Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT03206892
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'using sequentially numbered, opaque sealed enveloped; each envelope contains the method of intervention according to the random sequence and will be opened just before the intervention.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'women fulfilled the inclusion criteria and consented will be included in the study and randomly assigned into two groups using computer random sequence generator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful surgical procedure', 'timeFrame': '1 hour (minutes)', 'description': 'without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '1 hour (minutes)', 'description': 'from trocar insertion to last skin stitch (minutes)'}, {'measure': 'intraoperative blood loss', 'timeFrame': '24 hour after end of procedure', 'description': 'amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)'}, {'measure': 'intraoperative complications', 'timeFrame': '1 hour', 'description': 'blood transfusion (number of units), bowel, bladder or ureteric injuries'}, {'measure': 'postoperative hospital stay', 'timeFrame': '3 days', 'description': 'number of days'}, {'measure': 'postoperative pain', 'timeFrame': '1st day', 'description': 'visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed'}, {'measure': 'postoperative complications', 'timeFrame': '1st week', 'description': 'hematoma, wound infection, ileus, UTI'}, {'measure': 'cosmetic outcome', 'timeFrame': 'day 1 and day 7', 'description': 'scar image'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LESS surgery', 'conventional multi-port laparoscopy', 'SILS', 'Single-site surgery', 'Covidien', 'laparoscopy', 'minimally invasive surgery', 'ovarian drilling', 'PCOS', 'Diagnostic laparoscopy'], 'conditions': ['Successful Surgical Procedure', 'Operative Time', 'Cosmetic Outcome', 'Intra- and Post- Operative Complications']}, 'descriptionModule': {'briefSummary': 'laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects', 'detailedDescription': 'Laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS according to Rotterdam Criteria (2 out of 3):\n* polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume \\>10 cm3).\n* oligo- or an-ovulation.\n* clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles.\n* Indications of laparoscopic ovarian drilling:\n* clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles.\n* other indications for laparoscopy.\n* before gonadotropin administration to decrease risk of OHSS and multiple pregnancy.\n* before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.\n\nExclusion Criteria:\n\n* previous 2 or more laparotomies.\n* chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain.\n* High BMI (\\>35kg/m2)\n* do not possess a native umbilicus.\n* advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy).\n* contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.'}, 'identificationModule': {'nctId': 'NCT03206892', 'briefTitle': 'LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LESS surgery AinShamsMH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LESS surgery', 'description': 'Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique).', 'interventionNames': ['Device: laparoscopic ovarian drilling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional multi-port laparoscopy', 'description': 'laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using conventional multi-port laparoscopy (three port system using a closed technique on the umbilicus, left and right lower quadrant areas).', 'interventionNames': ['Device: laparoscopic ovarian drilling']}], 'interventions': [{'name': 'laparoscopic ovarian drilling', 'type': 'DEVICE', 'description': 'laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy', 'armGroupLabels': ['LESS surgery', 'conventional multi-port laparoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hesham M. Fathy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Ahmed M. Bahaa Eldin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Haitham Fathy M., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Maya M. AbdelRazek, M. Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Ahmed Mohamed Bahaa Eldin Ahmed', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}