- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03019016
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Robotic RC (IA)
Benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
Robotic RC (EA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
Laparoscopic RC (IA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
Laparoscopic RC (EA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Chart review on PeriOperative Information
Tidsram: Intraoperative through 30-days follow-up
|
Number of complications observed intraoperatively through 30-days
|
Intraoperative through 30-days follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Chart review on Postoperative Information
Tidsram: Postoperative through 6 month follow-up
|
Number of complications observed postoperatively through 6 month
|
Postoperative through 6 month follow-up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Shilpa Mehendale, Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Gastroenterit
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Kolorektala neoplasmer
- Inflammatoriska tarmsjukdomar
- Crohns sjukdom
- Kolonneoplasmer
Andra studie-ID-nummer
- ISI-dVRC-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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