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

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02488707
• Other study ID #: MISS-TRICR
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: June 27, 2015
• Last updated: July 1, 2015
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• laparoscopic intersphincteric resection (LISR group)
the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum
• Transanal minimally invasive Total mesorectal excision (TAMIS group)
Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.

Locations

Country	Name	City	State
Egypt	Oncology centre Of Mansoura University (OCMU)	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation		within 30 days	Yes
Primary	Hospital stay	Hospital stay starting from the day of admission till discharge.	up to 30 days	No