Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391060
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Gender Differences in Robotic Surgery for Rectal Cancer a Retrospective Study
Sponsor:
Daorong Wang
Organization:
Northern Jiangsu Peoples Hospital
Study Overview
Official Title:
Gender Differences in Robotic Surgery for Rectal Cancer a Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To investigate gender-based differences in outcomes following robotic surgery for rectal cancer
Methods 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
Pre-operative study
All 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
Data collected
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 eg 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
Post-operative follow-up
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
Methods 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
Pre-operative study
All 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
Data collected
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 eg 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
Post-operative follow-up
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None