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

Phase 2

• Conditions: Rectal Cancer
• Interventions: Procedure: Transanal minimally invasive Total mesorectal excision (TAMIS group); Procedure: laparoscopic intersphincteric resection (LISR group)

• Registration Number: NCT02488707
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-06-27
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-01
• Last Update Submitted: 2015-07-01
• Study First Posted: 2015-07-02
• Last Update Posted: 2015-07-02
• Primary Completion: 2016-02
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAMIS Group	Transanal minimally invasive Total mesorectal excision (TAMIS group)	Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.
LISR group	laparoscopic intersphincteric resection (LISR group)	Cases which undergo rectal resection with laparoscopic intersphincteric resection.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Oncology centre Of Mansoura University (OCMU); 🇪🇬 Mansoura, Dakahlia, Egypt