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

NCT02236884 | Completed Phase 1 DMC

• 2 other identifiers: GIHSYSU08D2014002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer; Surgery

Keywords

rectal cancer; no scar; NOTES; TaTME; feasibility; safety

Outcome Measures

Primary Outcomes (1)

• Composite mesure of prioperative feasibility and safety

  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 Outcomes (3)

• composite measure of life quality

  1-3 year

• Composite mesure of postoperative outcome

  one-year

• Composite mesure of oncological outcome

  1-3 year

Study Arms (1)

no-scar transanal TME

EXPERIMENTAL

no-scar transanal total mesorectal excision(TME) of rectal cancer

Procedure: no-scar transanal total mesorectal excision(TME)

Interventions

no-scar transanal total mesorectal excision(TME) PROCEDURE

Also known as: Pure NOTES transanal TME, TaTME, TAMIS TME, single-port transanal TME

no-scar transanal TME

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Gastrointestinal Hospital, Sun Yatsen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (2)

• Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.

  PMID: 26220109 BACKGROUND

• Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.

  PMID: 26310534 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jianping Wang, MD

  Sun Yatsen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 11, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2014-09

Locations

CN (1)