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

Primary Purpose

Laparoscopic Surgery

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

gasless single-port laparoscopic surgery

conventional laparoscopic surgery

About this trial

This is an interventional treatment trial for Laparoscopic Surgery focused on measuring gasless single-port laparoscopic surgery;rectal carcinoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

gasless single-port laparoscopic surgery

conventional laparoscopic surgery

Arm Description

radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.

radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Operation time

Measure the operation time, which will be compared with comparator.

Postoperative pain

Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.

Bowel function

Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus.

Number of the lymph node dissection

Measure the number of the regional lymph node dissection after operation, which will be compared with comparator.

Full Information

NCT ID

NCT03318185

First Posted

September 20, 2017

Last Updated

January 10, 2018

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03318185

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

November 1, 2019 (Anticipated)

Study Completion Date

September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Surgery

Keywords

gasless single-port laparoscopic surgery;rectal carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gasless single-port laparoscopic surgery

Arm Type

Experimental

Arm Description

radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.

Arm Title

conventional laparoscopic surgery

Arm Type

Sham Comparator

Arm Description

radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.

Intervention Type

Procedure

Intervention Name(s)

gasless single-port laparoscopic surgery

Intervention Description

The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.

Intervention Type

Procedure

Intervention Name(s)

conventional laparoscopic surgery

Intervention Description

The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.

Primary Outcome Measure Information:

Title

Pulmonary function

Description

Time Frame

Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.

Title

Immunologic function

Description

Time Frame

Change from baseline CD4/CD8 ratio 7 days after operation.

Secondary Outcome Measure Information:

Title

Operation time

Description

Measure the operation time, which will be compared with comparator.

Time Frame

at 1 day

Title

Postoperative pain

Description

Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator.

Time Frame

72 hours after operation

Title

Bowel function

Description

Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus.

Time Frame

up to 1 week after operation

Title

Number of the lymph node dissection

Description

Measure the number of the regional lymph node dissection after operation, which will be compared with comparator.

Time Frame

at 1 week after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jijian Wang, phD

Phone

02363693511

wangjj1963@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jianbo Zhang, phD

Phone

02363693510

172329491@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jijian Wang, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yaxu Wang, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yang Li, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daihua Zhu, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jianbo Zhang, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Haitao Gu, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shiji Zhou, phD

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhiquan Xu, Bachelor

Organizational Affiliation

The Second Affiliated Hospital of Chongqing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastrointestinal Surgery Department of the Second Affiliated Hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jijian Wang, MD,phD

Phone

86-23-63693511

wangjj1963@163.com

First Name & Middle Initial & Last Name & Degree

Jianbo Zhang, MD,phD

Phone

86-23-63693510

172329491@qq.com

12. IPD Sharing Statement

Plan to Share IPD

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

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