Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT05143658
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2021-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective cure rate of prolapse', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'Provided by the patient\'s feeling of the "Absence of a bulge in the vagina"'}, {'measure': 'Objective success', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total'}], 'secondaryOutcomes': [{'measure': 'Prolapse-related Quality of life', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range).\n\nThis will also help us in the follow up visits.'}, {'measure': 'Failure (%)', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'Recurrence rate'}, {'measure': 'Complications', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'İnjury ( bowel, intestinal, blood vessel injuries, mesh erosions)'}, {'measure': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.'}, {'measure': 'Incontinence Impact Questionnaire (IIQ-7)', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'evaluating the impact of urinary incontinence'}, {'measure': 'Pelvic Floor Distress Inventory (PFDI - 20)', 'timeFrame': '[ Time Frame: 12 months after intervention ]', 'description': 'evaluating the bowel, bladder, or pelvic symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pectopexy', 'lateral suspension', 'pelvic organ prolapse', 'uterine sparing', 'laparoscopy'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q \\>2) at 1 year and yearly up to 2 years.', 'detailedDescription': 'Primary and secondary endpoints:\n\nPrimary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.\n\nSecondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.\n\nThe study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.\n\nProject design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse\n\nExclusion Criteria:\n\n* Women not eligible for surgery for medical or anesthesiological reasons\n* Inability to comprehend questionnaires\n* Inability to give informed consent\n* Inability to return for a review\n* Prior laparoscopic prolapse repair\n* Prior vaginal mesh prolapse procedure\n* Severe cardiovascular or respiratory disease\n* Women who don't want uterine preserving surgery\n* Pregnancy\n* Age \\<18 years, Age \\>45 years"}, 'identificationModule': {'nctId': 'NCT05143658', 'briefTitle': 'Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair', 'orgStudyIdInfo': {'id': 'KanuniSSS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Lateral Suspension Group (LLS)', 'description': 'Anterior and apical prolapse repair via LLS', 'interventionNames': ['Procedure: LLS versus LP']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Pectopexy (LP)', 'description': 'Anterior and apical prolapse repair via LP', 'interventionNames': ['Procedure: LLS versus LP']}], 'interventions': [{'name': 'LLS versus LP', 'type': 'PROCEDURE', 'description': 'Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy', 'armGroupLabels': ['Laparoscopic Lateral Suspension Group (LLS)', 'Laparoscopic Pectopexy (LP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34307', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ozan Karadeniz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ozan Karadeniz', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}