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Search / Trial NCT01836926

TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

Launched by OSAMA MOHAMMAD ALI ELDAMSHETY · Apr 17, 2013

Trial Information

Current as of September 24, 2025

Completed

Keywords

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

ClinConnect Summary

During the period between April 2013 and July 2019, a non-randomized controlled study was performed at two tertiary centers; Oncology Centre of Mansoura University and Policlinico Umberto Primo surgery department of SAPIENZA university of Rome after referral from the clinical oncology and nuclear medicine department. After diagnosis of ultralow rectal cancer, a written informed consent was obtained from patients after full explanation of the procedure, the likely outcome and the potential complications that may occur. Digital rectal examination was conducted to assess the distance of lower ...

Gender

ALL

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.

About Osama Mohammad Ali Eldamshety

Osama Mohammad Ali Eldamshety is a dedicated clinical trial sponsor with extensive experience in managing and overseeing clinical research projects. Committed to advancing medical knowledge and improving patient outcomes, Mr. Eldamshety specializes in the design, implementation, and monitoring of clinical trials across various therapeutic areas. His strong leadership skills and in-depth understanding of regulatory requirements ensure that studies are conducted with the highest standards of integrity and compliance. With a focus on collaboration and innovation, he strives to foster partnerships that enhance the efficiency and effectiveness of clinical research initiatives.

Locations

Mansoura, El Dakahlia, Egypt

Mansoura, El Dakahlia, Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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