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临床试验/NCT03242187
NCT03242187Unknown2 期

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月25日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
30
试验地点
1
主要终点
Number of lymph nodes retrieved

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anesthetically fit patient.
  • Non metastatic pathologically proven rectal cancer (Mid-Low).
  • Patients who received neoadjuvant chemo-radiotherapy will be included

排除标准

  • Patients with American Society of Anesthesiologist (ASA) score 4 and
  • Patients with cardiac or chest problems that cannot withstand CO2 insufflation.
  • 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).
  • Obstructed or perforated cancer.
  • Patients with unresectable metastatic rectal cancer.

研究组 & 干预措施

Trans-anal TME (TaTME)

Experimental

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)

干预措施: Trans-anal total mesorectal excision(TaTME) (Procedure)

Lap. TME

Active Comparator

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

干预措施: Lap. TME (Procedure)

结局指标

主要结局

Number of lymph nodes retrieved

时间窗: 2 years

Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)

Distal safety margin

时间窗: 2 years

Distance of free distal margin in mm (pathological assessment)

Circumferential radial margin (CRM)

时间窗: 2 years

Percentage of participants with involved circumferential margin(pathological assessment)

次要结局

  • Morbidity rate(2 years)
  • Disease free survival(30 months)
  • Rate of conversion(2 years)
  • Functional outcome(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Zuhdy

Assistant Lecturer

Mansoura University

研究点 (1)

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