NCT03700593

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.

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 all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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

October 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

October 2, 2018

Last Update Submit

February 18, 2020

Conditions

Colon CancerColon PolypRectal CancerDiverticulitisProlapse, RectalRectal PolypInflammatory Bowel Diseases

Keywords

Single port robotic surgeryMinimally invasive colectomySingle port robotic colectomySingle port robotic TEM

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the SP robot

    Calculating the percentage of cases successfully performed using the SP robot, without conversion.

    30 days

  • Rate of postoperative complications and mortality of the SP robot

    Measuring the post-operative morbidity and mortality will be used to evaluate the safety of the SP robot.

    30 days

Secondary Outcomes (4)

  • Assessment of patients quality of life using validated questionnaires.

    1 year

  • Assessment of patients' satisfaction with their surgical scars using validated questionnaires.

    1 year

  • Assessment of patient's quality of recovery

    1 year

  • Assessment of patients' postoperative body image satisfaction

    1 year

Study Arms (1)

Single Port Robotic Colorectal Surgery Patients

All patients who undergo a single port robot colorectal surgery.

Device: Single Port Robotic Colorectal Surgery

Interventions

Single Port Robotic Colorectal SurgeryDEVICE

Single Port Robotic Colorectal Surgery

Single Port Robotic Colorectal Surgery Patients

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a colorectal pathology requiring a minimally invasive colorectal procedure.

You may qualify if:

  • All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the study.

You may not qualify if:

  • emergency surgery
  • inability to offer informed consent
  • pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lankenau Medical Center, Marks Colorectal Surgical Associates

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (2)

  • Marks JH, Agarwal S, Kunkel E, Schoonyoung H, Salem JF. Video Demonstration of an Initial Single-Port Robotic Transanal Total Mesorectal Excision. Dis Colon Rectum. 2021 Aug 1;64(8):e472-e473. doi: 10.1097/DCR.0000000000002139. No abstract available.

    PMID: 34001710DERIVED

  • Marks JH, Kunkel E, Salem JF, Martin CT, Anderson B, Agarwal S. First Clinical Experience With Single-Port Robotic Transanal Minimally Invasive Surgery: Phase II Trial of the Initial 26 Cases. Dis Colon Rectum. 2021 Aug 1;64(8):1003-1013. doi: 10.1097/DCR.0000000000001999.

    PMID: 34001709DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsColonic PolypsRectal NeoplasmsDiverticulitisRectal ProlapseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRectal DiseasesDiverticular DiseasesGastroenteritisPelvic Organ ProlapseProlapse

Study Officials

  • John H Marks, MD

    Main Line Health System / Lankenau Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Colorectal Surgery

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 9, 2018

Study Start

October 15, 2018

Primary Completion

October 1, 2020

Study Completion

December 31, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)