NCT03597126

Brief Summary

This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 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

April 23, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

April 23, 2018

Last Update Submit

November 28, 2021

Conditions

Rectal Cancer

Keywords

RoboticIntersphincteric Resectionrectal cancerpelvic autonomic nerve anal function

Outcome Measures

Primary Outcomes (4)

  • Change in urinary function

    The days of indwelling catheter after operation The overall efficiency of urination function

    6 months

  • Change in International Index of Erectile Function [IIEF] score

    Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)

    18 months

  • Change in FIQL scores

    Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered

    18 months

  • Change in Female Sexual Function Index [FSFI]

    Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.

    18 months

Study Arms (2)

robot-assisted ISR

ACTIVE COMPARATOR

Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic

Device: Robot-assisted surgery

laparoscopic ISR

ACTIVE COMPARATOR

Patients with low rectal cancer undergo laparosocopic intersphincteric resection

Device: Laparoscopic surgery

Interventions

Robot-assisted surgeryDEVICE

robot-assisted intersphincteric resection for low location rectal cancer(T=1\&2)

robot-assisted ISR
Laparoscopic surgeryDEVICE

laparoscopic intersphincteric resection for low location rectal cancer(T=1\&2)

laparoscopic ISR

Eligibility Criteria

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

You may qualify if:

  • years \< age \< 80 years
  • Matching the diagnostic criteria;
  • tumor located 3 cm from anal verge
  • Clinically diagnosed cT1-3N0-2 M0 lesions
  • Tumor size of 4 cm or less
  • ASA 1-3 scores;
  • ECOG score is 0-1;
  • Adequate preoperative sphincter function

You may not qualify if:

  • Requiring a Mile's procedure
  • Fecal incontinence;
  • Previous abdominal surgery
  • Severe mental disease.
  • Intolerance of surgery for severe comorbidities
  • Emergency operation due to complication
  • Pregnant woman or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Robotic Surgical ProceduresLaparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Central Study Contacts

Tang Bo, M.D

CONTACT

+86 13883902288yupeiwu1961@aliyun.com

Li Chuan, M.D

CONTACT

+86-18323479228lee_tran@126.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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2018

First Posted

July 24, 2018

Study Start

December 1, 2018

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

CN(1)