CClinicalTrials.gg
Status unknownNCT03171298Updated May 31, 2017

Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision

An interventional study of Laparoscopic Assisted Transanal Total Mesorectal Excision in Rectal Cancer, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or high body mass index . Difficult visualization of the pelvic anatomy along with the limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes and increase the risks of injuries during surgery. A down to up approach via transanal total mesorectal excision (TaTME) technique may overcome these problems

Read the detailed description

This clinical trial will be conducted at general surgery department of Assiut University Hospital .

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Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 100 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • rectal cancer histologically proven through biopsy

      • tumours located at least 3 cm from anorectal ring;
      • local spread restricted to the rectal wall
      • adequate preoperative sphincter function and continence;
      • absence of distant metastases.
      • Suitable for elective surgical resection

Exclusion criteria

Exclusion Criteria:

    • T4 tumours not responding to neoadjuvant chemo- radiotherapy

      • Patients under 18 years of age
      • Pregnancy
      • Previous rectal surgery (except local excision, endoscopic mucosal resection (EMR) or polypectomy)
      • Patients with acute intestinal obstruction
      • Multiple colorectal tumours
      • Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), Crohn's disease or ulcerative colitis
      • Planned synchronous abdominal organ resections
      • Preoperative evidence for distant metastases through imaging of the thorax and abdomen
      • Absolute contraindications to general anaesthesia,
      • presence of fecal incontinence,
      • undifferentiated tumors .
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    transanal TME

    Laparoscopic Assisted Transanal Total Mesorectal Excision

    Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision

Interventions

  • ProcedureLaparoscopic Assisted Transanal Total Mesorectal Excision

    * Abdominal approach with laparoscopic mobilization of the left colon * Laparoscopic isolation and transection of inferior mesenteric vessels . * Transabdominal dissection of the upper rectum and mesorectam. * Insertion of transanal platform and the creation of pneumorectum. * Occlusion of rectum 2 cm distal to the rectal lesion via purse string. * Transanal dissection of lower and mid mesorectam * The specimen will be extracted transanally

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What researchers measure

Primary outcomes

  1. intraoperative complication

    complication occured intraoperatively or on the first day of surgery

    Time frame: 1 day

Secondary outcomes

  1. resection margin

    circumferential resection margin microscopic examination

    Time frame: 1 years

  2. Mortality rate

    rate of death

    Time frame: 1 years

  3. morbidity rate

    rate of postoperative morbidity

    Time frame: 1 year

  4. recurrance rate

    rate of local recurance( by CT scan )

    Time frame: 2 years

  5. Anorectal function outcomes

    manometric assessment of anorectal function

    Time frame: 2 years

  6. Sexual functional outcomes

    sexual function with IIEF(International Index of Erectile Function) questionnaire

    Time frame: 2 years

  7. Mesorectal completeness

    The quality of the mesorectum or TME specimen(pathological examination)

    Time frame: 1 year

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Study locations

1 site
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References and documents

Publications

  • Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27. PubMed 26310534 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03171298
Lead sponsor
Assiut University
Responsible party
mohamed abulfetouh (Principal investigator, Assiut University) — Principal investigator
First posted
May 31, 2017
Start date
Jun 1, 2017 (estimated)
Primary completion
Mar 31, 2019 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
May 31, 2017

Study contacts

mohamed abulfetouh, MD
Contact
m.abulfetouh@aun.edu.eg
0201098904323
samir a ali, phd
study director · assuit university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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