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Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR). (MISS-TRICR)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic intersphincteric resection (LISR group)
Transanal minimally invasive Total mesorectal excision (TAMIS group)
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring low rectal cancer, minimally invasive colorectal surgery, trans-anal endoscopic microsurgery, TEM, intersphincteric resection, ISR, subtotal intersphincteric resection, total intersphincteric resection, trans-anal trans-abdominal resection, laparoscopic intersphincteric resection, anal sphincter preservation, total mesorectal excision, TME, TATA, laparoscopic total mesorectal excision, external sphincter preservation, Neoadjuvant chemo-radiotherapy for rectal cancer, fit patients for minimally invasive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with low rectal cancer below 5 cm from the anal verge
  • Fit (Medically and surgically) for laparoscopy.

Exclusion Criteria:

  • Patient with massive abdominal adhesions
  • Unfit for laparoscopy
  • Unwilling to share in the study

Sites / Locations

  • Oncology centre Of Mansoura University (OCMU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LISR group

TAMIS Group

Arm Description

Cases which undergo rectal resection with laparoscopic intersphincteric resection.

Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.

Outcomes

Primary Outcome Measures

Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation
Hospital stay
Hospital stay starting from the day of admission till discharge.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2015
Last Updated
July 1, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02488707
Brief Title
Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).
Acronym
MISS-TRICR
Official Title
Outcomes of Transanal Minimally Invasive TME Versus Laparoscopic Intersphincteric Resection Techniques for Rectal Cancer After Initial Neoadjuvant Chemo-radiotherapy: Double Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.
Detailed Description
Ideal surgery for rectal cancer should not only obtain adequate radial and circumferential margins, but also preserve normal sphincter function.In 1990, the results of a 'close shave' at anterior resection were reported, suggesting that a resection margin of 1 cm or less produced an oncological outcome similar to that of a resection margin greater than 1 cm. Sphincter preservation presents several advantages; The lower risk of intraoperative rectal perforation and positive circumferential margin than APR, the lower risk of damaging the pelvic branches of the pelvic autonomic nerve and The preservation of the body image that may increase quality of life. Recently, the clinical outcome of intersphincteric resection (ISR) as a laparoscopic approach (laparoscopic ISR) has been reported, but laparoscopic ISR for patients with bulky low rectal cancer remains challenging particularly for T3 tumors in patients with a narrow pelvis, because of the difficulty in understanding the accurate anatomy of the small pelvic cavity, in dissecting the TME or the tumor specific mesorectal excision (TSME) plane, and in transecting the lower rectum safely. Moreover, numerous studies have demonstrated that laparoscopic techniques have many advantages in colorectal surgery compared with open surgery. Although Radical resection is the gold standard for the treatment of rectal cancer, TEM offers the advantage of combining a minimally invasive technique with evident benefits in terms of postoperative morbidity and recovery, long-term functional outcomes and subsequently improved quality of life. Transanal Endoscopic Microsurgery (TEM) developed at 1984 and eliminated most of local transanal excision limitations and triggered a significant improvement in the local excision procedures of rectal lesions. While TEM became the 'gold standard' for the treatment of large rectal adenomas and early rectal cancer, there are special concerns about the lack of adequate lymphadenectomy. Preoperative chemoradiation therapy is widely used to treat locally advanced rectal cancer to increase resectability, and to enhance sphincter preservation, local control and possibly, survival rates. Surgery is performed six to eight weeks after radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
low rectal cancer, minimally invasive colorectal surgery, trans-anal endoscopic microsurgery, TEM, intersphincteric resection, ISR, subtotal intersphincteric resection, total intersphincteric resection, trans-anal trans-abdominal resection, laparoscopic intersphincteric resection, anal sphincter preservation, total mesorectal excision, TME, TATA, laparoscopic total mesorectal excision, external sphincter preservation, Neoadjuvant chemo-radiotherapy for rectal cancer, fit patients for minimally invasive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LISR group
Arm Type
Active Comparator
Arm Description
Cases which undergo rectal resection with laparoscopic intersphincteric resection.
Arm Title
TAMIS Group
Arm Type
Active Comparator
Arm Description
Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic intersphincteric resection (LISR group)
Other Intervention Name(s)
Laparoscopic total mesorectum excision with coloaanal anastomosis.
Intervention Description
the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum
Intervention Type
Procedure
Intervention Name(s)
Transanal minimally invasive Total mesorectal excision (TAMIS group)
Intervention Description
Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.
Primary Outcome Measure Information:
Title
Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation
Time Frame
within 30 days
Title
Hospital stay
Description
Hospital stay starting from the day of admission till discharge.
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with low rectal cancer below 5 cm from the anal verge Fit (Medically and surgically) for laparoscopy. Exclusion Criteria: Patient with massive abdominal adhesions Unfit for laparoscopy Unwilling to share in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama eldamshety, PhD
Organizational Affiliation
Assistant Lecturer of surgical oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherif Kotb, PhD, MD
Organizational Affiliation
Professor of surgical oncology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adel Fathi, PhD, MD
Organizational Affiliation
Lecturer of surgical oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology centre Of Mansoura University (OCMU)
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).

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