NCT07034495

Brief Summary

  1. 1.This study looks at whether newer surgical tools-like the da Vinci robotic system-can help patients recover better after major abdominal surgeries. It compares three surgery methods: traditional open surgery, standard laparoscopic (minimally invasive) surgery, and robotic surgery.
  2. 2.The research focused on four common operations: Stomach surgery (gastrectomy), Pancreas surgery (pancreatectomy), Liver surgery (hepatectomy) and andWhipple procedure
  3. 3.Researchers looked at medical records from 486 patients over five years. They compared how long each surgery took, how much blood was lost, and how many days patients stayed in the hospital.
  4. 4.The study wanted to see if robotic and laparoscopic surgeries help patients by making the surgery faster, safer, and with a quicker recovery.
  5. 5.The benefits depended on the type of surgery. In many cases, robotic and laparoscopic surgery led to shorter hospital stays, less bleeding, or faster surgeries. These results suggest that using newer technology can help make surgeries safer and recovery easier for patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4.3 years

First QC Date

June 1, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

Whipplehepatectomypancreatectomygastrectomy robotic surgerda Vinci Xi

Outcome Measures

Primary Outcomes (2)

  • operative time

    The duration of the operation

    From entry into the operating room for anesthesia induction to completion of skin closure at the end of surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours

  • bleeding

    The amount of intraoperative bleeding

    From initiation of surgery (skin incision) to completion of wound closure during surgery (Day 1, intraoperative period), assessed over an estimated duration of up to 10 hours.

Secondary Outcomes (1)

  • hospital stay

    From the date of surgery to the date of hospital discharge, assessed up to 55 days postoperatively

Study Arms (1)

three surgical methods in Laparotomy, Laparoscope, and da Vinci

no intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A population that needs robotic surgery for gastrectomy, liver resection, or pancreatectomy

You may qualify if:

  • Adult patients (age ≥ 18 years)
  • Underwent one of the following surgeries: gastrectomy, liver resection, or pancreatectomy
  • Received surgery at Chung Shan Medical University Hospital between July 2015 and September 2019
  • Surgery performed by the general surgery team with experience in open, laparoscopic, and robotic (da Vinci) surgery
  • Surgical method included one of the following: open surgery (laparotomy), laparoscopic surgery, or robotic (da Vinci) surgery

You may not qualify if:

  • Patients who underwent surgeries outside the specified types (i.e., not gastrectomy, liver resection, or pancreatectomy)
  • Patients with incomplete or missing perioperative data (e.g., operative time, blood loss, or hospital stay)
  • Patients who underwent combined or staged surgical procedures unrelated to the HPB domain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Stomach NeoplasmsPancreatic NeoplasmsLiver NeoplasmsCholangiocarcinomaPancreatitis, ChronicPancreatic Cyst

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCysts

Study Officials

  • Cheng-Ming Peng, MD, Ph.D.

    Department of Surgery, da Vinci Minimally Invasive Surgery Center, Chung Shan Medical University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 24, 2025

Study Start

July 1, 2015

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict the disclosure of patient-level data, even in de-identified form. Additionally, there is currently no plan or infrastructure in place for secure data sharing in accordance with applicable ethical and legal standards.

Locations