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

NCT ID: NCT04178083

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-12-30

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 .

Conditions

Pelvic Organ Prolapse; Laparoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

medical examination

Intervention Type: 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.

medical examination

Intervention Type: 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.

medical examination

Intervention Type: DIAGNOSTIC_TEST

medical examination

Interventions

medical examination

medical examination

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Routine gynecological examination for POP-Q

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Diyarbakir Women's and Children's Diseases Hospital

OTHER

Sponsor Role: lead

Responsible Party

Şerif AKSİN

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şerif Aksin

Role: PRINCIPAL_INVESTIGATOR

Yes

Locations

Diyarbakır Women's and Children's Hospital

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28417156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21912552 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25350228 (View on PubMed)

Other Identifiers

DiyarbakirWCDH 2

Identifier Type: -

Identifier Source: org_study_id