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

Phase 1

• Conditions: Postoperative Complications
• Interventions: Device: TaTME with CS-Compact (GelPoint pathway)

• Registration Number: NCT02943694
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-25
• Last Update Posted: 2016-10-25
• Study Start: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TaTME with CS-Compact (GelPoint Path)	TaTME with CS-Compact (GelPoint pathway)	Based on newly-designed devices tailored for transanal TME, CS-Compact, GelPoint and Octoport are employed for the clinical applications.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3-year overall survival rate	postoperative 3years	3-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.
3-year disease free survival rate	postoperative 3years	3-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.