Learning Curve of Robotic Pancreatoduodenectomy

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06094465

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A few reports were focused on the RPD learning curve for surgeons with extensive experience in LPD. Therefore, this study aimed to investigate the number of cases required for such surgeons to overcome the learning curve for RPD and to analyze the impact of different phases of the learning curve on perioperative outcomes.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy	Other: Different phase of the learning curve of RPD

Detailed Description

With the development of robotic surgery systems, their unique advantages over traditional laparoscopic surgery systems, such as a three-dimensional 10-fold magnified view, seven degrees of freedom for flexible wrist movements, tremor filtering, and good ergonomic design, have significantly improved the precision and quality of surgery. The literature has reported that, compared with the laparoscopic surgery system, the robotic surgery system can reduce intraoperative blood loss and the conversion rate to laparotomy, in addition to the dissection of more lymph nodes. Therefore, robotic surgery has become increasingly popular. As the economy develops and surgeons gain more experience in LPD, many are shifting their focus to robotic pancreatoduodenectomy after mastering laparoscopic techniques. There are a few reports on the RPD learning curve for surgeons with extensive experience in LPD. Therefore, this study aimed to investigate the number of cases required for such surgeons to overcome the learning curve for RPD and to analyze the impact of different phases of the learning curve on perioperative outcomes.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Learning Curve of Robotic Pancreatoduodenectomy for Surgeons With Extensive Laparoscopic Pancreatoduodenectomy Experience

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
learning phase According to the CUSUM curve, the phase before the peak of the curve is defined as the learning phase.	Other: Different phase of the learning curve of RPD Different phases of the learning curve of RPD (learning phase or proficiency phase)
proficiency phase According to the CUSUM curve, the phase after the peak of the curve is defined as the learning phase.	Other: Different phase of the learning curve of RPD Different phases of the learning curve of RPD (learning phase or proficiency phase)

Arm

Intervention/Treatment

learning phase

According to the CUSUM curve, the phase before the peak of the curve is defined as the learning phase.

Other: Different phase of the learning curve of RPD

Different phases of the learning curve of RPD (learning phase or proficiency phase)

proficiency phase

According to the CUSUM curve, the phase after the peak of the curve is defined as the learning phase.

Other: Different phase of the learning curve of RPD

Different phases of the learning curve of RPD (learning phase or proficiency phase)

Outcome Measures

Primary Outcome Measures

Intraoperative operation time [the data was recorded and collected at the end of the surgery]
Intraoperative operation time, defined as the duration from the skin incision to abdominal closure
Intraoperative blood loss [the data was recorded and collected at the end of the surgery]
Intraoperative blood loss
Conversion to laparotomy [The data was recorded and collected at the end of the surgery]
Conversion to laparotomy
Postoperative complications [up to 3 months after surgery]
Postoperative pancreatic fistula; hemorrhage, abdominal infection, reoperation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients who received robotic pancreaticoduodenectomy

Exclusion Criteria:

patients who did not receive robotic pancreaticoduodenectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Chair: Menghua Dai, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT06094465

Other Study ID Numbers:

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

robotic pancreaticoduodenctomy

learning curve

Study Results

No Results Posted as of Oct 23, 2023