TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy. (TaTME)
Rectal Cancer
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring sphincter sparing procedures, intersphincteric resection, rectal cancer, ultralow rectal cancer, sphincter preserving procedures, Abdominoperineal resection, Trans-anal minimally invasive surgery, TAMIS versus open colorectal resection, neoadjuvant chemo-radiotherapy for rectal cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with low rectal carcinoma(The lowest margin of tumor located 3 cm from anal verge ; ≤ 2 cm from dentate lines; 1 cm from anorectal rings.
- Local spread restricted to the rectal wall or the internal anal sphincter.
- Adequate preoperative sphincter function and continence.
- Absence of distant metastasis.
Exclusion Criteria:
- Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4.
- Metastatic rectal cancer.
- Those in Dukes stage D (T4 lesion).
- Undifferentiated tumours.
- Local infiltration of external anal sphincter or levator ani muscles.
- Tumor located more than 2 cm above the dentate line.
- Presence of fecal incontinence.
- Patients unwilling to take part in the study.
Sites / Locations
- Mansoura oncology centre
- Mansoura university oncology centre
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Open intersphincteric resection
laparoscopic intersphincteric resection .
surgical Instruments for open approach intervention: Open laparotomy through abdominal incision and mobilization of the colon and rectum up to the splenic flexure with high ligation of the inferior mesenteric vessels and mesorectal excision till the levator ani then the peranal approach to resect the distal margin of the rectum through high or low intersphincteric resection in the plane between internal and external anal sphincters.
instruments used: 4 or 5 laparoscopic trocars (two or three (10-mm) trocar, Two 5-mm trocars and a 12-mm trocar with reducers),Three 5-mm fenestrated grasping forceps, Five-millimetre coagulating shears, a 5-mm straight grasping forceps, Harmonic scalpel, 5 or 10 mm, a 10-mm fenestrated forceps, a 10-mm dissector,5 mm Bipolar grasper, a 5-mm needle holder, Twelve-millimetre linear staplers intervention: Trocar Placement and Exposure Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels Taking Down the Splenic Flexure rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.