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

NCT ID: NCT02488707

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-04-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LISR group

Cases which undergo rectal resection with laparoscopic intersphincteric resection.

Group Type: ACTIVE_COMPARATOR

laparoscopic intersphincteric resection (LISR group)

Intervention Type: PROCEDURE

the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum

TAMIS Group

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

Group Type: ACTIVE_COMPARATOR

Transanal minimally invasive Total mesorectal excision (TAMIS group)

Intervention Type: PROCEDURE

Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic total mesorectum excision with coloaanal anastomosis.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Osama Mohammad Ali ElDamshety

associate lecturer of surgical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama eldamshety, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer of surgical oncology

Sherif Kotb, PhD, MD

Role: STUDY_CHAIR

Professor of surgical oncology

Adel Fathi, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of surgical oncology

Locations

Oncology centre Of Mansoura University (OCMU)

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MISS-TRICR

Identifier Type: -

Identifier Source: org_study_id