Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-27 @ 12:24 AM
Study NCT ID:
NCT04817150
Status:
UNKNOWN
Last Update Posted:
2021-04-19
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020047', 'term': 'Rectocele'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D012005', 'term': 'Rectal Prolapse'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes are assessed by 2 independent blinded coloproctologists'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a prospective randomized comparative study in parallel groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': 'intraoperatively', 'description': 'intraoperative blood loss (ml)'}, {'measure': 'length of hospital stay', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'length of hospital stay (days)'}, {'measure': 'postop pain severity', 'timeFrame': '24 hours postop', 'description': 'VAS (Visual Analog Scale)'}, {'measure': 'postop stress urinary incontinence', 'timeFrame': '12 months', 'description': 'Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)'}, {'measure': 'complications rate', 'timeFrame': '12 months', 'description': 'early and remote complications'}, {'measure': "surgeon's tiredness", 'timeFrame': '1 hour after the surgery', 'description': 'Profile of Mood States Questionnaire'}, {'measure': 'postoperative seroma/hematoma volume', 'timeFrame': '3 weeks', 'description': 'size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml)'}, {'measure': 'postop pain syndrom duration', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pain medications consumption'}], 'primaryOutcomes': [{'measure': 'objective cure rate', 'timeFrame': '12 months postop', 'description': 'objective cure rate according to clinical POP-Q assesment'}], 'secondaryOutcomes': [{'measure': 'obstructive defecation cure', 'timeFrame': '12 months postop', 'description': 'according to Wexner scale score (Cleveland Clinic Constipation Scoring System, scale of 0-30, with 0 = minimum, healthy individual and 30 = maximum, severe obstructive defecation)'}, {'measure': 'incontinence cure', 'timeFrame': '12 months postop', 'description': 'according to Cleveland Clinic scale score (Cleveland Clinic Incontinence Scoring System, scale of 0-20, with 0 = minimum, perfect continence and 20 = maximum, complete incontinence)'}, {'measure': "patient's satisfaction", 'timeFrame': '12 months postop', 'description': 'according to PGII (Patient Global Impression of Improvement) questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectocele; Female', 'Rectocele and Incomplete Uterine Prolapse', 'Rectocele and Complete Uterovaginal Prolapse', 'Rectal Prolapse']}, 'descriptionModule': {'briefSummary': "The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse.\n\nThis is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q \\[pelvic organ prolapse quantification\\] grade) and/or full-thickness rectal prolapse.\n\nIntervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed.\n\nThe specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse\n* age 18-70 y.o.\n\nExclusion Criteria:\n\n* severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV),\n* ongoing oncological diseases,\n* ongoing hematological diseases,\n* ongoing inflammatory diseases of the colon and pelvic organs,\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04817150', 'acronym': 'LARC', 'briefTitle': '3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study', 'organization': {'class': 'OTHER', 'fullName': 'Private Healthcare Institution Clinical Hospital RGD-Medicine'}, 'officialTitle': 'LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.', 'orgStudyIdInfo': {'id': 'LARC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D-laparoscopy', 'description': 'patients who underwent 3D laparoscopic ventral rectopexy', 'interventionNames': ['Procedure: Laparoscopic ventral mesh rectopexy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2D-laparoscopy', 'description': 'patients who underwent conventional 2D laparoscopic ventral rectopexy', 'interventionNames': ['Procedure: Laparoscopic ventral mesh rectopexy']}], 'interventions': [{'name': 'Laparoscopic ventral mesh rectopexy', 'type': 'PROCEDURE', 'description': "Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore", 'armGroupLabels': ['2D-laparoscopy', '3D-laparoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '344010', 'city': 'Rostov-on-Don', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Anastasiya Golovina, Dr', 'role': 'CONTACT', 'email': 'a_anastacia@icloud.com', 'phone': '+79518319720'}], 'facility': 'Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}], 'centralContacts': [{'name': 'Anastasiya Golovina', 'role': 'CONTACT', 'email': 'a_anastacia@icloud.com', 'phone': '+79518319720'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexander Khitaryan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alexander Khitaryan', 'investigatorAffiliation': 'Private Healthcare Institution Clinical Hospital RGD-Medicine'}}}}