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

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

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

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Procedure: gasless single-port laparoscopic surgery; Procedure: conventional laparoscopic surgery

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University
      • Contact: Jijian Wang, MD,phD; Phone Number: 86-23-63693511; Email: wangjj1963@163.com
      • Contact: Jianbo Zhang, MD,phD; Phone Number: 86-23-63693510; Email: 172329491@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: gasless single-port laparoscopic surgery; radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.	Procedure: gasless single-port laparoscopic surgery; The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
SHAM_COMPARATOR: conventional laparoscopic surgery; radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.	Procedure: conventional laparoscopic surgery; The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Measure the operation time, which will be compared with comparator.	at 1 day
Postoperative pain	Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.	72 hours after operation
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Jijian Wang, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Yaxu Wang, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Yang Li, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Daihua Zhu, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Jianbo Zhang, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Haitao Gu, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Shiji Zhou, phD, The Second Affiliated Hospital of Chongqing Medical University; Principal Investigator: Zhiquan Xu, Bachelor, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: gasless single-port laparoscopic surgery;rectal carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 2017140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No