Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-04-10 @ 2:45 AM
Study NCT ID:
NCT01556204
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2012-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'falcont@ccf.org', 'phone': '216-444-1752', 'title': 'Tommaso Falcone, M.D.', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Robotic Surgery', 'description': 'da Vinci Surgical System\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Laparoscopy', 'description': 'Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Surgery', 'description': 'da Vinci Surgical System\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}, {'id': 'OG001', 'title': 'Laparoscopy', 'description': 'Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}], 'classes': [{'categories': [{'measurements': [{'value': '106.6', 'spread': '48.8', 'groupId': 'OG000'}, {'value': '101.6', 'spread': '63.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This p-value is from a single comparison between two arms for operative time.', 'groupDescription': 'Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1st 24 hours', 'description': 'Operative time is defined as skin incision to skin closure.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Surgery', 'description': 'da Vinci Surgical System\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}, {'id': 'OG001', 'title': 'Laparoscopy', 'description': 'Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.2', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': '6-weeks', 'categories': [{'measurements': [{'value': '28.6', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'categories': [{'measurements': [{'value': '24.8', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '23.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This applies to Row title: Baseline', 'groupDescription': 'Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This applies to Row title: 6-weeks', 'groupDescription': 'Pain scores at 6 weeks comparison between robotic and laparoscopy.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This applies to Row title: 6-months', 'groupDescription': 'Pain scores at 6 months for robotic vs laparoscopy.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6-weeks, 6-months', 'description': 'Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Robotic Surgery', 'description': 'da Vinci Surgical System\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}, {'id': 'FG001', 'title': 'Laparoscopy', 'description': 'Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.\n\nSurgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Robotic', 'description': 'Robotic surgery'}, {'id': 'BG001', 'title': 'Laparoscopic', 'description': 'Laparoscopic surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2012-03-13', 'resultsFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-23', 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': '1st 24 hours', 'description': 'Operative time is defined as skin incision to skin closure.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline, 6-weeks, 6-months', 'description': 'Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometriosis'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '28238489', 'type': 'DERIVED', 'citation': 'Soto E, Luu TH, Liu X, Magrina JF, Wasson MN, Einarsson JI, Cohen SL, Falcone T. Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a multicenter, randomized, controlled trial. Fertil Steril. 2017 Apr;107(4):996-1002.e3. doi: 10.1016/j.fertnstert.2016.12.033. Epub 2017 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.', 'detailedDescription': "This is a prospective randomized control trial. Study subjects will be recruited from patients that present to the Department of Gynecology who are to have surgery for endometriosis at the Cleveland Clinic.\n\nPatient that require bowel resection and/or ureteral reanastomosis are not included due to the fact that these events impact operating time significantly and are not commonly performed as part of endometriosis surgery (subjects may not be equally distributed among both arms).\n\nEligible patients that agree to participate will be provided written informed consent administered by the collaborators listed on this Institutional Review Board (IRB) at the above clinic locations. In addition to a standardized evaluation including the history and physical examination, the patients will complete the validated health-related quality of life questionnaires SF-12 and Endometriosis Health Profile-30 (EHP-30) with additional questions to determine baseline pain and activity scales as well as daily pain medication use.\n\nSurgeries will be performed by two board certified gynecologic surgeons (TF and JG). JG will participate in the laparoscopic arm of the study (Beachwood Family Health and Surgery Center) while TF will participate in both arms (Cleveland Clinic main campus). The patients of JG randomized to robotic surgery will be performed by TF at Cleveland Clinic main campus.\n\nAdditionally, after the surgery, the patients will complete the above questionnaires as well as diaries addressing narcotic use and quality of life at 6 weeks and 6 months. Completion of questionnaires and diaries is the only additional assessment that is specific to participation in this study that is not usually included as part of the standard care for the treatment of endometriosis. It should take no more than 10 minutes to complete the questionnaires and less than 5 minutes each day to complete the diaries. The study subjects will not be exposed to any additional risk by participating in this study except for the inconvenience of completing the questionnaires and daily diaries.