NCT03318185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

September 20, 2017

Last Update Submit

January 10, 2018

Conditions

Laparoscopic Surgery

Keywords

gasless single-port laparoscopic surgery;rectal carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Operation time

    at 1 day

  • Postoperative pain

    72 hours after operation

  • Bowel function

    up to 1 week after operation

  • Number of the lymph node dissection

    at 1 week after operation

Study Arms (2)

gasless single-port laparoscopic surgery

EXPERIMENTAL

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

Procedure: gasless single-port laparoscopic surgery

conventional laparoscopic surgery

SHAM COMPARATOR

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

Procedure: conventional laparoscopic surgery

Interventions

gasless single-port laparoscopic surgeryPROCEDURE

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

gasless single-port laparoscopic surgery
conventional laparoscopic surgeryPROCEDURE

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

conventional laparoscopic surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neoadjuvant therapy;Surgical contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, China

RECRUITING

Study Officials

  • Jijian Wang, phD

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijian Wang, phD

CONTACT

02363693511wangjj1963@163.com

Jianbo Zhang, phD

CONTACT

02363693510172329491@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

October 23, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2019

Study Completion

September 1, 2020

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)