Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-01 @ 4:12 PM
Study NCT ID:
NCT02841657
Status:
UNKNOWN
Last Update Posted:
2017-08-07
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Laparoscopy Versus 2D Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The postoperative course is evaluate in all patients undergone to colorectal laparoscopic surgery and classified according to the Dindo-Clavien scale at 30 days after surgery (Dindo-Clavien classification of surgical classification).'}], 'secondaryOutcomes': [{'measure': 'Oncological radicality', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'The R0/R1 rate is evaluate in patients undergone to 3 dimensional or 2 dimensional laparoscopic colorectal surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['3 Dimensional Laparoscopy', 'Visual work load', 'Nasa Task Load Index', 'Simulator Sickness Questionnaire'], 'conditions': ['Colorectal Cancer', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '27351662', 'type': 'RESULT', 'citation': 'Poudel S, Kurashima Y, Watanabe Y, Ebihara Y, Tamoto E, Murakami S, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Impact of 3D in the training of basic laparoscopic skills and its transferability to 2D environment: a prospective randomized controlled trial. Surg Endosc. 2017 Mar;31(3):1111-1118. doi: 10.1007/s00464-016-5074-8. Epub 2016 Jun 28.'}, {'pmid': '27143695', 'type': 'RESULT', 'citation': 'Sinha RY, Raje SR, Rao GA. Three-dimensional laparoscopy: Principles and practice. J Minim Access Surg. 2017 Jul-Sep;13(3):165-169. doi: 10.4103/0972-9941.181761.'}, {'pmid': '27059971', 'type': 'RESULT', 'citation': 'Shakir F, Jan H, Kent A. 3D straight-stick laparoscopy versus 3D robotics for task performance in novice surgeons: a randomised crossover trial. Surg Endosc. 2016 Dec;30(12):5380-5387. doi: 10.1007/s00464-016-4893-y. Epub 2016 Apr 8.'}, {'pmid': '26501704', 'type': 'RESULT', 'citation': 'Sakata S, Watson MO, Grove PM, Stevenson AR. The Conflicting Evidence of Three-dimensional Displays in Laparoscopy: A Review of Systems Old and New. Ann Surg. 2016 Feb;263(2):234-9. doi: 10.1097/SLA.0000000000001504.'}, {'pmid': '26107783', 'type': 'RESULT', 'citation': 'Usta TA, Gundogdu EC. The role of three-dimensional high-definition laparoscopic surgery for gynaecology. Curr Opin Obstet Gynecol. 2015 Aug;27(4):297-301. doi: 10.1097/GCO.0000000000000189.'}, {'pmid': '25772250', 'type': 'RESULT', 'citation': 'Ozsoy M, Kallidonis P, Kyriazis I, Panagopoulos V, Vasilas M, Sakellaropoulos GC, Liatsikos E. Novice surgeons: do they benefit from 3D laparoscopy? Lasers Med Sci. 2015 May;30(4):1325-33. doi: 10.1007/s10103-015-1739-0. Epub 2015 Mar 15.'}, {'pmid': '25560749', 'type': 'RESULT', 'citation': "Ashraf A, Collins D, Whelan M, O'Sullivan R, Balfe P. Three-dimensional (3D) simulation versus two-dimensional (2D) enhances surgical skills acquisition in standardised laparoscopic tasks: a before and after study. Int J Surg. 2015 Feb;14:12-6. doi: 10.1016/j.ijsu.2014.12.020. Epub 2015 Jan 2."}, {'pmid': '25461685', 'type': 'RESULT', 'citation': "Ko JK, Li RH, Cheung VY. Two-dimensional versus three-dimensional laparoscopy: evaluation of physicians' performance and preference using a pelvic trainer. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):421-7. doi: 10.1016/j.jmig.2014.11.007. Epub 2014 Nov 21."}, {'pmid': '25131843', 'type': 'RESULT', 'citation': 'Smith R, Schwab K, Day A, Rockall T, Ballard K, Bailey M, Jourdan I. Effect of passive polarizing three-dimensional displays on surgical performance for experienced laparoscopic surgeons. Br J Surg. 2014 Oct;101(11):1453-9. doi: 10.1002/bjs.9601. Epub 2014 Aug 18.'}, {'pmid': '25002241', 'type': 'RESULT', 'citation': 'Alaraimi B, El Bakbak W, Sarker S, Makkiyah S, Al-Marzouq A, Goriparthi R, Bouhelal A, Quan V, Patel B. A randomized prospective study comparing acquisition of laparoscopic skills in three-dimensional (3D) vs. two-dimensional (2D) laparoscopy. World J Surg. 2014 Nov;38(11):2746-52. doi: 10.1007/s00268-014-2674-0.'