Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT05367258
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umbilical Endometriosis: a Comparison of Medical and Surgical Therapy and Pathogenetic Considerations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of patient satisfaction', 'timeFrame': '30 years', 'description': 'a five-level Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied) to evaluate the effectiveness of medical and surgical treatments for umbilical endometriosis.'}, {'measure': "The patient's global condition", 'timeFrame': '30 years', 'description': "Patients' Global Impression of Change (PGIC) scale, a composed of seven levels (greatly improved, much improved, minimally improved, unchanged, minimally worsened, very worsened, greatly worsened) to evaluate the effectiveness of medical and surgical treatments for umbilical endometriosis."}, {'measure': 'Severity of symptoms', 'timeFrame': '30 years', 'description': "Patients' Global Impression of Severity (PGIS) scale, a scale consisting of five levels (none, mild, moderate, severe, very severe)"}, {'measure': 'HADS- Hospital Anxiety and Depression Scale', 'timeFrame': '30 years', 'description': 'The HADS questionnaire is a self-assessment mood scale specifically designed for use in non-psychiatric hospital outpatients to determine states of anxiety and depression. It comprises 14 questions, 7 for the anxiety subscale and 7 for the depression subscale.'}, {'measure': 'The Short Form Survey, SF-12', 'timeFrame': '30 years', 'description': 'The SF-12 health survey, developed from the original SF-36 questionnaire, is a well-known, validated, selfadministered 12-item instrument. It measures health dimensions covering functional status, well-being, and overall health. Information from the 12 items is used to construct Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) measures, with higher scores indicating better health perception.'}], 'secondaryOutcomes': [{'measure': 'Pathogenetic aspects', 'timeFrame': '30 years', 'description': "Study of the pathogenesis on a case-by-case basis depending on the patient's previous physiological and pathological medical history."}, {'measure': 'Comparison between medical and surgical therapy', 'timeFrame': '30 years', 'description': 'Comparison through the degree of patient satisfaction, evaluated with Likert scale (used for 1st primary outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical treatment', 'Medical therapy', 'Satisfaction'], 'conditions': ['Endometriosis of Umbilicus', 'Endometriosis in Scar of Skin', 'Endometriosis-related Pain', 'Endometriosis']}, 'descriptionModule': {'briefSummary': "Endometriosis is the presence of endometrial glands and stroma outside the uterine cavity. About 5% of women of reproductive age suffer from the disease.\n\nThe pelvis is the most frequent site of endometriotic lesion and the most common pelvic localisations are peritoneal, ovarian, and deep infiltrating endometriosis. However, endometriosis can also localize outside the pelvis, for example involving the umbilicus, omentum, appendix, liver, diaphragm, pleura and lungs, vulva, and surgical scars.\n\nThe majority of extrapelvic endometriosis implants are located in the skin, and most of them are of iatrogenic origin, following laparotomy, laparoscopic procedures, and episiotomies; only a minority of cases are of primary origin.\n\nUmbilical endometriosis is a very rare presentation of endometriosis (0.5-1% of cases of extrapelvic endometriosis).\n\nPathogenetic hypotheses of primary umbilical endometriosis include: hematic or lymphatic dissemination of endometrial cells from the peritoneum to the umbilicus through obliterated umbilical arteries; migration of endometrial cells through the venous or lymphatic circulation; metaplasia of urachus remnant or release of endometrial cells that during labor and delivery may contaminate the umbilical cord emergence. Secondary umbilical endometriosis is probably due to the proliferation and subsequent dissemination of iatrogenically implanted endometrial cells in laparotomy or laparoscopic scars. In 20% of cases, umbilical endometriosis is associated with pelvic endometriosis. In these patients, it is probable that endometriotic cells may migrate from the endometriotic implants to the umbilical site.\n\nThis migration process could be favored by fascia defects at the umbilical level. In fact, reports in the literature describe cases of umbilical endometriosis coexisting with umbilical hernia.\n\nThe clinical presentation consists of an umbilical nodule of variable color (red, blue, black, flesh-colored), ranging in size from 0.5 to 3 cm.\n\nPathognomonic symptoms are: bleeding and/or pain in the umbilical site of catamenial type, cutaneous hyperesthesia. Catamenial symptomatology associated with the nodule, which makes the diagnosis easier, is present in only 75% of cases.\n\nIn asymptomatic cases the differential diagnosis of the nodule of umbilical endometriosis is more difficult (hernia, hematoma, cyst, dermatological disorders, tumor metastasis).