The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer
Condition: Rectal Cancer; Surgery
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): no-scar transanal total mesorectal excision(TME)
Intervention type(s): Procedure
Other intervention name(s): Pure NOTES transanal TME; TaTME; TAMIS TME; single-port transanal TME
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal cancer; no scar; NOTES; TaTME; feasibility; safety