Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03683446
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2018-09-19
Brief Title:
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer
Sponsor:
Catherine H Davis MD
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer From 2005 to 2016 Using the ACS-NSQIP Database a Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2018-09
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:
NSQIPc
Brief Summary:
Retrospective cohort study used to analyze trends in minimally invasive versus open surgery in colorectal surgery over time in outcome in the laparoscopic robotic and open surgery groups in patients receiving colorectal resections Analysis will be performed using data collected through the American College of Surgeons ACS National Surgical Quality Improvement Project NSQIP database a national database with deidentified data entered by trained nurse data reviewers
Detailed Description:
Perioperative outcomes in patients undergoing laparoscopic compared to open surgery have been improving and adoption of these procedures has rapidly escalated Despite this minimally invasive surgery in rectal cancer is more controversial now than ever before While laparoscopy was initially limited to non-oncologic operations it has been shown to produce equivalent oncologic outcomes as open surgery and is now a preferred technique for colon cancer resection However laparoscopy is technically challenging in the deep pelvis and there is concern for adequate resection of rectal cancers
Multiple clinical trials are ongoing to assess long-term oncologic outcomes in patients with laparoscopically-resected rectal cancers ACOSOG ALaCaRT COLOR II COREAN1-4 yet current data examining perioperative outcomes in these patients is limited56 As there are conflicting conclusions between ongoing randomized control trials about the appropriateness of laparoscopic surgery for rectal cancers knowledge about perioperative outcomes and trends in these outcomes over time may give surgeons more information to make clinical decisions To address this gap the American College of Surgeons ACS National Surgical Quality Improvement Program NSQIP database was examined to determine the prevalence of laparoscopic surgery and 30-day outcomes over a ten-year period in patients undergoing open and laparoscopic surgery for rectal cancer
Using the ACS-NSQIP database from 2005-2016 resections for rectal cancer will be studied The proportion of laparoscopic versus open surgeries performed will be determined by year and 16 30-day outcomes will be studied in each group Outcomes include death cardiac arrest cerebrovascular accident myocardial infarction pulmonary embolism venous thromboembolism pneumonia prolonged ventilation superficial or deep incisional surgical site infection organ space infection renal insufficiency acute renal failure urinary tract infection length of hospital stay and operating room time Multiple logistic regression will be utilized to determine the association between laparoscopic and open technique as well as odds of outcome over time
Multiple clinical trials are ongoing to assess long-term oncologic outcomes in patients with laparoscopically-resected rectal cancers ACOSOG ALaCaRT COLOR II COREAN1-4 yet current data examining perioperative outcomes in these patients is limited56 As there are conflicting conclusions between ongoing randomized control trials about the appropriateness of laparoscopic surgery for rectal cancers knowledge about perioperative outcomes and trends in these outcomes over time may give surgeons more information to make clinical decisions To address this gap the American College of Surgeons ACS National Surgical Quality Improvement Program NSQIP database was examined to determine the prevalence of laparoscopic surgery and 30-day outcomes over a ten-year period in patients undergoing open and laparoscopic surgery for rectal cancer
Using the ACS-NSQIP database from 2005-2016 resections for rectal cancer will be studied The proportion of laparoscopic versus open surgeries performed will be determined by year and 16 30-day outcomes will be studied in each group Outcomes include death cardiac arrest cerebrovascular accident myocardial infarction pulmonary embolism venous thromboembolism pneumonia prolonged ventilation superficial or deep incisional surgical site infection organ space infection renal insufficiency acute renal failure urinary tract infection length of hospital stay and operating room time Multiple logistic regression will be utilized to determine the association between laparoscopic and open technique as well as odds of outcome over time
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?:
False
Is an FDA AA801 Violation?:
None