Colorectal AdenocarcinomaNSQIPcNCT03683446
Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer
An observational study of Colorectal Adenocarcinoma and Colorectal Surgery, run by Catherine H. Davis, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma, Colorectal Surgery
- What is being tested?
- Laparoscopic rectal surgery and Open rectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 31,795 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 30 Dec 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18+ undergoing surgery for primary diagnosis of rectal cancer between 2005-2016 in the American College of Surgeons National Surgical Quality Improvement Program
Who may be able to join
- Primary diagnosis of Rectal Cancer
Who cannot join
- Emergency Surgery
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Adenocarcinoma, Colorectal Surgery
- Being tested
- Laparoscopic rectal surgery, Open rectal surgery
- Keywords
- Colorectal Cancer, Colorectal, Colorectal surgery, Surgical complications, Rectal, Rectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic rectal surgeryProcedure or surgery
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 surgeryProcedure or surgery
Also called Open surgery
Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic rectal surgery | |
| Open Rectal Surgery | Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum. Receives: Procedure: Open rectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
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
Measured: Post-procedure through day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jan 2005
- Primary completion30 Jan 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 31,795 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Catherine H. Davis, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine H. Davis, MD, The Methodist Hospital Research Institute
- Investigators
- Catherine H Davis, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683446
- Sponsor's protocol ID
- Pro00014677
- Acronym
- NSQIPc
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ACS-NSQIP database is available by researcher request to the American College of Surgeons. The investigators in this study do not have the authority to share this data independently.
Publications
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.
PubMed 26441179Stevenson 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.
PubMed 26441180Bonjer 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.
PubMed 26154803Jeong 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.
PubMed 24837215Greenblatt 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.
PubMed 21414814Jiang 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.
PubMed 26040854Vargas 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.
PubMed 26286013Pigazzi 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.
PubMed 16897284
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683446
- Acronym / sponsor ID
- NSQIPc / Pro00014677
- Conditions
- Colorectal Adenocarcinoma, Colorectal Surgery
- Keywords
- Colorectal Cancer, Colorectal, Colorectal surgery, Surgical complications, Rectal, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,795 participants (actual)
- Lead sponsor
- Catherine H. Davis, MDUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Rectal Surgery | – | Procedure: Laparoscopic rectal surgeryA 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. |
| Open Rectal Surgery | – | Procedure: Open rectal surgerySurgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18+ undergoing surgery for primary diagnosis of rectal cancer between 2005-2016 in the American College of Surgeons National Surgical Quality Improvement Program
Key inclusion criteria (1 listed)
- Primary diagnosis of Rectal Cancer
Key exclusion criteria (1 listed)
- Emergency Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic rectal surgeryMinimally 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. | Procedure or surgery | Laparoscopic Rectal Surgery |
| Open rectal surgeryAlso: Open surgerySurgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum. | Procedure or surgery | Open Rectal Surgery |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Background: PubMed 26441179Fleshman 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.
- Background: PubMed 26441180Stevenson 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.
- Background: PubMed 26154803Bonjer 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.
- Background: PubMed 24837215Jeong 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.
- Background: PubMed 21414814Greenblatt 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.
- Background: PubMed 26040854Jiang 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.
- Background: PubMed 26286013Vargas 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.
- Background: PubMed 16897284Pigazzi 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.
- Individual participant dataSharing planned: No. The ACS-NSQIP database is available by researcher request to the American College of Surgeons. The investigators in this study do not have the authority to share this data independently.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine H Davis, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma and Colorectal Surgery, run by Catherine H. Davis, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications (time frame: Post-procedure through day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683446, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.