Clinical trial NCT03318185: Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
Official title: Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: gasless single-port laparoscopic surgery;rectal carcinoma
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary function
timeFrame: Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.
measure: Immunologic function
timeFrame: Change from baseline CD4/CD8 ratio 7 days after operation.
Secondary outcomes:
measure: Operation time
timeFrame: at 1 day
measure: Postoperative pain
timeFrame: 72 hours after operation
measure: Bowel function
timeFrame: up to 1 week after operation
measure: Number of the lymph node dissection
timeFrame: at 1 week after operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Jijian Wang, phD
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Yaxu Wang, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Yang Li, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Daihua Zhu, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Jianbo Zhang, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Haitao Gu, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Shiji Zhou, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Zhiquan Xu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: