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Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.
After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Pectopexy without mesh | Experimental | In this group of patients, the Laparoscopic Pectopexy operation will be performed without the use of mesh material after hysterectomy. Not using mesh will be protective against possible erosion reactions that may develop in the postoperative period. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture. |
|
| Laparoscopic Pectopexy with mesh | Active Comparator | In this group of patients, the Laparoscopic Pectopexy operation will be performed using mesh material after hysterectomy. Laparoscopic hysterectomy is performed using the standard procedure with a uterine manipulator; after sealing the uterine arteries, the vagina is cut at the level of the uterine manipulator cuff and sutured. The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meshless Laparoscopic Pectopexy | Procedure | The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apical descensus relapse rate | The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolapse Quality of Life (P-QOL) | The questionnaire has nine items, each of which has a 4-point scoring system and a total score of 0-100. A high total score indicates worsening of the quality of life of women with pelvic organ prolapse. | Preoperative day and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| De novo central or lateral defect cystocele rate | The ratio of women with stage 2 or greater central or lateral defect cystocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system | 12 months after surgery |
| De novo rectocele rate |
Inclusion Criteria:
Exclusion Criteria:
Female patients with symptomatic uterine prolapse
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Şener Gezer, M.D. | Contact | +903723037575 | dr.senergezer@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| İsmail Bıyık, M.D. | Kütahya Sağlık Bilimleri University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University, School of Medicine | Recruiting | Köseköy | Kocaeli | 41380 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167602 | Background | Erdem B, Salman S, Usta ZK, Bacak HB, Ozkan MD, Ceken AT, Isik EY, Kumbasar S, Gencer FK, Baghaki HS, Kacar T, Aslan GN, Bulut B. A Novel Approach for Apical Prolapse Surgery: Meshless Pectopexy (Salman's Modification). Int Urogynecol J. 2025 Aug;36(8):1701-1705. doi: 10.1007/s00192-025-06107-z. Epub 2025 Apr 1. | |
| 34184848 | Background |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Laparoscopic Pectopexy with mesh | Procedure | The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh. |
|
The ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system
| 12 months after surgery |
| Aleksandrov A, Smith AV, Rabischong B, Botchorishvili R. Mesh-less laparoscopic treatment of apical prolapse. Facts Views Vis Obgyn. 2021 Jun;13(2):179-181. doi: 10.52054/FVVO.13.2.013. |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |