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Status unknownNCT05558852Updated Sep 30, 2022

Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique

An interventional study of Laparoscopic Meshless Sacrocolpopexy Technique in Prolapse Uterovaginal, Prolapse Bladder and Laparoscopy, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
30 Years to 80 Years
Sex
Female
01

Study 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. 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;

  1. The anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament.
  2. 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.
  3. 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.
  4. Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection.
  5. Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus).
  6. 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.
  7. 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.
  8. 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.
  9. 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).
  10. Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.
02

Conditions studied

  • Prolapse Uterovaginal
  • Prolapse Bladder
  • Laparoscopy

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Keywords

  • Laparoscopy
  • Pelvic Organ Prolapse
03

In context

Pelvic Organ Prolapse

521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's planned enrollment of 25 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients older than 30 years and younger than 80 years old
  • Patients who provided written consent for this surgical procedure

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients who have an unexplored abnormal cervical-uterine cytology
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Meshless Approach

    Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.

    Procedure: Laparoscopic Meshless Sacrocolpopexy Technique

Interventions

  • ProcedureLaparoscopic Meshless Sacrocolpopexy Technique

    Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse

06

What researchers measure

Primary outcomes

  1. Visual analog Scale

    Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.

    Time frame: 6 months after the operation

  2. POP-Q classification

    examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.

    Time frame: 6 months after the operation

  3. PQOL

    Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.

    Time frame: 6 months after the operation

  4. FSFI

    Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.

    Time frame: 6 months after the operation

  5. 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)

    Time frame: 6 months after the operation

07

Study locations

1 of 1 sites recruiting
  • Zeynep Kamil Maternity and Childrens Training and Research Hospital
    Istanbul, 34660, Turkey
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Oct 2022, 3 months after the start.

Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 3 months is below that.

Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2022
First posted
Sep 28, 2022
StartActual
Jul 15, 2022
Primary completionEst.
Oct 15, 2022
CompletionEst.
Apr 15, 2023
Last update
Sep 30, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05558852
Lead sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible party
Resul Karakuş (Principle Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital) — Principal investigator
First posted
Sep 28, 2022
Start date
Jul 15, 2022
Primary completion
Oct 15, 2022 (estimated)
Completion
Apr 15, 2023 (estimated)
Last update
Sep 30, 2022

Study contacts

Resul Karakus, MD
Contact
resul-karakus@hotmail.com
05059164216

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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