Right colectomy
ProcedureRobotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
NCT Number: NCT03019016
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.
The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.
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Notify Me18 year and older
All sexes
Observational
This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.
It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
Time frame: Intraoperative through 30-days follow-up
Number of complications observed intraoperatively through 30-days
Time frame: Postoperative through 6 month follow-up
Number of complications observed postoperatively through 6 month
Intuitive Surgical
Industry
A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
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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.
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