NCT06397053

Brief Summary

Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. In RS, a surgeon employed the Da Vinci Xi surgical system featuring a five-port setup, while five physicians conducted LS with a similarly configured five-port approach. Both the RS and LS doctors are experienced. The surgeries were conducted according to standard procedures, and the RS group utilized totally robotic rectal resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

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

December 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

3.9 years

First QC Date

April 29, 2024

Last Update Submit

April 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • early postoperative problems

    early postoperative problems

    2019-2023

Study Arms (2)

laparoscopic surgery with visceral obesity

Procedure: robotic surgery

robotic surgery with visceral obesity

Procedure: robotic surgery

Interventions

robotic surgery

laparoscopic surgery with visceral obesityrobotic surgery with visceral obesity

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective investigation included participants who experienced anterior rectal resection using robotic or laparoscopic techniques at the General Surgery Department of Northern Jiangsu People's Hospital between December 2019 and October 2023.

You may qualify if:

  • (1) confirmed pathology of mid-to-low rectal cancer (within 10 centimeters from the anal margin); (2) availability of comprehensive pathological and computed tomography (CT) data; (3) presence of a diagnosis indicating visceral obesity.

You may not qualify if:

  • Multiple tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Obesity, AbdominalRectal Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

December 1, 2019

Primary Completion

October 30, 2023

Study Completion

January 29, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations