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

Outcomes of Transanal Minimally Invasive TME Versus Laparoscopic Intersphincteric Resection Techniques for Rectal Cancer After Initial Neoadjuvant Chemo-radiotherapy: Double Blinded Study

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: laparoscopic intersphincteric resection (LISR group); Procedure: Transanal minimally invasive Total mesorectal excision (TAMIS group)

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Oncology centre Of Mansoura University (OCMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LISR group; Cases which undergo rectal resection with laparoscopic intersphincteric resection.	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; Other Names: Laparoscopic total mesorectum excision with coloaanal anastomosis.
Active Comparator: TAMIS Group; Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Osama eldamshety, PhD, Assistant Lecturer of surgical oncology; Study Chair: Sherif Kotb, PhD, MD, Professor of surgical oncology; Principal Investigator: Adel Fathi, PhD, MD, Lecturer of surgical oncology

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: June 27, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Estimate): July 2, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: total mesorectal excision; intersphincteric resection; TME; TEM; low rectal cancer; ISR; minimally invasive colorectal surgery; trans-anal endoscopic microsurgery; subtotal intersphincteric resection; total intersphincteric resection; trans-anal trans-abdominal resection; laparoscopic intersphincteric resection; anal sphincter preservation; TATA; laparoscopic total mesorectal excision; external sphincter preservation; Neoadjuvant chemo-radiotherapy for rectal cancer; fit patients for minimally invasive surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: MISS-TRICR