Prolapse UterovaginalNCT05558852
Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
A study testing Laparoscopic Meshless Sacrocolpopexy Technique in people with Prolapse Uterovaginal and Prolapse Bladder, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse Uterovaginal, Prolapse Bladder, Laparoscopy
- What is being tested?
- Laparoscopic Meshless Sacrocolpopexy Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients older than 30 years and younger than 80 years old
- Patients who provided written consent for this surgical procedure
Who cannot join
- Patients who cannot obtain anesthesia approval for laparoscopic surgery
- Patients with asymptomatic pelvic organ prolapse
- Patients with active pelvic inflammatory disease
- Patients who have a confirmed or suspected pregnancy or malignancy
- Patients who have an unexplored abnormal cervical-uterine cytology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Childrens Training and Research Hospital
Istanbul, 34660
Resul Karakus, MD, +905059164216, resul-karakus@hotmail.com
About this study
Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. In some studies, the rate of mesh complications (such as mesh erosion, contraction, response, and pain) can reach 20%. This surgical approach aims to provide laparoscopic repair of pelvic organ prolapse without the use of mesh, hence avoiding the difficulties associated with mesh.
Read the detailed description
Patients who present to the Zeynep Kamil Education and Research Hospital Gynecology and Obstetrics Clinic between July 2022 and April 2023 with the complaint of prolapse and have uterine or vaginal cuff prolapse due to a central defect or cystocele due to an anterior compartment defect and are indicated for surgery will be included in the study.The surgeries will be performed laparoscopically after obtaining their written consent.
The Technique;
- The anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament.
- Dissection from this region, extension of the right sacrouter ligament from the lateral to the vaginal cuff or retrocervical region as well as visualization of the right ureter, isolation of the right sacrouterine ligament.
- Dissection of the vesicovaginal space by cutting the vesicouterine peritoneum and eradication of the bladder. Lower limit of anterior compartment dissection; Exposing the puboservicovaginal fascia sufficiently to repair the anterior defect and exposing the defect.
- Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection.
- Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus).
- Repairing the defective pubocervico-vaginal fascia using 2.0 prolene for an anterior compartment defect and suturing this fascia to the cervical ring or sacrouterine ligaments in the vaginal cuff using 2.0 prolene.
- Attaining the sacral promontory with two strong sutures starting from the vaginal cuff or cervix using 1.0 prolene and continuous circular sutures along the right sacrouterine ligament while using the same suture.
- After passing 1 strong suture through the anterior longitudinal ligament, the same suture will be continued along the right sacrouterine ligament in a continuous and circular manner.
- Knotting where the suture begins to create sufficient tension (maintaining the vaginal cuff level at -2) (The sacrocolpopexy technique: transforming the sacrouterine ligament into a rope with an insoluble suture material).
- Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.
- Conditions
- Prolapse Uterovaginal, Prolapse Bladder, Laparoscopy
- Being tested
- Laparoscopic Meshless Sacrocolpopexy Technique
- Keywords
- Laparoscopy, Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Meshless Sacrocolpopexy TechniqueProcedure or surgery
Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse
| Study group | Role | What they receive |
|---|---|---|
| Meshless Approach | Experimental | Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse. Receives: Procedure: Laparoscopic Meshless Sacrocolpopexy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog Scale
Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.
Measured: 6 months after the operation
POP-Q classification
examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.
Measured: 6 months after the operation
PQOL
Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.
Measured: 6 months after the operation
FSFI
Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.
Measured: 6 months after the operation
Urinary Incontinance
Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)
Measured: 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start15 Jul 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse UterovaginalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Anticipated 25 patients will be evaluated and operated with meshless method.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558852
- Sponsor's protocol ID
- 84/2022
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
- ClinicalTrials.gov ID
- NCT05558852
- Acronym / sponsor ID
- 84/2022
- Conditions
- Prolapse Uterovaginal, Prolapse Bladder, Laparoscopy
- Keywords
- Laparoscopy, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. In some studies, the rate of mesh complications (such as mesh erosion, contraction, response, and pain) can reach 20%. This surgical approach aims to provide laparoscopic repair of pelvic organ prolapse without the use of mesh, hence avoiding the difficulties associated with mesh.
Detailed description
Patients who present to the Zeynep Kamil Education and Research Hospital Gynecology and Obstetrics Clinic between July 2022 and April 2023 with the complaint of prolapse and have uterine or vaginal cuff prolapse due to a central defect or cystocele due to an anterior compartment defect and are indicated for surgery will be included in the study.The surgeries will be performed laparoscopically after obtaining their written consent.
The Technique;
- The anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament.
- Dissection from this region, extension of the right sacrouter ligament from the lateral to the vaginal cuff or retrocervical region as well as visualization of the right ureter, isolation of the right sacrouterine ligament.
- Dissection of the vesicovaginal space by cutting the vesicouterine peritoneum and eradication of the bladder. Lower limit of anterior compartment dissection; Exposing the puboservicovaginal fascia sufficiently to repair the anterior defect and exposing the defect.
- Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection.
- Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus).
- Repairing the defective pubocervico-vaginal fascia using 2.0 prolene for an anterior compartment defect and suturing this fascia to the cervical ring or sacrouterine ligaments in the vaginal cuff using 2.0 prolene.
- Attaining the sacral promontory with two strong sutures starting from the vaginal cuff or cervix using 1.0 prolene and continuous circular sutures along the right sacrouterine ligament while using the same suture.
- After passing 1 strong suture through the anterior longitudinal ligament, the same suture will be continued along the right sacrouterine ligament in a continuous and circular manner.
- Knotting where the suture begins to create sufficient tension (maintaining the vaginal cuff level at -2) (The sacrocolpopexy technique: transforming the sacrouterine ligament into a rope with an insoluble suture material).
- Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anticipated 25 patients will be evaluated and operated with meshless method.
| Arm | Type | Receives |
|---|---|---|
| Meshless Approach | Experimental | Procedure: Laparoscopic Meshless Sacrocolpopexy TechniqueLaparoscopic Sacrocolpopexy in central or anterior compartment prolapse. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients older than 30 years and younger than 80 years old
- Patients who provided written consent for this surgical procedure
Key exclusion criteria (5 listed)
- Patients who cannot obtain anesthesia approval for laparoscopic surgery
- Patients with asymptomatic pelvic organ prolapse
- Patients with active pelvic inflammatory disease
- Patients who have a confirmed or suspected pregnancy or malignancy
- Patients who have an unexplored abnormal cervical-uterine cytology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Meshless Sacrocolpopexy TechniqueMeshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse | Procedure or surgery | Meshless Approach |
Primary outcome
Visual analog Scale
Time frame: 6 months after the operation
Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.
POP-Q classification
Time frame: 6 months after the operation
examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.
PQOL
Time frame: 6 months after the operation
Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.
FSFI
Time frame: 6 months after the operation
Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.
Urinary Incontinance
Time frame: 6 months after the operation
Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Meshless Sacrocolpopexy Technique in people with Prolapse Uterovaginal and Prolapse Bladder, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Resul Karakus, MD (05059164216, resul-karakus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog Scale (time frame: 6 months after the operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.