Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma

Laparoscopic Surgery Clinical Trial

Official title:

Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03318185
• Other study ID #: 2017140
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2017
• Last updated: January 10, 2018
• Start date: November 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2018
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Jijian Wang, phD
• Phone: 02363693511
• Email: wangjj1963[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.

Description:

The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.

Exclusion Criteria:

• Neoadjuvant therapy;Surgical contraindication.

Related Conditions & MeSH terms

• Carcinoma
• Laparoscopic Surgery

Intervention

Procedure:
• gasless single-port laparoscopic surgery
The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
• conventional laparoscopic surgery
The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.

Locations

Country	Name	City	State
China	Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.	Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.
Primary	Immunologic function	Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers.	Change from baseline CD4/CD8 ratio 7 days after operation.
Secondary	Operation time	Measure the operation time, which will be compared with comparator.	at 1 day
Secondary	Postoperative pain	Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.	72 hours after operation
Secondary	Bowel function	Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus.	up to 1 week after operation
Secondary	Number of the lymph node dissection	Measure the number of the regional lymph node dissection after operation, which will be compared with comparator.	at 1 week after operation