\n\nInstrumental examinations useful for differential diagnosis and definition of nodule size include soft tissue ultrasound, CT scan and MRI.\n\nDefinitive diagnosis is only by histologic examination of the tissue. Exploratory laparoscopy is not indicated unless concomitant pelvic endometriosis is suspected.\n\nThe recommended treatment of umbilical endometriosis is surgical, consisting of complete removal of the endometriosis nodule, omphalectomy, and subsequent reconstruction of the umbilicus.\n\nRecurrence rates after surgery are around 6% at 12 months in a large Japanese court, with no difference between taking and not taking postoperative hormonal therapy, while they are reduced to almost 0% in case of resection including a large portion of peritoneum.\n\nMedical therapy, on the other hand, alleviates the associated algic symptoms by reducing the size of the nodule.\n\nThere are very few data on the efficacy of medical therapy; in a study with a very small number of cases an efficacy of 91.7% with dienogest and 51.1% with estroprogestinic pill is reported. There are no studies comparing medical and surgical therapy for the treatment of umbilical endometriosis.\n\nRadical excision is recommended to avoid local recurrences and to avoid the risk of malignant transformation, although it is extremely rare (only 2 cases reported).\n\nIn literature, spontaneous resolution has been described in only one pregnant woman.\n\nTo date, few studies have evaluated umbilical endometriosis. Moreover, no study has ever formally compared the long-term efficacy of surgical or medical therapy for umbilical endometriosis.\n\nThis is a observational, retrospective/prospective and monocentric study; it is based on the review of medical records and on outpatient follow-up visits of patients in our clinic with umbilical endometriosis from 1990.\n\nThe principal aim of the study is to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction, psychological state, health-related quality of life of patients suffering from this clinical condition. Moreover, global patient's condition and severity of the patient's symptoms are evaluated The secondary aim is to investigate the pathogenetic aspects of this clinical condition.", 'detailedDescription': "Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity. About 5% of women of reproductive age suffer from the disease.\n\nThe pelvis is the most frequent site of endometriotic lesion and three types of pelvic endometriosis can be clinically distinguished: peritoneal, ovarian, and deep infiltrating endometriosis.\n\nHowever, endometriosis can also localize outside the pelvis: extra-pelvic foci may be found involving the umbilicus, omentum, appendix, liver, diaphragm, pleura and lungs, vulva, and surgical scars.\n\nThe majority of extrapelvic endometriosis implants are located in the skin, and most of them are of iatrogenic origin, following laparotomy, laparoscopic procedures, and episiotomies; only a minority of cases are of primary origin.\n\nUmbilical endometriosis - first described by Villar in 1886 - is a very rare presentation of endometriosis, with a prevalence ranging from 0.5-1% of cases of extrapelvic endometriosis The proliferation and subsequent dissemination of iatrogenically implanted endometrial cells in laparotomy or laparoscopic scars would seem to be the cause of the occurrence of secondary umbilical endometriosis. Obviously this is not true in cases of primary umbilical endometriosis, in which case the pathogenic hypotheses include: hematic or lymphatic dissemination of endometrial cells from the peritoneum to the umbilicus through obliterated umbilical arteries; migration of endometrial cells through the venous or lymphatic circulation; metaplasia of urachus remnant or release of endometrial cells that during labor and delivery may contaminate the umbilical cord emergence. In 20% of cases, umbilical endometriosis is associated with pelvic endometriosis. In these patients, it is possible to speculate that endometriotic cells may migrate from the endometriotic implants to the umbilical site.\n\nThis migration process could be favored by fascia defects at the umbilical level. In fact, cases of umbilical endometriosis coexisting with umbilical hernia are described in the literature.\n\nThe clinical presentation consists of an umbilical nodule of variable color (red, blue, black, flesh-colored), ranging in size from 0.5 to 3 cm.\n\nPathognomonic symptoms are: bleeding and/or pain in the umbilical site of catamenial type, cutaneous hyperesthesia. Catamenial symptomatology associated with the nodule, which makes the diagnosis easier, is present in only 75% of cases.\n\nIn asymptomatic cases the nodule of umbilical endometriosis should be differentially diagnosed with hernia, hematoma or cyst and with some dermatological disorders such as pyogenic granuloma, umbilical polyp, melanocytic nevus, seborrheic keratosis, epithelial inclusion cysts, desmoid tumor, hemangioma and granular cell tumor. Furthermore, it should be ruled out that it is not a Sister Joseph's nodule, a sentinel of tumor metastasis, whose clinical symptomatology is similar to umbilical endometriosis, although the nodule tends to be more irregular and the symptoms non-cyclic. A case of umbilical metastasis from endometrial carcinoma, synchronous with umbilical endometriosis, is reported.