Clinical trial NCT03019016: Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
Official title: A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasms
Crohn Disease
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age ≥ 18 years Patients with benign or malignant right colon disease Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with benign or malignant right colon disease
* Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon

Exclusion Criteria:

* Patients with perforated, obstructing or locally invasive neoplasm (T4b)
* Emergency procedures
* Patients undergoing right colectomy as a secondary procedure
* Patients undergoing radiation therapy for malignant neoplasia before and after procedure

Primary outcomes:
measure: Chart review on PeriOperative Information
timeFrame: Intraoperative through 30-days follow-up
Secondary outcomes:
measure: Chart review on Postoperative Information
timeFrame: Postoperative through 6 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
name: Shilpa Mehendale
role: STUDY_DIRECTOR
References: