NCT02673177

Brief Summary

This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

January 27, 2016

Last Update Submit

February 2, 2016

Conditions

Rectal Neoplasms

Keywords

robot-assisted total mesorectal excision(RTME)laparoscopic total mesorectal excision(LTME)urinary functionsexual functionsphincter- preservationlow rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of sexual and urinary dysfunction

    One years after surgery

Secondary Outcomes (2)

  • disease-free survival(DFS )

    3 years disease-free survival

  • Anus preservation rate

    One years after surgery

Study Arms (2)

Robot-assisted total mesorectal excision

EXPERIMENTAL

Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually.

Procedure: robot-assisted total mesorectal excision

Laparoscopic total mesorectal excision

ACTIVE COMPARATOR

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.

Procedure: laparoscopic total mesorectal excision

Interventions

robot-assisted total mesorectal excisionPROCEDURE

The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.

Robot-assisted total mesorectal excision
laparoscopic total mesorectal excisionPROCEDURE

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

Laparoscopic total mesorectal excision

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
  • \. Matching the diagnostic criteria;
  • \. Aged 18-70 years old;
  • \. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
  • \. Preoperative ASA 3 scores;
  • \. There was no history of malignancy, no other malignant tumors by preoperative examination;
  • \. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
  • \. The informed consent form was signed by the patient himself(herself)or his principal agent;
  • \. In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.

You may not qualify if:

  • \. Age less than 18 years old or more than 70 years old;
  • \. Previous psychiatric patients or patients refused to sign the informed consent;
  • \. Attending other related clinical studies on surgical treatment of rectal cancer;
  • \. The patient has a history of malignant tumor, or a combination of other malignant tumors;
  • \. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
  • \. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
  • \. ASA \>3;
  • \. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
  • \. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
  • \. Those who have urination sexual dysfunction preoperatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 3, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share