Pelvic Organ ProlapseNCT04178083

Comparison of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy.

An observational study of Pelvic Organ Prolapse and Laparoscopy, run by Diyarbakir Women's and Children's Diseases Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between January 2017 and December 2019 in our clinic.(Patients with at least 12 months of the date of surgery will be called for examination.) Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Pelvic Organ Prolapse, Laparoscopy
What is being tested?: medical examination
How many people: 120 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2020to 30 Dec 2020
Phase: Observational
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 18 to 70 years
Women only
Adult, Older adult

Study population: patients who underwent surgical prolapse uteri operation in our hospital

Who may be able to join

patients requiring surgical treatment for the symptomatic stage of pelvic organ prolapse ≥ 2

Who cannot join

Age > 70 years
Severe cardiovascular or respiratory disease
Pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Diyarbakır Women's and Children's Hospital
Diyarbakır, 21100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Postoperative Results of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy in Patients With Uterine Prolapse.

Read the detailed description

We will evaluate Pelvic Organ Prolapse Quantitative System (POP-Q), Prolapse Quality of Life Questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS), Visual Analogue Score (VAS), routine gynecologic USG, failure, complication, operation time .

Conditions: Pelvic Organ Prolapse, Laparoscopy
Being tested: medical examination
Keywords: laparoscopy, pelvic organ prolapse, modified lateral süspension, pectopexy, sacrohysteropexy, hysteropexy, sacropexy, cervicopexy, sacrocervicopexy
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.

medical examinationDiagnostic test
Also called Routine gynecological examination for POP-Q
medical examination

Study groups in NCT04178083
Study group	Role	What they receive
Laparoscopic Sacrohysteropexy,		Under general anesthesia,laparoscopic approach is used to enter the abdomen.Following this, visceral peritoneum is held with forceps from the point where the sacro-uterine ligaments adhere to the uterus. cut with unipolar scissors to the sacrouterin ligaments approximately 2-4 cm in the midline a transverse incision is made and the posterior wall of the cervix is reached. Approx. 10-15 x2 cm polypropylene mesh 5 mm trocar is inserted into the abdomen with the help of grasper and one end three points with 2/0 non-absorbable prolene sutures in the midline cervix Intracorporeal suture technique. After the sacral promontorium on peritona about 2 The transverse incision is made to the normal anatomical position and the appropriate mesh length is determined and the other end is fixed to the area prepared on the sacral promontorium at 3 points with 2-0 prolene. Bleeding reperitonization according to intracorporeal suture technique with 2/0 vicry Receives: Diagnostic Test: medical examination
Modified Laparoscopic Lateral Suspension		A 10 cm diameter trocar is passed through a 1 cm infraumbical incision. In addition, two 5 mm diameter trocar are placed on 4 cm on both sides of the spinal iliac crest, and a 5 mm diameter trocar is placed laterally in the rectus muscle at the left lateral level of the umbilicus. A Prolene network of 25 cm in length is prepared. Dissection of the uterine cavity is performed to expose a mustache. The bottom of the web is secured by suturing the web in the midline and sides of the web with 2-0 prolene. The left and right modified lateral ports are then removed by moving under the bottom of the planet with the help of the planet until the isthmus reaches the bottom of the round ligament. The lateral ports are again slid onto the mesh, placed and sutured with peritoneal 2-0 vicryil, the mesh ends are cut at the skin level and the procedure is terminated. Receives: Diagnostic Test: medical examination
Laparoscopic Pectopexy		First, the peritoneal layer on the top and side of the bladder opens parallel to the round ligament toward the right pelvic sidewall. The iliopectineal ligament is then located under the guidance of the obliterated umbilical artery, lateral to the obliterated umbilical artery and medially of the outer iliac vein. iliopectineal (Cooper) ligament exposing a segment of approximately 3-4 cm is formed. After completion of the dissections, the ends of the mesh are sutured to both iliopectineal ligaments by intracorporeal suture using nonabsorbable sutures. The middle of the net is fixed with three sutures to the lower anterior segment of the uterus. The peritoneum on the mesh is sutured with an absorbable suture material. Receives: Diagnostic Test: medical examination

What is being measured

The primary outcome is the main question the study is designed to answer.

Anatomical improvement according to POP-Q score
a system for assessing the degree of prolapse of pelvic organs
Measured: 12 months after intervention

Secondary outcomes (5)

Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse
The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life
Measured: 12 months after intervention
Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse
measures the effect of changes in pelvic organ prolapse on quality of life
Measured: 12 months after intervention
Change from baseline Visual Analog Score (VAS) for pain
Participant describes the pain related to the mesh
Measured: 12 months after intervention
Failure (%)
Recurrence rate
Measured: 12 months after intervention
Complications
İnjury
Measured: 12 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202030 Dec 2020

First posted26 Nov 2019
Study start1 Jan 2020
Primary completion30 Dec 2020
Study completion30 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04178083
Sponsor's protocol ID: DiyarbakirWCDH 2
Status last verified: Dec 2020
First submitted: 24 Nov 2019
Last updated: 5 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.
PubMed 28417156
Bojahr B, Tchartchian G, Waldschmidt M, Ohlinger R, De Wilde RL. Laparoscopic sacropexy: a retrospective analysis of the subjective outcome in 310 cases. Obstet Gynecol Int. 2012;2012:538426. doi: 10.1155/2012/538426. Epub 2011 Sep 7.
PubMed 21912552
Noe KG, Schiermeier S, Alkatout I, Anapolski M. Laparoscopic pectopexy: a prospective, randomized, comparative clinical trial of standard laparoscopic sacral colpocervicopexy with the new laparoscopic pectopexy-postoperative results and intermediate-term follow-up in a pilot study. J Endourol. 2015 Feb;29(2):210-5. doi: 10.1089/end.2014.0413. Epub 2014 Nov 20.
PubMed 25350228

