Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer

NCT ID: NCT03683446

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31795 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2017-12-30

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, 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Laparoscopic rectal surgery

Intervention Type: PROCEDURE

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.

Open rectal surgery

Intervention Type: PROCEDURE

Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.

Interventions

Laparoscopic rectal 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.

Intervention Type: PROCEDURE

Open rectal surgery

Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.

Intervention Type: PROCEDURE

Other Intervention Names

Open surgery

Eligibility Criteria

Inclusion Criteria

• Primary diagnosis of Rectal Cancer

Exclusion Criteria

• Emergency Surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catherine H. Davis, MD

OTHER

Sponsor Role: lead

Responsible Party

Catherine H. Davis, MD

Principal Investigator, Houston Methodist Hospital Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Catherine H Davis, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 26441180 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21414814 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

Pro00014677

Identifier Type: -

Identifier Source: org_study_id