VS Vaginal Symptom Subscale	International Consultation on Incontinence Questionnaire-Vaginal Symptoms (iciq-vs ) score of the patient after postoperative one year. This score includes 14 questions as Dragging abdominal pain, Vaginal soreness, Reduced sensation around vagina, Vagina too loose/lax, Lump coming down in vagina, Lump coming out of vagina, Dry vagina, Digitation for bowel opening, Tight vagina, Current sex life, Worries about vagina affect sex life, Relationship Sex life spoilt, Overall impact on everyday life. ICIQ-VS score ranges between 0 and 53. Higher ICIQ-VS scores represent worse outcome.	change from preoperative ICIQ-VS vaginal symptom subscale score at postoperative first year