Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05703451
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Prevalence of surgical adhesions among women undergoing laparoscopic surgery at Women's Health Hospital (prospective cross-sectional study).", 'timeFrame': 'baseline', 'description': "the prevalence of surgical adhesions among women undergoing laparoscopy in Women's Health Hospital Assuit University."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Adhesions']}, 'referencesModule': {'references': [{'pmid': '36200671', 'type': 'BACKGROUND', 'citation': 'Aboshama RA, Taha OT, Abdel Halim HW, Elrehim EIA, Kamal SHM, ElSherbiny AM, Magdy HA, Albayadi E, Elsaid RE, Abdelghany AM, Anan MA, Abdelfattah LE. Prevalence and risk factor of postoperative adhesions following repeated cesarean section: A prospective cohort study. Int J Gynaecol Obstet. 2023 Apr;161(1):234-240. doi: 10.1002/ijgo.14498. Epub 2022 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'To assess the prevalence of surgical adhesions among women undergoing laparoscopy, and the severity of the adhesions according to proposed classification of intra-abdominal adhesions.', 'detailedDescription': "Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause. After the patients has been examined and put on a list for laparoscopy, they will be counselled about our study and its benefits. Written consent will be obtained.\n\nAll women will be subjected to the following:\n\n1. History taking:\n\n 1. Personal history: demographic factors and age.\n 2. Obstetric history: parity, last delivery, history of abortion.\n 3. Menstrual history: regular or irregular cycles, P/C.\n 4. Past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and PID.\n 5. Surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section.\n 6. The complain of the patient and the indication of laparoscopy.\n2. Clinical examination:\n\n * General examination including pulse, blood pressure, temperature, BMI and pallor.\n * Abdominal examination for scars of previous operations or fundal level.\n3. Investigations:\n\n * Ultrasonography: to assess the uterus and adnexa.\n * Blood sample: it will be examined for the following; complete blood picture and renal function test.\n4. During laparoscopy:\n\n Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history.\n\n The prevalence of adhesions will be calculated according to the indication of laparoscopy.\n\n The prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history.\n\n Comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy.\n\n Comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery.\n5. The adhesions will be noticed, its site will be detected (between uterus and bladder, uterus and abd. Fascia, uterus and omentum, omentum and abd. Fascia or adhesions to other pelvic structure that interfere with the delivery), its consistency (Filmy or dense) and thickness (either \\< 3cm, 3-6cm, or \\> 6cm) and these informations will be subjected to the proposed classification and every case will have its score. The data will be analysed to find out which cases have high score and their common risk factors that are expected to be the cause of this high score."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who will undergo laparoscopic surgery at Women's Health hospital Assuit University.\n\nwomen aged 18 years or more.\n\nExclusion Criteria:\n\n* Women who refused to participate in our study"}, 'identificationModule': {'nctId': 'NCT05703451', 'briefTitle': "Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital", 'orgStudyIdInfo': {'id': 'surgical adhesions'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopic surgery', 'type': 'OTHER', 'description': 'during laparoscopy Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history.\n\nThe prevalence of adhesions will be calculated according to the indication of laparoscopy.\n\nThe prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history.\n\nComparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy.\n\nComparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Asyut', 'country': 'Egypt', 'facility': "Women's Health Hospital", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Mahmoud Shaban Mohammed Farghaly', 'investigatorAffiliation': 'Assiut University'}}}}