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

Sponsor
Diyarbakir Women's and Children's Diseases Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04178083
Collaborator
(none)
120
1
12
10

Study Details

Study Description

Brief 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.)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: medical examination

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 Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Postoperative Results of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy in Patients With Uterine Prolapse.
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Anatomical improvement according to POP-Q score [12 months after intervention]

      a system for assessing the degree of prolapse of pelvic organs

    Secondary Outcome Measures

    1. Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse [12 months after intervention]

      The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life

    2. Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse [12 months after intervention]

      measures the effect of changes in pelvic organ prolapse on quality of life

    3. Change from baseline Visual Analog Score (VAS) for pain [12 months after intervention]

      Participant describes the pain related to the mesh

    4. Failure (%) [12 months after intervention]

      Recurrence rate

    5. Complications [12 months after intervention]

      İnjury

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diyarbakır Women's and Children's Hospital Diyarbakır Turkey 21100

    Sponsors and Collaborators

    • Diyarbakir Women's and Children's Diseases Hospital

    Investigators

    • Principal Investigator: Şerif Aksin, Yes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Şerif AKSİN, Medical Doctor, Diyarbakir Women's and Children's Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT04178083
    Other Study ID Numbers:
    • DiyarbakirWCDH 2
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Şerif AKSİN, Medical Doctor, Diyarbakir Women's and Children's Diseases Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2021