Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 9:22 AM
Study NCT ID:
NCT06391060
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003075', 'term': 'Coitus'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gender Differences in Robotic Surgery for Rectal Cancer: a retrospective study', 'timeFrame': '15th of April 2024', 'description': 'gender-specific considerations in the surgical management and post-operative care of rectal cancer patients undergoing robotic surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Gender', 'Complication,Postoperative', 'Surgery-Complications']}, 'descriptionModule': {'briefSummary': 'Objective: To investigate gender-based differences in outcomes following robotic surgery for rectal cancer.\n\nMethods: A retrospective study was conducted on 155 patients (82 males, 73 females) who underwent robotic surgery for rectal cancer. Demographic, pre-operative, operative, and post-operative data were collected and analyzed.\n\nPre-operative study:\n\nAll patients underwent a standardized pre-operative work-up, which included a physical examination, comprehensive colonoscopy with biopsy, rigid rectoscopy, pelvic magnetic resonance imaging (MRI) scan, computed tomography (CT) of the thorax and abdomen, and measurement of carcinoembryonic antigen (CEA) levels. Tumor staging followed the TNM staging criteria (American Joint Committee on Cancer), with the T and N stages determined by the most advanced findings from any imaging modality\n\nData collected:\n\nRetrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery.\n\nPost-operative follow-up:\n\nPost-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Our institution, a government-affiliated university hospital, conducts various robotic procedures encompassing colorectal, hepato-biliary, gastro-esophageal, and retro-peritoneal surgeries. A comprehensive database of laparoscopic and robotic rectal surgeries has been established, with prospective data collection spanning from July 2021 to March 2024. Approval for the study was obtained from the institutional review board at Northern Jiangsu People's Hospital, and all operations were conducted utilizing the da Vinci Robotic Surgical System model Xi, manufactured by Intuitive Surgical, located in Sunnyvale, CA, USA.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA confirmed histological diagnosis of colorectal malignancy was a prerequisite for enrollment in this study. Additionally, obtaining informed consent from patients for surgical intervention was mandatory.\n\nExclusion Criteria:\n\nPatients with bleeding of the gastrointestinal tract, inflammatory bowel disease, synchronous tumors, benign conditions, and clinical T4 stage tumors unresponsive to neoadjuvant therapy were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06391060', 'briefTitle': 'Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study', 'orgStudyIdInfo': {'id': 'ali005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient characteristics group', 'description': 'Retrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery.', 'interventionNames': ['Procedure: Impact of Gender on Davinci rectal surgery']}, {'label': 'Post-operative group', 'description': 'Post-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis', 'interventionNames': ['Procedure: Impact of Gender on Davinci rectal surgery']}], 'interventions': [{'name': 'Impact of Gender on Davinci rectal surgery', 'type': 'PROCEDURE', 'otherNames': ['Davinci'], 'description': 'gender-specific considerations in the surgical management and post-operative care of rectal cancer patients undergoing robotic surgery', 'armGroupLabels': ['Patient characteristics group', 'Post-operative group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daorong Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daorong Wang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}