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Rectal CancerTaRoNCT04091620

Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision

A study testing Transanal Total Mesorectal Excision and Robotic Total Mesorectal Excision in people with Rectal Cancer, run by Chinese University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Laparoscopic total mesorectal excision (TME) for rectal cancer is technically challenging because of the confined space within the pelvis. The robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Transanal Total Mesorectal Excision and Robotic Total Mesorectal Excision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
1 Oct 2019to Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy
  • Those with clinically diagnosed cT1-3, N0-2, M0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography
  • Age of patients greater than or equal to 18 years
  • Those with American Society of Anesthesiologists (ASA) grading I-III,
  • Informed consent available

Who cannot join

  • Patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy)
  • Those with locally advanced T4 cancer requiring en bloc multivisceral resection
  • Those with very low rectal tumor requiring abdominoperineal resection
  • Those with synchronous colorectal tumors requiring multisegment resection
  • Those undergoing emergency surgery
  • Those with previous history of abdominal surgery precluding the robotic or laparoscopic approach;
Show all 9Show fewer
  • Those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous
  • Those with psychiatric disease
  • Those who are pregnant

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Prince of Wales Hospital, The Chinese University of Hong Kong

    Hong Kong

    Simon SM Ng, MD, (852) 3505 1495, simonng@surgery.cuhk.edu.hk

    Tony WC Mak, MD, (852) 3505 1495, tonymak@surgery.cuhk.edu.hk

    Recruiting

Other trials in China

About this study

Official title: Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision for Mid and Low Rectal Cancer: A Prospective Randomized Controlled Trial

Background: Laparoscopic total mesorectal excision (TME) for rectal cancer is technically challenging because of the confined space within the pelvis. The robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is expensive. Transanal total mesorectal excision (TaTME) is an emerging surgical approach that allows dissection of the most difficult part of the TME plane deep down in the pelvis using a less costly transanal platform. To date, no randomized controlled trial can be found in the literature comparing TaTME and robotic TME.

Objectives: To compare the pathologic outcomes, functional outcomes, and costs between TaTME and robotic TME for mid or low rectal cancer.

Read more

Design: Prospective, randomized, controlled, superiority trial.

Subjects: One hundred and eight consecutive patients who are clinically diagnosed with cT1-3, N0-2, M0 rectal cancer located within 12 cm of the anal verge who do not require abdominoperineal resection will be recruited.

Interventions: Patients will be randomly allocated to undergo either TaTME or robotic TME.

Outcome measures: Primary outcome: composite pathologic endpoint (complete TME, clear circumferential and distal resection margins). Secondary outcomes: conversion rate, postoperative recovery, morbidity, health-related quality of life, urosexual function, and costs.

Hypothesis: Results of the present study can provide evidence-based clarification of the efficacy and safety of TaTME for patients with mid and low rectal cancer. The results of this proposed project may have a significant impact on the future treatment strategy for mid and low rectal cancer.

Conditions
Rectal Cancer
Being tested
Transanal Total Mesorectal Excision, Robotic Total Mesorectal Excision
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transanal Total Mesorectal ExcisionProcedure or surgery

    As above

  • Robotic Total Mesorectal ExcisionProcedure or surgery

    As above

Study groups in NCT04091620
Study groupRoleWhat they receive
Transanal Total Mesorectal ExcisionExperimentalFor transanal total mesorectal excision, a two team approach will be adopted. One surgical team will be performing the abdominal phase dissection using standard laparoscopic approach, while the other will be simultaneously performing the transanal dissection and total mesorectal excision in a 'down-to-up' fashion using laparoscopic instruments.
Receives: Procedure: Transanal Total Mesorectal Excision
Robotic Total Mesorectal ExcisionActive comparatorFor robotic total mesorectal excision, a fully robotic approach will be adopted. Left-sided colonic mobilization, division of lymphovascular pedicle, and 'top-to-down' total mesorectal excision will be performed using the robotic platform.
Receives: Procedure: Robotic Total Mesorectal Excision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection

    Achieving a composite pathologic endpoint or a successful resection is defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) clear circumferential resection margin (>1 mm), and (3) clear distal resection margin (> 1mm).

    Measured: Up to 1 month

Secondary outcomes (14)
  1. Rate of conversion

    Conversion is defined as an abdominal incision larger than necessary for specimen retrieval for the abdominal phase of transanal total mesorectal excision (TME) and robotic TME; for the transanal phase of transanal TME conversion is defined as failure to complete a 'down-to-up' TME transanally, and the majority of the TME has to be completed using the abdominal approach.

    Measured: Up to 1 month

  2. Time to defecation

    Measured: Up to 1 month

  3. Time to resume full solid diet

    Measured: Up to 1 month

  4. Time to walk independently

    Measured: Up to 1 month

  5. Length of hospital stay

    Measured: Up to 1 month

  6. Pain scores on visual analog scale

    From 0 which implies no pain at all, to 100 which implies the worst pain imaginable, on the first 3 postoperative days.

    Measured: Up to 1 month

  7. Morbidity within 30 days

    Surgical complications are classified according to the Clavien-Dindo classification.

    Measured: Up to 1 month

  8. Urinary function at 3, 6, 9, and 12 months after surgery, measured by the International Prostate Symptom Score (IPSS)

    IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

    Measured: Up to 12 months

  9. Male sexual function at 3, 6, 9, and 12 months after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)

    IIEF-5 is an abridged five-item version of the 15-item International Index of Erectile Function (IIEF) which is used to diagnose the presence and severity of erectile dysfunction. This questionnaire consists of only five questions and each IIEF-5 item is scored on a five-point ordinal scale where lower values represent poorer sexual function. Thus, a response of 0 for a question is considered the least functional, whereas a response of 5 is considered the most functional. The possible scores for the IIEF-5 range from 1 to 25 (one question has scores of 1-5), and a score above 21 is considered as normal erectile function and at or below this cutoff, erectile dysfunction.

    Measured: Up to 12 months

  10. Anal continence at 3, 6, 9, 12 months after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)

    The Cleveland Clinic Incontinence Score or Wexner's Score is the most common score used to determine the severity of incontinence before and after surgery for anal incontinence. The scoring system takes into account the type and frequency of incontinence, and the extent to which it alters the patient's life. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that may range from 0 to 20. Higher scores indicate higher levels of incontinence.

    Measured: Up to 12 months

  11. Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 3, 6, 9, 12 months after surgery

    The Short Form 36 (SF-36) Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: Up to 12 months

  12. Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 3, 6, 9, 12 months after surgery

    EORTC QLQ-C30 is a generic questionnaire for assessment of quality of life (QoL) in cancer patients. It includes 30 items, 24 of which are combined to form a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and three symptom scales (fatigue, nausea/vomiting, and pain). The other six single items evaluate dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.

    Measured: Up to 12 months

  13. Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 3, 6, 9, 12 months after surgery

    EORTC QLQ-CR38 is a specific questionnaire module specifically designed for assessment of quality of life (QoL) in patients with colorectal cancer. It consists of 38 items covering symptoms and side effects related to different colorectal cancer treatment modalities. The module contains four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and eight symptom scales/items (micturition problems, chemotherapy side effects, gastrointestinal tract symptoms, male sexual problems, female sexual problems, defecation problems, stoma-related problems, and weight loss). All questionnaires responses and scores will be linearly transformed to a 0-100 scale. A higher score on the global QoL and functional scales represents a higher level of QoL and functioning, whereas a higher score on the symptom scales/items represents a higher degree of symptoms or dysfunction.

    Measured: Up to 12 months

  14. Direct/indirect medical costs and out-of-hospital economic costs

    Measured: Up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start1 Oct 2019
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091620
Sponsor's protocol ID
CREC 2019.072
Acronym
TaRo
Status last verified
Sep 2019
First submitted
14 Sep 2019
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transanal Total Mesorectal Excision and Robotic Total Mesorectal Excision in people with Rectal Cancer, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simon SM Ng, MD (+852-35051495, simonng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.

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