Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02500992
Status:
UNKNOWN
Last Update Posted:
2015-07-17
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Microbacteriological swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peritoneal bacterial contamination', 'timeFrame': 'during surgery', 'description': 'microbacteriological swabs'}, {'measure': 'Contamination in the rectal stump after wash-out', 'timeFrame': 'during surgery'}], 'secondaryOutcomes': [{'measure': 'septic complications', 'timeFrame': 'within 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diverticular Disease']}, 'descriptionModule': {'briefSummary': 'Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.\n\nStill an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.\n\nIn this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Status post several episodes of diverticulitis\n* Status post contained diverticulitis\n\nExclusion Criteria:\n\n* not able to give informed consent\n* \\<18 years of age\n* pregnancy\n* emergency operation\n* acute diverticulitis'}, 'identificationModule': {'nctId': 'NCT02500992', 'briefTitle': 'Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hosptal, Baselland'}, 'officialTitle': 'Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease', 'orgStudyIdInfo': {'id': 'NoBakt transrectal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transrectal sigmoidectomy', 'description': 'Patients undergoing transrectal NOTES sigmoidectomy', 'interventionNames': ['Procedure: Transrectal sigmoidectomy']}, {'label': 'Laparoscopic-assisted sigmoidectomy', 'description': 'Patients undergoing laparoscopic-assisted sigmoidectomy'}], 'interventions': [{'name': 'Transrectal sigmoidectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Transrectal sigmoidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4101', 'city': 'Bruderholz', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Daniel C Steinemann, MD', 'role': 'CONTACT', 'email': 'daniel.steinemann@ksbl.ch'}, {'name': 'Sebastian Lamm, MD', 'role': 'CONTACT', 'email': 'sebastian.lamm@ksbl.ch'}, {'name': 'Sebastian Lamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel C Steinemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andreas Zerz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital Baselland Bruderholz', 'geoPoint': {'lat': 47.5296, 'lon': 7.59902}}], 'centralContacts': [{'name': 'Daniel C Steinemann, MD', 'role': 'CONTACT', 'email': 'daniel.steinemann@ksbl.ch', 'phone': '41 61 436 27 04'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hosptal, Baselland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Daniel Steinemann, MD', 'investigatorAffiliation': 'Cantonal Hosptal, Baselland'}}}}