An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911167
• Other study ID #: XJTU1AF2019LSK-009
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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