Rectal CancerNCT03171298
Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
A study testing Laparoscopic Assisted Transanal Total Mesorectal Excision in people with Rectal Cancer, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Laparoscopic Assisted Transanal Total Mesorectal Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 12Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit Universty Hospital
Asyut
samir a ali, PHD, 02088403255, samir.ali@med.au.edu.eg
About this study
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 .
.
- Conditions
- Rectal Cancer
- Being tested
- Laparoscopic Assisted Transanal Total Mesorectal Excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Assisted Transanal Total Mesorectal ExcisionProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| transanal TME | Experimental | Laparoscopic Assisted Transanal Total Mesorectal Excision Receives: Procedure: Laparoscopic Assisted Transanal Total Mesorectal Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complication
complication occured intraoperatively or on the first day of surgery
Measured: 1 day
Secondary outcomes (7)
resection margin
circumferential resection margin microscopic examination
Measured: 1 years
Mortality rate
rate of death
Measured: 1 years
morbidity rate
rate of postoperative morbidity
Measured: 1 year
recurrance rate
rate of local recurance( by CT scan )
Measured: 2 years
Anorectal function outcomes
manometric assessment of anorectal function
Measured: 2 years
Sexual functional outcomes
sexual function with IIEF(International Index of Erectile Function) questionnaire
Measured: 2 years
Mesorectal completeness
The quality of the mesorectum or TME specimen(pathological examination)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abulfetouh, Assiut University
- Investigators
- samir a ali, phd, Study director, assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171298
- Sponsor's protocol ID
- transanal surgical approach
- Status last verified
- May 2017
- First submitted
- 20 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT03171298
- Acronym / sponsor ID
- transanal surgical approach
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This clinical trial will be conducted at general surgery department of Assiut University Hospital .
.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transanal TME | Experimental | Procedure: Laparoscopic Assisted Transanal Total Mesorectal ExcisionLaparoscopic Assisted Transanal Total Mesorectal Excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • rectal cancer histologically proven through biopsy
Key exclusion criteria (12 listed)
- • T4 tumours not responding to neoadjuvant chemo- radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic 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 | Procedure or surgery | transanal TME |
Primary outcome
intraoperative complication
Time frame: 1 day
complication occured intraoperatively or on the first day of surgery
7 secondary outcomes
resection margin
Time frame: 1 years
Mortality rate
Time frame: 1 years
morbidity rate
Time frame: 1 year
recurrance rate
Time frame: 2 years
Anorectal function outcomes
Time frame: 2 years
Sexual functional outcomes
Time frame: 2 years
Mesorectal completeness
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 26310534Kang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samir a ali, phd study director
assuit university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Assisted Transanal Total Mesorectal Excision in people with Rectal Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed abulfetouh, MD (0201098904323, m.abulfetouh@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complication (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.