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The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer

The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943694
Acronym
FSI-TaTME
Enrollment
32
Registered
2016-10-25
Start date
2016-12-31
Completion date
2018-12-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

TaTME, Complications, Instrument

Brief summary

Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer patients have been considerably improved. However, anatomical limitations in pelvic space hinder the further optimization of surgical treatment Thus, the natural orifice transluminal endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception and single port technique, has been prevailing both in West and East nations, with or without the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws in each instrument remains according to the feedbacks. This study is therefore designed to clinically evaluate the feasibility and safety of the new instruments specifically for TaTME (CS-Compact, GelPoint pathway).

Detailed description

Rectal cancer comprises the most in colorectal cancer around the world, among which surgery remains the optimal therapeutic intervention. The TME (Total Mesorectal Excision), proposed by Bill Heald, provides novel insights for the eradication of possible disseminated cancer cells and therefore reduces the recurrence and mortality rates. However, either laparoscopic or open TME surgery is limited by the pelvic space and further improvement. For the last decade, the emerging of the natural orifice transluminal endoscopic surgery (NOTES) offers an alternative pattern for rectal cancer surgery, among which, the TaTME (transanal total mesorectal excision) represents the most optimized surgery techniques. Derived from TME, NOTES and modified laparoscopic instruments, TaTME facilitates the dissection process of rectal cancer from caudal to cranial, from indirect to direct vision. TaTME allows for accurate confirmation of resected margin with proper transecting level, better dissection of mesorectum and protection of sphincter, a qualified end-to-end anastomosis and reduced need of endolinear stapler and possible leakage afterwards. However, various kinds of instruments and surgical procedures have been proposed to complete TaTME, all of which have been validated by preclinical and clinical trials in small size. Of note, this study is initiated to apply a suit of instruments specifically designed for TaTME ( GelPoint pathway CS-Compact) and clinically evaluate the feasibility and safety of the new instruments without comparison to other prevailing ones. The CS-Compact and GelPoint pathway has been confirmed both safe and feasible to operate in preclinical trials and clinical trials in western. This study strictly examines the corresponding issues in Chinese rectal cancer patients. The surgeons in our institute have successfully completed the training programs of TaTME in preclinical trials, in animal models and cadavers. Clinical skills and knowledge to safe operations are qualified.

Interventions

DEVICETaTME with CS-Compact (GelPoint pathway)

Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* rectal cancer patients, confirmed by the endoscopic biopsy; * curative rectal cancer in clinical stage with resectable lesion, the cTNM stage \<T3 stage, with comparable tumor size in low or medial rectum. * patients' general information, 18ys\<age\<75ys, no restriction in genders, BMI\< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification \<2 (Zubrod-ECOG-WHO) * patients or representatives have agreed and signed the informed consent documents.

Exclusion criteria

* have received neo-adjuvant chemotherapy or radiotherapy before operations; * previous surgery in pelvis * uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function. * suffer from other malignant diseases, i.e. gastric cancer, liver cancer. * pregnant, lactation stage. * metal disorders. * lacking qualified compliance.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with post-operative complicationspostoperative 30days (hospital-stay time course)Number of participants with post-operative complications (e.g. numbers of postoperative bleeding, leakage, infections)

Secondary

MeasureTime frameDescription
3-year disease free survival ratepostoperative 3years3-year disease free survival rate (the period after curative treatment without any detection of disease ), the detailed information of 3y-DFS will be obtained by period follow-up of patients by calls and outpatient checking.
3-year overall survival ratepostoperative 3years3-year overall survival rate (the survival period after curative treatment ), the detailed information of 3y-OS will be obtained by period follow-up of patients by calls and outpatient checking.

Contacts

Primary ContactJing Sun, Ph.D., M.D.
jingsun1982@sina.cn13524284622
Backup ContactJian-qing YAO, Ph.D.
JIANMARIA@HOTMAIL.COM13681815601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026