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

December 31, 2020 updated by: Şerif AKSİN, Diyarbakir Women's and Children's Diseases Hospital

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

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.)

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 .

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who underwent surgical prolapse uteri operation in our hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age > 70 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: medical examination
medical examination
Other Names:
  • Routine gynecological examination for POP-Q
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.
Diagnostic test: medical examination
medical examination
Other Names:
  • Routine gynecological examination for POP-Q
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.
Diagnostic test: medical examination
medical examination
Other Names:
  • Routine gynecological examination for POP-Q

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life
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
measures the effect of changes in pelvic organ prolapse on quality of life
12 months after intervention
Change from baseline Visual Analog Score (VAS) for pain
Time Frame: 12 months after intervention
Participant describes the pain related to the mesh
12 months after intervention
Failure (%)
Time Frame: 12 months after intervention
Recurrence rate
12 months after intervention
Complications
Time Frame: 12 months after intervention
İnjury
12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diyarbakir Women's and Children's Diseases Hospital

Investigators

  • Principal Investigator: Şerif Aksin, yes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiyarbakirWCDH 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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