Learning Curve of Robotic Pancreatoduodenectomy

October 19, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Department of General Surgery, Peking Union Medical College Hospital (PUMCH), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From April 2020 to October 2022, consecutive patients with RPD performed for benign or malignant lesions at Peking Union Medical College Hospital

Description

Inclusion Criteria:

patients who received robotic pancreaticoduodenectomy

Exclusion Criteria:

patients who did not receive robotic pancreaticoduodenectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative operation time
Time Frame: 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
the data was recorded and collected at the end of the surgery
Intraoperative blood loss
Time Frame: the data was recorded and collected at the end of the surgery
Intraoperative blood loss
the data was recorded and collected at the end of the surgery
Conversion to laparotomy
Time Frame: The data was recorded and collected at the end of the surgery
Conversion to laparotomy
The data was recorded and collected at the end of the surgery
Postoperative complications
Time Frame: up to 3 months after surgery
Postoperative pancreatic fistula; hemorrhage, abdominal infection, reoperation
up to 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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