Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Investigators will exclude women with
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) | Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) |
| |
| Vaginal Hysterectomy and Vaginal vault suspension (VAH+VVS) | Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POP-Q | Other | Pelvic Organ Prolapse Quantification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Pelvic Organ Prolapse | Number of Participants with Recurrence of Pelvic Organ Prolapse | Postoperative first year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women attending the gynecology clinic at a tertiary referral urogynecology unit in our hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cihan Kaya | Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakirkoy Dr. Sadi Konuk Training and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) | Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) |
| FG001 | Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS) | Patients who were performed a vaginal hysterectomy and Vaginal vault suspension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) | Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification |
| BG001 | Vaginal Hysterectomy and Vaginal Vault Suspensio (VAH+VVS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Recurrence of Pelvic Organ Prolapse | Number of Participants with Recurrence of Pelvic Organ Prolapse | Posted | Count of Participants | Participants | Postoperative first year |
|
12 months
there was no adverse event observed in both groups
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Assisted Laparoscopic Sacrohysteropexy(VALS) | Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ismail Alay | bakirkoy dr sadi konuk training and research hospital | +905462375638 | dr_ismailalay@hotmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2020 | Aug 17, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| change from preoperative measurement of pop-q point c at postoperative first year |
| ICIQ-VS Vaginal Symptom Subscale | International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ıcıq-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 |
Patients who were performed a vaginal hysterectomy and Vaginal Vault Suspension (VAH + VVS) POP-Q: Pelvic Organ Prolapse Quantification |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ-VS) | International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ıcıq-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. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | centimeters | 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 (ıcıq-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. | Posted | Mean | Standard Deviation | score on a scale | change from preoperative ICIQ-VS vaginal symptom subscale score at postoperative first year |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS) | Patients who were performed vaginal hysterectomy and Vaginal vault suspension POP-Q: Pelvic Organ Prolapse Quantification | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
Not provided