\n\nThe participants will be randomized preoperatively (at the time of surgery scheduling) according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package (SAS Institute, Cary, NC). All patients will be blinded to their assignment. Intraoperative randomization of the patients is not feasible due to the fact that the operating room staff and operating room assigned for a given case is different for robotic and traditional laparoscopic cases.\n\nPatients who do not choose to participate in this study will still be offered the standard evaluation and management including laparoscopic treatment of endometriosis as deemed appropriate by the primary surgeon. Robotic-assisted laparoscopic treatment of endometriosis is not routinely performed in this institution however, and thus is not considered part of the standard of care.\n\nLaparoscopic assisted resection of endometriosis will be performed using up to five 5mm. ports. An umbilical port will be placed for the laparoscope and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using up to five ports as needed. An umbilical port will be placed for the laparoscope (10/12mm), a 5mm assistant port will be placed in the right lower quadrant and two or three 8 mm robotic ports will be placed in the lower quadrants bilaterally.\n\nThe technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).\n\nPatients that are found not to have endometriosis at the time of surgery will be excluded from the study. The robot will be docked for all cases assigned for this arm irrespective of the amount of disease encountered (including mild endometriosis).\n\nData points recorded during the procedure will include: operating room time of entry and exit and time from incision to closure. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital (in cases that warrant admission) will be calculated. The standard American Society of Reproductive Medicine (ASRM) intraoperative endometriosis scoring system will be documented at the end of each surgery. Procedure and inpatient hospital costs (if applicable) will also be determined. All the operating room data (including the primary outcome) will be collected by a research nurse or coordinator that will be assigned for this task (to optimize reliability of these measurements).\n\nPatients will complete their daily narcotic use, which will include oral as well as patient-controlled analgesia IV narcotic use in the hospital when applicable as well as quality of life diaries. Patients will return to clinic for a two week post-operative visit.\n\nPrior to surgery, the patients will undergo a physical examination by a physician who is blinded to the patient's surgical group assignments. Additionally, patients will fill out the SF-12 health survey, EHP-30 and activity assessment questionnaires, pain scale and daily pain medication / narcotic use at baseline.\n\nAt the 2 week postoperative visit, a routine physical exam will be performed, the daily pain medication diary will be retrieved and the questionnaires for surgical pain and activity assessment will be applied.\n\nAt 6 weeks and 6 months, the nurse or physician will repeat the questionnaires by email (using Redcap), mailed questionnaires or over the telephone (SF-12, EHP-30, pain scales, daily pain medication / narcotic use and activity assessment questionnaires). The physician or nurse will also collect all the intraoperative and inpatient data for this project as well as review the medical record for possible admissions and postoperative complications.\n\nAll data points and demographic information will be recorded in a secured, password protected database on the Gynresearch drive that will only be assessed by the collaborators on this IRB. Subjects will only be identified by their Cleveland Clinic medical record number. It is necessary to identify patients in this manner so that their clinical progress (e.g. postoperative complications, emergency room visits) can be located and recorded on the database."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women 18 years of age or greater who are to undergo laparoscopic treatment of presumed endometriosis, as determined clinically by the operating surgeon.\n\nExclusion Criteria:\n\n* suspected malignancy,\n* medical illness precluding laparoscopy,\n* inability to give informed consent,\n* morbid obesity (BMI \\> 44), or\n* need for concomitant bowel resection and/or ureteral reanastomosis.'}, 'identificationModule': {'nctId': 'NCT01556204', 'acronym': 'LAROSE', 'briefTitle': 'Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '12-173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Surgery', 'description': 'Robotic surgery using the da Vinci Surgical System', 'interventionNames': ['Procedure: Robotic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopy', 'description': 'Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.', 'interventionNames': ['Procedure: Laparoscopic Surgery']}], 'interventions': [{'name': 'Robotic surgery', 'type': 'PROCEDURE', 'description': 'The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).', 'armGroupLabels': ['Robotic Surgery']}, {'name': 'Laparoscopic Surgery', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopy'], 'description': 'The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).', 'armGroupLabels': ['Laparoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Tommaso Falcone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}