The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer
Primary Purpose
Rectal Cancer, Surgery
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
no-scar transanal total mesorectal excision(TME)
Sponsored by
![Sun Yat-sen University](https://trials-media.s3.amazonaws.com/orgs/sun-yat-sen-university.jpeg)
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, no scar, NOTES, TaTME, feasibility, safety
Eligibility Criteria
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
Sites / Locations
- Gastrointestinal Hospital, Sun Yatsen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
no-scar transanal TME
Arm Description
no-scar transanal total mesorectal excision(TME) of rectal cancer
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
composite measure of life quality
To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc
Composite mesure of postoperative outcome
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
Composite mesure of oncological outcome
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)
Full Information
NCT ID
NCT02236884
First Posted
September 4, 2014
Last Updated
December 16, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02236884
Brief Title
The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer
Official Title
A Pilot Study of the Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer Without Conventional Laparoscopic Assistance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Surgery
Keywords
rectal cancer, no scar, NOTES, TaTME, feasibility, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no-scar transanal TME
Arm Type
Experimental
Arm Description
no-scar transanal total mesorectal excision(TME) of rectal cancer
Intervention Type
Procedure
Intervention Name(s)
no-scar transanal total mesorectal excision(TME)
Other Intervention Name(s)
Pure NOTES transanal TME, TaTME, TAMIS TME, single-port transanal TME
Primary Outcome Measure Information:
Title
Composite mesure of prioperative feasibility and safety
Description
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
Time Frame
one-year
Secondary Outcome Measure Information:
Title
composite measure of life quality
Description
To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc
Time Frame
1-3 year
Title
Composite mesure of postoperative outcome
Description
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
Time Frame
one-year
Title
Composite mesure of oncological outcome
Description
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)
Time Frame
1-3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Wang, MD
Organizational Affiliation
Sun Yatsen University
Official's Role
Study Director
Facility Information:
Facility Name
Gastrointestinal Hospital, Sun Yatsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26220109
Citation
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.
Results Reference
background
PubMed Identifier
26310534
Citation
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.
Results Reference
result
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The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer
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