- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07596498
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy in Treatment of Apical Prolapse
Pelvic organ prolapse, particularly apical prolapse, is a common condition among aging women, and laparoscopic sacrocolpopexy is considered the standard surgical treatment due to its high anatomical success. However, it poses technical challenges and risks related to sacral dissection.
Laparoscopic pectopexy, a newer technique using the iliopectineal ligament for mesh fixation, offers a safer anatomical route with shorter operative time and fewer complications. The previous studies evaluate the sacrocolpopexy and pectopexy are all retrospective. This study is prospective randomized controlled study that adds Comparison on the success rate and learning curve of pectopexy versus sacrocolpopexy .
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Pelvic organ prolapse (POP), particularly apical prolapse, is a prevalent condition that significantly impairs the quality of life in aging women, with a global prevalence ranging from 20% to 65% among those over 50 years of age. It involves the downward displacement of the vaginal apex, uterus, or vaginal vault, and is frequently accompanied by urinary, bowel, and sexual dysfunction. Despite conservative measures, many women with symptomatic POP ultimately require surgical correction to restore pelvic anatomy and function.
Multiple surgical techniques have been developed for apical suspension, including transvaginal approaches (e.g., sacrospinous fixation, high uterosacral ligament suspension), transabdominal techniques, and laparoscopic modalities. Among laparoscopic approaches, sacrocolpopexy (LSC) has long been considered the gold standard due to its superior anatomical outcomes compared to native tissue repair or vaginal mesh-based procedures.
However, it demands advanced laparoscopic skills, has a steep learning curve, and carries a risk of complications such as presacral hemorrhage, mesh erosion, defecation dysfunction, and sacral osteomyelitis.
Laparoscopic sacrocolpopexy involves dissection at the sacral promontory and mesh fixation to the anterior longitudinal ligament. Although it provides excellent long-term anatomical support-with reported objective success rates between 78% and 100%-it is associated with longer operative time and potential injuries to the ureter, bowel, or vessels. Furthermore, the anatomical challenges posed by the sacral promontory, especially in obese patients, can hinder operative safety and efficiency.
Laparoscopic pectopexy, first described by Banerjee and Noé in 2011, is an emerging alternative technique in which the mesh is bilaterally anchored to the iliopectineal (Cooper's) ligaments. This anterior fixation avoids dissection near critical retroperitoneal structures and preserves the posterior pelvic space, thereby reducing the risk of defecation disorders and nerve injury. Pectopexcy an emerging technique offers a potential alternative for apical prolapse repaire .this study aims to compare its efficacy &safety with conventional procedures.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Rafael Elkess Gabriel William, Resident
- Telefonnummer: +201223657844
- E-mail: rafailogebrael@gmail.com
Undersøgelse Kontakt Backup
- Navn: Ahmed Farouk, professor
- Telefonnummer: +201005003309
- E-mail: drfarouk77@gmail.com
Studiesteder
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Abbasia
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Cairo, Abbasia, Egypten
- Rekruttering
- Ain shams university hospital
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Kontakt:
- Hisham Arafa, Lecturer
- Telefonnummer: +201001921334
- E-mail: Hishamarafa1988@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with uterine prolapse with POP-Q stage ≥ III.
- Patients diagnosed with vault vaginal prolapse with POP-Q stage ≥ III.
Exclusion Criteria:
- Patients who refuse to participate in the study.
- Patients who have isolated anterior or posterior vaginal wall prolapse.
- Women who are pregnant or lactating.
- Patients with severe comorbidities, including: Serious heart, liver, kidney, or blood diseases or any condition preventing them from tolerating surgery.
- Women with a desire to conceive.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Laparoscopic Pectopexy
About 15 women patients suffering from apical prolapse and will undergo Laparoscopic Pectopexy and The Pelvic Organ Prolapse Quantification (POP-Q) stages will be evaluated preoperatively.
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to evaluate the effectiveness and learning curve of laparoscopic pectopexy in comparison with laparoscopic sacrocolpopexy for the treatment of apical prolapse performed by the same surgeon.
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Aktiv komparator: Laparoscopic Sacrocolpopexy
About 15 women patients suffering from apical prolapse and will undergo Laparoscopic Sacrocolpopexy.and
The Pelvic Organ Prolapse Quantification (POP-Q) stages will be evaluated preoperatively.
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Laparoscopic Sacrocolpopexy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pain Assessment
Tidsramme: 24 Hours
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To assess the Pain intensity after the operation and the pain will be evaluated using the Visual Analog Scale (VAS) whereas : 0 is no pain, and 10 is worst pain.
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24 Hours
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Number of participants treated
Tidsramme: 6 Months
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Treatment of the female patients whom suffering from Apical Prolapse using laparoscopic pectopexy and laparoscopic sacrocolpopexy
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6 Months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Ahmed Farouk, M.D, Professor of Urology Department of Urology Ain Shams University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Apical Prolapse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Apikalt prolaps
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Fundació Institut de Recerca de l'Hospital de la...Carlos III Health Institute; Ministry of Science and Innovation, SpainAfsluttetProlaps; Kvinde | Prolaps Genital | Prolaps UterovaginalSpanien
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Hospital Mutua de TerrassaGermans Trias i Pujol Hospital; Hospital Arnau de Vilanova; Fundació Institut...RekrutteringProlaps; Kvinde | Prolaps Genital | Prolaps UterovaginalSpanien
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Rennes University HospitalAfsluttet
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Manchester University NHS Foundation TrustRekrutteringProlaps; Kvinde | Prolaps, vaginaltDet Forenede Kongerige
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The Methodist Hospital Research InstituteUkendtProlaps af skedehvælving | Post-hysterektomi vaginal hvælving prolaps | Prolaps, vaginaltForenede Stater
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Clinique Beau SoleilAfsluttet
Kliniske forsøg med Laparoscopic Pectopexy
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Ain Shams Maternity HospitalArmed forces hospital wadi aldwaserAktiv, ikke rekrutterende
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Chung Shan Medical UniversityAktiv, ikke rekrutterendeProlaps af bækkenorganer | Bækkenorganprolaps vaginal kirurgi | Sakrokolpopeksi | PectopexyTaiwan
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ARKSurgicalUkendt
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University Hospital of FerraraAfsluttetKirurgi | Rektal prolaps | Afføringsforstyrrelse | Rectocele; KvindeItalien
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Assiut UniversityRekruttering
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Johns Hopkins UniversityAfsluttetKirurgisk simuleringsuddannelse