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NCT06396975 Clinical Trial

Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06396975
Other study ID # Northjiangsu020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date April 29, 2024

Study information
Verified date April 2024
Source Northern Jiangsu People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have different body mass indexes (BMIs). This study was done to organize the clinical data we had at our hospital so we could compare the perioperative effectiveness of two minimally invasive approaches for people with different BMIs.

Recruitment information / eligibility
Status Completed
Enrollment 1413
Est. completion date April 29, 2024
Est. primary completion date April 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: The inclusion decision was made based on the following criteria: the results of the preoperative evaluation revealed the existence of adenocarcinoma in the middle to lower rectum (less than 10 centimeters distant from the anal edge); received a drastic operation that might have been laparoscopic or robotic and was based on the principle of TME; distant metastases that are non-conformist or heteroclinic, and there are no additional malignant tumors present at the same time as the operation. Exclusion Criteria: a high tumor location that was more than 10 centimeters away from the anal margin; surgery was unsuccessful in completing anal preservation due to invasion of the external anal sphincter; cancerous obstruction or perforation; severe cardiopulmonary dysfunction classified as stage IV according to the ASA score; and poor preoperative anal function; any resection that is performed in combination, rather than being a R0 resection.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• robotic surgery
robotic surgery

Locations
Country Name City State
China Northern Jiangsu People's Hospital Yangzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Daorong Wang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oncological outcomes Oncological outcomes 2019-2023
Primary the frequency of complications the frequency of complications 2019-2023
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