\n\nInstrumental examinations useful for differential diagnosis and definition of nodule size include soft tissue ultrasound, CT scan, and MRI.\n\nDefinitive diagnosis is provided only by histologic examination of the tissue. Exploratory laparoscopy is not indicated unless concomitant pelvic endometriosis is suspected.\n\nThe recommended treatment of umbilical endometriosis is surgical, consisting of complete removal of the endometriosis nodule, omphalectomy, and subsequent reconstruction of the umbilicus.\n\nRecurrence rates after surgery are around 6% at 12 months in a large Japanese court, with no difference between taking and not taking postoperative hormonal therapy, while they are reduced to almost 0% in case of resection including a large portion of peritoneum.\n\nMedical therapy, on the other hand, alleviates the associated algic symptoms by reducing the size of the nodule.\n\nIn the literature there are very few data on the efficacy of medical therapy; in a study with a very small number of cases an efficacy of 91.7% with dienogest and 51.1% with estroprogestinic pill is reported. There are no studies comparing medical and surgical therapy for the treatment of umbilical endometriosis.\n\nRadical excision is recommended to avoid local recurrences and to avoid the risk of malignant transformation, although it is extremely rare (only 2 cases reported in the literature).\n\nIn literature, spontaneous resolution has been described in only one pregnant woman.\n\nTo date, there are few studies in the literature that have evaluated umbilical endometriosis.\n\nMoreover, no study has ever formally compared the long-term efficacy of surgical or medical therapy for umbilical endometriosis.\n\nThis is an observational, retrospective/prospective and monocentric study; it is based on the review of medical records and on outpatient follow-up visits of patients in our clinic with umbilical endometriosis. This is a study design that it is best suited to a low prevalence of disease.\n\nThe principal aim of the study is the assessment of umbilical endometriosis cases in our clinic over the last 30 years in order to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction, psychological state, health-related quality of life of patients suffering from this clinical condition. Moreover, global patient's condition and severity of the patient's symptoms are evaluated.\n\nThe secondary aim is to investigate the pathogenetic aspects of this clinical condition."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients referred to our endometriosis clinic and/or underwent surgery from 1 January 1990 to 01 March 2022 with a diagnosis of umbilical endometriosis were selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 18-50 years with a diagnosis of umbilical endometriosis, in the presence or absence of other endometriotic localizations, referred to our tertiary-care endometriosis center " Fondazione IRCCS Ospedale Maggiore Policlinico", Milan, from 1 January 1990 to 01 March 2022.\n\nExclusion Criteria:\n\n* Exclusion criteria are the presence of concomitant psychiatric disease, chronic intestinal disease (Chron\'s disease or ulcerative rectocolitis), or disease that may cause pelvic pain (e.g., pelvic venous varices and salpingitis outcomes).'}, 'identificationModule': {'nctId': 'NCT05367258', 'acronym': 'UMBEND', 'briefTitle': 'Umbilical Endometriosis: a Comparison of Medical and Surgical Therapy and Pathogenetic Considerations', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Umbilical Endometriosis: a Comparison of Medical and Surgical Therapy and Pathogenetic Considerations', 'orgStudyIdInfo': {'id': '2283'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients satisfaction after medical and surgical treatment for umbilical endometriosis', 'type': 'OTHER', 'description': 'It is a retrospectively evaluation of cases of umbilical endometriosis in our clinic over the last 30 years, based on the review of medical records and on outpatient follow-up visits. The questionnaire are filled in routinely by patients attending the endometriosis center of this institute every 6 months. We will collect data relating to these questionnaires referring prospectively to the study period. If the questionnaires have not already been filled in by the patient, she will be contacted to fill them in, after signing the informed consent of the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Berlanda, Prof', 'role': 'CONTACT', 'email': 'nicola.berlanda@policlinico.mi.it', 'phone': '0255032318'}], 'facility': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Nicola Berlanda, Professor', 'role': 'CONTACT', 'email': 'nicola.berlanda@policlinico.mi.it', 'phone': '0255032318'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Nicola Berlanda', 'investigatorFullName': 'Direzione Ginecologia', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}