- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683446
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer (NSQIPc)
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer From 2005 to 2016 Using the ACS-NSQIP Database, a Retrospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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, COREAN)1-4; yet, current data examining perioperative outcomes in these patients is limited.5,6 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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary diagnosis of Rectal Cancer
Exclusion Criteria:
- Emergency Surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Laparoscopic Rectal Surgery
A minimally invasive surgery and specialized technique for performing surgery using smaller incisions (or ports) to enter into the abdomen or anus for a tubular instrument(trochar), and a special camera (laparoscope), which is passed through the trochars to visualize the colon.
For abdominal entry, at the beginning of the procedure, the abdomen is inflated with carbon dioxide gas to provide a working and viewing space for the surgeon.
For both, the laparoscope transmits images from the abdominal cavity or anus to high-resolution video monitors to allow the surgeon detailed images of the abdomen on the monitor.
|
Minimally invasive surgery and specialized technique for performing surgery using smaller incisions (or ports) to enter into the abdomen or anus for a tubular instrument(trochar), and a special camera (laparoscope), which is passed through the trochars to visualize the colon.
|
Open Rectal Surgery
Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.
|
Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications
Time Frame: Post-procedure through day 30
|
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
|
Post-procedure through day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine H Davis, MD, The Methodist Hospital Research Institute
Publications and helpful links
General Publications
- Jeong SY, Park JW, Nam BH, Kim S, Kang SB, Lim SB, Choi HS, Kim DW, Chang HJ, Kim DY, Jung KH, Kim TY, Kang GH, Chie EK, Kim SY, Sohn DK, Kim DH, Kim JS, Lee HS, Kim JH, Oh JH. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jun;15(7):767-74. doi: 10.1016/S1470-2045(14)70205-0. Epub 2014 May 15. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.
- Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J; ALaCaRT Investigators. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1356-63. doi: 10.1001/jama.2015.12009.
- Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529.
- Bonjer HJ, Deijen CL, Haglind E; COLOR II Study Group. A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer. N Engl J Med. 2015 Jul 9;373(2):194. doi: 10.1056/NEJMc1505367. No abstract available.
- Pigazzi A, Ellenhorn JD, Ballantyne GH, Paz IB. Robotic-assisted laparoscopic low anterior resection with total mesorectal excision for rectal cancer. Surg Endosc. 2006 Oct;20(10):1521-5. doi: 10.1007/s00464-005-0855-5. Epub 2006 Aug 1.
- Greenblatt DY, Rajamanickam V, Pugely AJ, Heise CP, Foley EF, Kennedy GD. Short-term outcomes after laparoscopic-assisted proctectomy for rectal cancer: results from the ACS NSQIP. J Am Coll Surg. 2011 May;212(5):844-54. doi: 10.1016/j.jamcollsurg.2011.01.005. Epub 2011 Mar 16.
- Jiang JB, Jiang K, Dai Y, Wang RX, Wu WZ, Wang JJ, Xie FB, Li XM. Laparoscopic Versus Open Surgery for Mid-Low Rectal Cancer: a Systematic Review and Meta-Analysis on Short- and Long-Term Outcomes. J Gastrointest Surg. 2015 Aug;19(8):1497-512. doi: 10.1007/s11605-015-2857-5. Epub 2015 Jun 4.
- Vargas GM, Sieloff EP, Parmar AD, Tamirisa NP, Mehta HB, Riall TS. Laparoscopy decreases complications for obese patients undergoing elective rectal surgery. Surg Endosc. 2016 May;30(5):1826-32. doi: 10.1007/s00464-015-4463-8. Epub 2015 Aug 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00014677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Surgery
-
Medical University of South CarolinaCompletedColorectal Surgery | Hepatobiliary SurgeryUnited States
-
Gulhane School of MedicineUniversity Hospital, Ghent; Szeged University; University Clinical Centre of... and other collaboratorsCompletedColorectal Disorders | Colorectal SurgeryTurkey
-
York Teaching Hospitals NHS Foundation TrustCompletedColorectal Surgery | Major Abdominal SurgeryUnited Kingdom
-
IHU StrasbourgRecruitingColorectal SurgeryFrance
-
Indiana UniversityCompletedColorectal SurgeryUnited States
-
Wake Forest University Health SciencesWithdrawnColorectal Surgery
-
University of Massachusetts, WorcesterCompleted
-
Helsinki University Central HospitalActive, not recruiting
-
Children's Hospital Medical Center, CincinnatiTerminated
-
York Teaching Hospitals NHS Foundation TrustTerminatedColorectal SurgeryUnited Kingdom
Clinical Trials on Laparoscopic rectal surgery
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalCompleted
-
University of California, IrvineUniversity of LeedsCompleted
-
Binh Dan HospitalCompleted
-
Japan Society of Laparoscopic Colorectal SurgeryUnknown
-
National Cancer Center, KoreaUnknownRectal CancerKorea, Republic of
-
The University of Hong KongUnknownAdenocarcinoma | Rectal CancerHong Kong
-
Fujian Medical UniversityZhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Peking Union... and other collaboratorsActive, not recruiting
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedColorectal CancerUnited States, Canada
-
Mansoura UniversityUniversity of Rome Tor VergataCompletedAnastomotic LeakageEgypt, Italy
-
University Hospital, GrenobleCompleted