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

Not Applicable

• Conditions: Laparoscopic Surgery

• Registration Number: NCT03318185
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-23
• Study Start: 2017-11-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12
• Primary Completion: 2019-11-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary function	Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.	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.
Immunologic function	Change from baseline CD4/CD8 ratio 7 days after operation.	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.

Secondary Outcome Measures

Name	Time	Method
Number of the lymph node dissection	at 1 week after operation	Measure the number of the regional lymph node dissection after operation, which will be compared with comparator.
Operation time	at 1 day	Measure the operation time, which will be compared with comparator.
Postoperative pain	72 hours after operation	Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.
Bowel function	up to 1 week after operation	Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus.

Trial Locations

Locations (1)

Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China