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Recruiting
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Postoperative Results of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy in Patients With Uterine Prolapse.
ClinicalTrials.gov ID: NCT04178083
Acronym / sponsor ID: DiyarbakirWCDH 2
Conditions: Pelvic Organ Prolapse, Laparoscopy
Keywords: laparoscopy, pelvic organ prolapse, modified lateral süspension, pectopexy, sacrohysteropexy, hysteropexy, sacropexy, cervicopexy
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Diyarbakir Women's and Children's Diseases HospitalUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 30 Dec 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 26 Nov 2019 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Laparoscopic Sacrohysteropexy,	–	Diagnostic Test: medical examinationUnder general anesthesia,laparoscopic approach is used to enter the abdomen.Following this, visceral peritoneum is held with forceps from the point where the sacro-uterine ligaments adhere to the uterus. cut with unipolar scissors to the sacrouterin ligaments approximately 2-4 cm in the midline a transverse incision is made and the posterior wall of the cervix is reached. Approx. 10-15 x2 cm polypropylene mesh 5 mm trocar is inserted into the abdomen with the help of grasper and one end three points with 2/0 non-absorbable prolene sutures in the midline cervix Intracorporeal suture technique. After the sacral promontorium on peritona about 2 The transverse incision is made to the normal anatomical position and the appropriate mesh length is determined and the other end is fixed to the area prepared on the sacral promontorium at 3 points with 2-0 prolene. Bleeding reperitonization according to intracorporeal suture technique with 2/0 vicry
Modified Laparoscopic Lateral Suspension	–	Diagnostic Test: medical examinationA 10 cm diameter trocar is passed through a 1 cm infraumbical incision. In addition, two 5 mm diameter trocar are placed on 4 cm on both sides of the spinal iliac crest, and a 5 mm diameter trocar is placed laterally in the rectus muscle at the left lateral level of the umbilicus. A Prolene network of 25 cm in length is prepared. Dissection of the uterine cavity is performed to expose a mustache. The bottom of the web is secured by suturing the web in the midline and sides of the web with 2-0 prolene. The left and right modified lateral ports are then removed by moving under the bottom of the planet with the help of the planet until the isthmus reaches the bottom of the round ligament. The lateral ports are again slid onto the mesh, placed and sutured with peritoneal 2-0 vicryil, the mesh ends are cut at the skin level and the procedure is terminated.
Laparoscopic Pectopexy	–	Diagnostic Test: medical examinationFirst, the peritoneal layer on the top and side of the bladder opens parallel to the round ligament toward the right pelvic sidewall. The iliopectineal ligament is then located under the guidance of the obliterated umbilical artery, lateral to the obliterated umbilical artery and medially of the outer iliac vein. iliopectineal (Cooper) ligament exposing a segment of approximately 3-4 cm is formed. After completion of the dissections, the ends of the mesh are sutured to both iliopectineal ligaments by intracorporeal suture using nonabsorbable sutures. The middle of the net is fixed with three sutures to the lower anterior segment of the uterus. The peritoneum on the mesh is sutured with an absorbable suture material.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Age groups: Adult, Older adult
Study population: patients who underwent surgical prolapse uteri operation in our hospital

Key inclusion criteria (1 listed)

patients requiring surgical treatment for the symptomatic stage of pelvic organ prolapse ≥ 2

Key exclusion criteria (3 listed)

Age > 70 years
Severe cardiovascular or respiratory disease
Pregnancy

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
medical examinationAlso: Routine gynecological examination for POP-Qmedical examination	Diagnostic test	Laparoscopic Pectopexy, Laparoscopic Sacrohysteropexy,, Modified Laparoscopic Lateral Suspension

Primary outcome

Anatomical improvement according to POP-Q score
Time frame: 12 months after intervention
a system for assessing the degree of prolapse of pelvic organs

5 secondary outcomes

Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse
Time frame: 12 months after intervention
Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse
Time frame: 12 months after intervention
Change from baseline Visual Analog Score (VAS) for pain
Time frame: 12 months after intervention
Failure (%)
Time frame: 12 months after intervention
Complications
Time frame: 12 months after intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Background: PubMed 28417156Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.
Background: PubMed 21912552Bojahr B, Tchartchian G, Waldschmidt M, Ohlinger R, De Wilde RL. Laparoscopic sacropexy: a retrospective analysis of the subjective outcome in 310 cases. Obstet Gynecol Int. 2012;2012:538426. doi: 10.1155/2012/538426. Epub 2011 Sep 7.
Background: PubMed 25350228Noe KG, Schiermeier S, Alkatout I, Anapolski M. Laparoscopic pectopexy: a prospective, randomized, comparative clinical trial of standard laparoscopic sacral colpocervicopexy with the new laparoscopic pectopexy-postoperative results and intermediate-term follow-up in a pilot study. J Endourol. 2015 Feb;29(2):210-5. doi: 10.1089/end.2014.0413. Epub 2014 Nov 20.
Individual participant dataSharing planned: Undecided

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Recruiting
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Not yet recruiting
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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.

Şerif Aksin principal investigator

Yes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse and Laparoscopy, run by Diyarbakir Women's and Children's Diseases 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jan 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anatomical improvement according to POP-Q score (time frame: 12 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178083, which also lists 3 linked publications.

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 5 Jan 2021.