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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03242187
Acronym
MansTaTME
Enrollment
30
Registered
2017-08-08
Start date
2017-05-25
Completion date
2019-12-30
Last updated
2017-08-08

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

Conditions

Rectal Cancer

Keywords

Minimally invasive surgery, trans-anal total mesorectal excision, Laparoscopic total mesoretal excision

Brief 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.

Detailed 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.

Interventions

PROCEDURETrans-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)

PROCEDURELap. TME

Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Circumferential radial margin (CRM)2 yearsPercentage of participants with involved circumferential margin(pathological assessment)
Distal safety margin2 yearsDistance of free distal margin in mm (pathological assessment)
Number of lymph nodes retrieved2 yearsNumber of infiltrated/ Number of harvested lymph nodes(pathological assessment)

Secondary

MeasureTime frameDescription
Disease free survival30 monthsTime till development of local or distant recurrence in months
Rate of conversion2 yearsPercentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases
Functional outcome18 monthsAssessment of functional outcome via questionnaires
Morbidity rate2 yearsNumber of intra-operative and post-operative encountered complications

Countries

Egypt

Contacts

Primary ContactMohammad Z Metwally, Ass.Lecturer
mohammadzuhdy@gmail.com00201068683363
Backup ContactSameh R Abdelazeez, Professor
samehroshdy20@gmail.com

Outcome results

None listed

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