Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer

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.

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Key information

Conditions

Colorectal Adenocarcinoma Colonic Diseases Colorectal Neoplasms Colorectal Surgery Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary diagnosis of Rectal Cancer

Exclusion criteria

Emergency Surgery

Treatment and study plan

Laparoscopic rectal surgery

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

Procedure

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

Other names: Open surgery

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Catherine H. Davis, MD

Other

Registry information

Official study 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

Acronym: NSQIPc

Important dates

Study start: 2005
Primary completion: 2017
Study completion: 2017
First posted: Sep 25, 2018
Registry last updated: Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed