The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer

December 16, 2016 updated by: Yanhong Deng, Sun Yat-sen University

A Pilot Study of the Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer Without Conventional Laparoscopic Assistance

During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach) has emerged and it is a concept that combines natural orifice transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative intent. The feasibility, safety and reproducibility of it were first demonstrated in swine survival experiments and subsequently in human cadaver series, and then it was successfully applied to human patients in few centers around the world, most of which were performed with assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases were more limited. In the initial stage, our group has successfully performed this no-scar transanal TME in a series of human cadavers with satisfactory outcome. Hence the investigators conduct this study, looking to see if this pure transanal NOTES investigational procedure is a safe and effective approach to radically remove rectal cancer of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function and life quality when gaining the best cosmetic effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic surgery(NOTES), the technique of single-port laparoscopic surgery and the principle of total mesorectal excision with curative intent for treating rectal cancer. Based on the platform of either transanal endoscopic microsurgery(TEM) or transanal minimally invasive surgery (TAMIS), it is an innovative way of retrograde TME dissection from bottom to up with or without laparoscopic assistance. It is supposed to facilitate distal rectal mobilization, thus achieving precise and sufficient distal margin and to reduced need for multiple stapler firings in transecting the rectum, consequently decreasing anastomotic leakage rates which is especially important for obese male patients with a narrow pelvis where exposure to the distal rectum from the abdominal approach can prove difficult. It could also protect neurovascular bundle with better visualization and exposure and has the advantage of better function and avoiding sacrificing sphincter. After a series of preclinical trail of animal and cadaver, it has been successfully applied to humans and successional reports have proved its feasibility and safety. However, the majority of published series is hybrid NOTES, which need the assistance of conventional laparoscopic surgery from above to bottom and abdominal incision, scar, pain and incision related complications such as wound infection, abscess, hernia and implanted incisional tumors cannot be necessary avoided. It is also worried that the cost will increased since two groups of surgical equipment are needed(the abdominal and perineal) and more surgical staff are required if the two team operate at the same time(two-team approach). Up to date, as far as we have known, the pure transanal TME NOTES without any laparoscopic assistance has also been successfully performed in human patients though the cases are rare. The investigators of our center have also successfully performed pure-NOTES rectal resection in human cadavers in the past few months, and are confident to move this forward to conduct this pilot study to evaluate the feasibility and safety of this surgery in rectal cancer patients.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Gastrointestinal Hospital, Sun Yatsen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy-proven adenocarcinoma of the rectum
  • No previous abdominal surgery, no distant metastasis or synchronous colon cancer
  • BMI≤ 35kg/m2
  • Clinical staging (T1 or T2 or T3) with N1-2M0
  • Patients of rectal adenocarcinoma with T3N0 or N (+) received preoperative concurrent chemoradiotherapy (CCRT) as neoadjuvant therapy
  • Rectal cancer located 4-12 cm from the anal verge
  • The diameter of primary tumor should <6cm
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • American Society of Anesthesiology (ASA) classⅠ to Ⅲ lesions
  • After the evaluation of Multi-disciplinary team (MDT)
  • Written informed consent

Exclusion Criteria:

  • T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs
  • Recurrent rectal cancer
  • Distant metastasis
  • Obstructing rectal cancer
  • Synchronous colon cancer
  • Pregnant or breast-feeding women
  • Fecal incontinence
  • History of prior colorectal cancer
  • History of inflammatory bowel disease
  • Other malignancies diagnosed within the previous year
  • Mental illness
  • Any evidence of active infection
  • History of bleeding diathesis or coagulopathy
  • Impaired renal or hepatic function that could not tolerate surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: no-scar transanal TME
no-scar transanal total mesorectal excision(TME) of rectal cancer
Procedure: no-scar transanal total mesorectal excision(TME)
Other Names:
  • Pure NOTES transanal TME
  • TaTME
  • TAMIS TME
  • single-port transanal TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite mesure of prioperative feasibility and safety
Time Frame: one-year
To evaluate the feasibility and safety by operative time, estimated blood loss, intraoperative complications, convert to Hybrid NOTES or open surgery, pathological outcome including Total Mesorectal Excision (TME) quality, the lymph nodes harvested, and specimen length, circumferential margin, etc. and postoperative complications graded according to Clavien-Dindo, reoperation rate, 30-day mortality, 30-day readmission
one-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite measure of life quality
Time Frame: 1-3 year
To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc
1-3 year
Composite mesure of postoperative outcome
Time Frame: one-year
To evaluate the postoperative outcome by length of hospital stay after operation, the time of first flatus, the time of recover to flow diet, postoperative pain by VAS, analgesic use ,etc
one-year
Composite mesure of oncological outcome
Time Frame: 1-3 year
3-year disease free survival (DFS), 3-year local recurrence rate, 3-year distal metastasis rate, 3-year overall survival (cancer related or non-cancer related)
1-3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Jianping Wang, MD, Sun Yatsen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIHSYSU08
  • D2014002 (Other Identifier: sysu 6th hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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