Rectal CancerPhase 2MISS-TRICRNCT02488707
Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).
A Phase 2 study testing laparoscopic intersphincteric resection (LISR group) and Transanal minimally invasive Total mesorectal excision (TAMIS group) in people with Rectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial 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. 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 intersphincteric resection (LISR group) and Transanal minimally invasive Total mesorectal excision (TAMIS group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2014to Apr 2016
- Phase
- Phase 2
- 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
- Patient with low rectal cancer below 5 cm from the anal verge
- Fit (Medically and surgically) for laparoscopy.
Who cannot join
- Patient with massive abdominal adhesions
- Unfit for laparoscopy
- Unwilling to share in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oncology centre Of Mansoura University (OCMU)
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Outcomes of Transanal Minimally Invasive TME Versus Laparoscopic Intersphincteric Resection Techniques for Rectal Cancer After Initial Neoadjuvant Chemo-radiotherapy: Double Blinded Study
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- laparoscopic intersphincteric resection (LISR group), Transanal minimally invasive Total mesorectal excision (TAMIS group)
- 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
- 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 intersphincteric resection (LISR group)Procedure or surgery
Also called Laparoscopic total mesorectum excision with coloaanal anastomosis.
the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum
Transanal minimally invasive Total mesorectal excision (TAMIS group)Procedure or surgery
Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.
| Study group | Role | What they receive |
|---|---|---|
| LISR group | Active comparator | Cases which undergo rectal resection with laparoscopic intersphincteric resection. Receives: Procedure: laparoscopic intersphincteric resection (LISR group) |
| TAMIS Group | Active comparator | Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision. Receives: Procedure: Transanal minimally invasive Total mesorectal excision (TAMIS group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation
Measured: within 30 days
Hospital stay
Hospital stay starting from the day of admission till discharge.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Mohammad Ali ElDamshety, Mansoura University
- Investigators
- Osama eldamshety, PhD, Principal investigator, Assistant Lecturer of surgical oncologySherif Kotb, PhD, MD, Study chair, Professor of surgical oncologyAdel Fathi, PhD, MD, Principal investigator, Lecturer of surgical oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488707
- Sponsor's protocol ID
- MISS-TRICR
- Acronym
- MISS-TRICR
- Status last verified
- Jul 2015
- First submitted
- 27 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transanal Minimally Invasive TME Versus Laparoscopic Intersphincteric Resection Techniques for Rectal Cancer After Initial Neoadjuvant Chemo-radiotherapy: Double Blinded Study
- ClinicalTrials.gov ID
- NCT02488707
- Acronym / sponsor ID
- MISS-TRICR / MISS-TRICR
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LISR group | Active comparator | Procedure: laparoscopic intersphincteric resection (LISR group)Cases which undergo rectal resection with laparoscopic intersphincteric resection. |
| TAMIS Group | Active comparator | Procedure: Transanal minimally invasive Total mesorectal excision (TAMIS group)Cases with rectal cancer which undergo Transanal minimally invasive 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 (2 listed)
- Patient with low rectal cancer below 5 cm from the anal verge
- Fit (Medically and surgically) for laparoscopy.
Key exclusion criteria (3 listed)
- Patient with massive abdominal adhesions
- Unfit for laparoscopy
- Unwilling to share in the study
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 intersphincteric resection (LISR group)Also: Laparoscopic total mesorectum excision with coloaanal anastomosis.the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum | Procedure or surgery | LISR group |
| Transanal minimally invasive Total mesorectal excision (TAMIS group)Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization. | Procedure or surgery | TAMIS Group |
Primary outcome
Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation
Time frame: within 30 days
Hospital stay
Time frame: up to 30 days
Hospital stay starting from the day of admission till discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Osama eldamshety, PhD principal investigator
Assistant Lecturer of surgical oncology
Sherif Kotb, PhD, MD study chair
Professor of surgical oncology
Adel Fathi, PhD, MD principal investigator
Lecturer of surgical oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laparoscopic intersphincteric resection (LISR group) and Transanal minimally invasive Total mesorectal excision (TAMIS group) in people with Rectal Cancer, run by Mansoura 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 2 inclusion and 3 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 2 Jul 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Intraoperative and postoperative morbidity within 30 days starting from the time of the operation (time frame: within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2015.