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Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

NCT ID: NCT04573738

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-09-30

Brief Summary

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Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.

Detailed Description

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TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.

Conditions

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Rectal Cancer Perioperative Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic transanal surgery

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Group Type EXPERIMENTAL

Robotic assisted transanal total mesorectal excision

Intervention Type PROCEDURE

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Laparoscopic transanal surgery

Laparoscopic transanal total mesorectal excision for rectal cancer patients

Group Type ACTIVE_COMPARATOR

Laparoscopic assisted transanal total mesorectal excision

Intervention Type PROCEDURE

Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients

Interventions

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Robotic assisted transanal total mesorectal excision

Robotic assisted transanal total mesorectal excision for rectal cancer patients

Intervention Type PROCEDURE

Laparoscopic assisted transanal total mesorectal excision

Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Pathological biopsy confirmed adenocarcinoma of the rectum.
2. Preoperative assessment of tolerance to surgery without major organ dysfunction.
3. Patients must be able to understand and voluntarily sign written informed consent.
4. The surgical method is robotic assisted transanal total mesorectal excision
5. Distance of the edge of the tumour within 8 cm

Exclusion Criteria

1. The patient cannot tolerate the operation.
2. Refusal to sign informed consent.
3. Patients with distant metastasis of rectal cancer.
4. The surgical method was changed to miles or Hartman;
5. Unable to complete the follow - up
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weidong Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weidong Tong, MD

Role: STUDY_CHAIR

Army Military Medical University

Locations

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Daping hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.

Reference Type BACKGROUND
PMID: 29916871 (View on PubMed)

Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.

Reference Type BACKGROUND
PMID: 29067426 (View on PubMed)

Atallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24.

Reference Type BACKGROUND
PMID: 24957360 (View on PubMed)

Ye J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese.

Reference Type BACKGROUND
PMID: 28836251 (View on PubMed)

Other Identifiers

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20200913

Identifier Type: -

Identifier Source: org_study_id