Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer

Rectal Cancer Clinical Trial

— MansTaTME  

Official title:

(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242187
• Other study ID #: MansTaTME/17.04.84
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 1, 2017
• Last updated: August 3, 2017
• Start date: May 25, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2017
• Source: Mansoura University
• Contact: Mohammad Z Metwally, Ass.Lecturer
• Phone: 00201068683363
• Email: mohammadzuhdy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the surgical, oncological and functional outcome of either the laparoscopic or trans-anal TME in management of mid and low rectal cancer.

Description:

Colorectal cancer (CRC) is considered the third most common type of cancer all over the world and the fourth common cause of cancer-specific mortality.Surgical management for rectal cancer is challenging due to the narrow pelvis and extreme proximity to contiguous organs hence, recurrence rates are commonly reported.

The advent of total mesorectal excision (TME) together with minimally invasive techniques such as laparoscopic colorectal surgery have not only improved surgical results but have also improved surgical technique, operative ability and surgical visibility. Lap TME has been shown to give similar results to the classical open approach with regard to peri-operative morbidity, surgical margins, quality of the surgical specimen, and number of resected lymph nodes, local recurrence and overall survival.

However, laparoscopic resection of mid and low rectal cancer is technically difficult due to tapering of the mesorectum in the pelvis and the forward angle of the distal rectum rendering this part of the rectum less accessible from the abdominal cavity. This may lead to incomplete mesorectal excision and involved circumferential resection margins (CRMs), with consequent local recurrences.Previous pelvic radiation can make laparoscopic pelvic dissection more difficult, and tumors located on the anterior rectal wall have an increased risk of inadequate oncological clearance. The use of laparoscopic staplers in a narrow pelvis is difficult and the multiple firings of staples across the low rectum is of concern.

Trans-anal Total Mesorectal Excision (TaTME) was recently developed to overcome technical difficulties associated with Lap TME and open TME. It may address some of the difficult aspects of laparoscopic or open TME, such as exposure, rectal dissection, and distal cross-stapling of the rectum and sphincter preservation. It does not only facilitate dissection of the difficult distal part of the TME dissection in the narrow pelvis but it also allows clear definition of safe, tumor-free, radial and longitudinal margins. Moreover, the specimen could be extracted through the anus excluding the need for minilaparotmy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Anesthetically fit patient.

2. Non metastatic pathologically proven rectal cancer (Mid-Low).

3. Patients who received neoadjuvant chemo-radiotherapy will be included

Exclusion Criteria:

1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.

2. Patients with cardiac or chest problems that cannot withstand CO2 insufflation.

3. Unresectable tumors (T4) (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).

4. Obstructed or perforated cancer.

5. Patients with unresectable metastatic rectal cancer.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Trans-anal total mesorectal excision(TaTME)
Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
• Lap. TME
Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection

Locations

Country	Name	City	State
Egypt	Oncology Center, Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23. — View Citation

Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. Review. — View Citation

Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4. — View Citation

Qu C, Yuan RF, Huang J, Liu L, Jiang CH, Yang ZQ, Shao JH. [Meta-analysis of laparoscopic versus open total mesorectal excision for middle and low rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Aug;16(8):748-52. Chinese. — View Citation

Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151. Review. — View Citation

Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;(4):CD005200. doi: 10.1002/14651858.CD005200.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumferential radial margin (CRM)	Percentage of participants with involved circumferential margin(pathological assessment)	2 years
Primary	Distal safety margin	Distance of free distal margin in mm (pathological assessment)	2 years
Primary	Number of lymph nodes retrieved	Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)	2 years
Secondary	Morbidity rate	Number of intra-operative and post-operative encountered complications	2 years
Secondary	Rate of conversion	Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases	2 years
Secondary	Disease free survival	Time till development of local or distant recurrence in months	30 months
Secondary	Functional outcome	Assessment of functional outcome via questionnaires	18 months