Clinical trial NCT02488707: Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: 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
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation
timeFrame: within 30 days
measure: Hospital stay
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncology centre Of Mansoura University (OCMU)
state: Dakahlia
Study officials:
affiliation: Assistant Lecturer of surgical oncology
name: Osama eldamshety, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of surgical oncology
name: Sherif Kotb, PhD, MD
role: STUDY_CHAIR
affiliation: Lecturer of surgical oncology
name: Adel Fathi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: