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

Completed

• Conditions: Pelvic Organ Prolapse; Laparoscopy
• Interventions: Diagnostic Test: medical examination

• Registration Number: NCT04178083
• Lead Sponsor: Diyarbakir Women's and Children's Diseases Hospital

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.)

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 Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2020-01-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic Sacrohysteropexy,	medical examination	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
Modified Laparoscopic Lateral Suspension	medical examination	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.
Laparoscopic Pectopexy	medical examination	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Change from baseline Visual Analog Score (VAS) for pain	12 months after intervention	Participant describes the pain related to the mesh
Failure (%)	12 months after intervention	Recurrence rate
Complications	12 months after intervention	İnjury

Trial Locations

Locations (1)

Diyarbakır Women's and Children's Hospital; 🇹🇷 Diyarbakır, Turkey