}, {'pmid': '24220007', 'type': 'RESULT', 'citation': 'Marcus HJ, Hughes-Hallett A, Cundy TP, Di Marco A, Pratt P, Nandi D, Darzi A, Yang GZ. Comparative effectiveness of 3-dimensional vs 2-dimensional and high-definition vs standard-definition neuroendoscopy: a preclinical randomized crossover study. Neurosurgery. 2014 Apr;74(4):375-80; discussion 380-1. doi: 10.1227/NEU.0000000000000249.'}]}, 'descriptionModule': {'briefSummary': '* To compare surgical and oncological outcomes in patients underwent to colorectal resection with 3D vs 2D laparoscopic technique.\n* To evaluate the visual overload in surgeons using 3D laparoscopic technique.', 'detailedDescription': "3 Dimensional (3D) Camera system is a new technique introduced into laparoscopic surgery field, adding the depth perception. Even if in the first 2000' the old 3D camera had negative results in terms of quality of images, thanks to technological progress the new 3D systems have reached high quality.\n\nThis new technology has been widely tested in pelvic trainer, not yet in live surgery. Moreover effects on surgeons visual work load are unknown.\n\nAim of the present study is to evaluate the potential superiority of 3D laparoscopic technique on 2D one in terms on postoperative complications and oncological radicality (in case of neoplastic disease).\n\nSecondary aim is to study the possible major visual stress on surgeons brain caused by 3D camera rather than 2D videos.\n\nENROLLMENT All patients affected by neoplastic or inflammatory colorectal disease are enrolled in the study.\n\nPreoperative, intraoperative e postoperative data are collected dividing all the patients according the camera system used during the operation: 2D group vs 3D group.\n\nPreoperative data: sex, age, date of birth, id, date of admission, past medical history Intraoperative data: date of surgery, pathology, site of pathology, type of surgery and duration, intraoperative blood loss, other intraoperative problems, loop ileostomy, colostomy, drain positioning, intensive care unit admission Postoperative data (at 30th postoperative day): complications according to Dindo-Clavien scale (Dindo-Clavien classification of surgical complications), type of complications, transfusion, reoperation, other treatments, histology specimen report.\n\nAt the end of every operation, the 1st surgeon has to fill in the NASA (The National Aeronautics and Space Administration) task load index and the Simulator Sickness questionnaire.\n\nNumber of participants: 350 Years necessary: 2"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients affected by neoplastic and inflammatory disease of colorectal tract can be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colorectal cancer with or without preoperative radio e chemiotherapy\n* inflammatory bowel disease affected colon and rectum that need surgery\n\nExclusion Criteria:\n\n* patients under 18 years'}, 'identificationModule': {'nctId': 'NCT02841657', 'acronym': 'Lap3D', 'briefTitle': '3D Laparoscopy Versus 2D Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': '3D vs 2D Colorectal Resections and Valuation of Visual Load of Surgeons', 'orgStudyIdInfo': {'id': '3Dvs2D'}}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Inama, MD, PhDs', 'role': 'CONTACT', 'email': 'inama.marco@gmail.com'}], 'facility': 'Hospital "Dott. Pederzoli"', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}], 'centralContacts': [{'name': 'Marco Inama, MD PhDs', 'role': 'CONTACT', 'email': 'inama.marco@gmail.com', 'phone': '+39 0456449319'}, {'name': 'Gianluigi Moretto, MD', 'role': 'CONTACT', 'email': 'g_moretto@libero.it', 'phone': '+39 0456449319'}], 'overallOfficials': [{'name': 'Marco Inama, MD PhDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital "Dott. Pederzoli"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon', 'investigatorFullName': 'Marco Inama', 'investigatorAffiliation': 'Casa di Cura Dott. Pederzoli'}}}}