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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03911167
Other study ID # XJTU1AF2019LSK-009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date July 1, 2018

Study information

Verified date January 2019
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;

- blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;

- without distant metastasis such as liver, lung, bone, and abdominal cavity.

Exclusion Criteria:

- there is distant organ transfer or extensive abdominal metastasis;

- emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;

- combined with other primary malignant tumors;

- other colonectomy and combined with other organ resection;

- patients with severe basic diseases unable to tolerate surgery;

- pregnant and lactating women;

- patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;

- those who underwent palliative surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
open, laparoscopic, and robotic
Radical resection of rectal cancer in robotic, laparoscopic, and open approach

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complication rate,% 2 weeks
Secondary Urine tube time,days; 2 weeks
Secondary operation time,minutes; 2 weeks
Secondary intraoperative bleeding,ml; 2 weeks
Secondary number of lymph node detection, 2 weeks
Secondary exhaust time,days; 2 weeks
Secondary intake time, days; 2 weeks
Secondary postoperative hospital stay,days; 2 weeks
Secondary hospitalization expenses,yuan 2 weeks
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