Adenocarcinoma of the RectumNCT01340755
Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
A study testing Transanal endoscopic surgery in people with Adenocarcinoma of the Rectum, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Rectum
- What is being tested?
- Transanal endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2017
- 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
- Biopsy-proven adenocarcinoma of the rectum
- Eligible to undergo standard open or laparoscopic low anterior resection with a temporary diverting stoma
- Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
- Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
- Rectal cancer located 4-12 cm from the anal verge
- ECOG performance status 2 or less
Who cannot join
- Metastasis
- Obstructing rectal cancer
- Synchronous colon cancer
- T3 rectal cancer not treated preoperatively with full-course chemoradiation
- Pregnant or breast-feeding
- Receiving any other study agents
Show all 15Show fewer
- Fecal incontinence
- History of prior colorectal cancer
- History of inflammatory bowel disease
- History of pelvic radiation
- Prior pelvic surgery or multiple abdominal procedures
- BMI > 30
- Large uterine fibroids
- Uncontrolled intercurrent illness
- Other malignancies diagnosed within the previous year, except basal cell cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.
Read the detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
- Conditions
- Adenocarcinoma of the Rectum
- Being tested
- Transanal endoscopic surgery
- Keywords
- Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal endoscopic surgeryProcedure or surgery
Laparoscopy-assisted transanal endoscopic rectosigmoid resection
| Study group | Role | What they receive |
|---|---|---|
| Transanal endoscopic surgery | Experimental | Laparoscopy-assisted transanal endoscopic rectosigmoid resection Receives: Procedure: Transanal endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
Measured: 1-5 years
Secondary outcomes (3)
Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
Measured: 1-5 years
Incidence of long-term complications
Measured: 1-5 years
Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2017
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 Adenocarcinoma of the RectumStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Sylla, Massachusetts General Hospital
- Investigators
- Patricia Sylla, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340755
- Sponsor's protocol ID
- 10-409
- Status last verified
- Sep 2017
- First submitted
- 21 Apr 2011
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sylla P, Bordeianou LG, Berger D, Han KS, Lauwers GY, Sahani DV, Sbeih MA, Lacy AM, Rattner DW. A pilot study of natural orifice transanal endoscopic total mesorectal excision with laparoscopic assistance for rectal cancer. Surg Endosc. 2013 Sep;27(9):3396-405. doi: 10.1007/s00464-013-2922-7. Epub 2013 Apr 10.
PubMed 23572214
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01340755
- Acronym / sponsor ID
- 10-409
- Conditions
- Adenocarcinoma of the Rectum
- Keywords
- Rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Apr 2011 (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.
Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.
Detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transanal endoscopic surgery | Experimental | Procedure: Transanal endoscopic surgeryLaparoscopy-assisted transanal endoscopic rectosigmoid resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy-proven adenocarcinoma of the rectum
- Eligible to undergo standard open or laparoscopic low anterior resection with a temporary diverting stoma
- Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
- Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
- Rectal cancer located 4-12 cm from the anal verge
Key exclusion criteria (15 listed)
- Metastasis
- Obstructing rectal cancer
- Synchronous colon cancer
- T3 rectal cancer not treated preoperatively with full-course chemoradiation
- Pregnant or breast-feeding
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 |
|---|---|---|
| Transanal endoscopic surgeryLaparoscopy-assisted transanal endoscopic rectosigmoid resection | Procedure or surgery | Transanal endoscopic surgery |
Primary outcome
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.
Time frame: 1-5 years
3 secondary outcomes
Incidence of 30-day perioperative complications including intraoperative, surgical postoperative, and medical postoperative complications.
Time frame: 1-5 years
Incidence of long-term complications
Time frame: 1-5 years
Oncologic outcomes in subjects receiving transanal endoscopic rectosigmoid resection
Time frame: 1-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 23572214Sylla P, Bordeianou LG, Berger D, Han KS, Lauwers GY, Sahani DV, Sbeih MA, Lacy AM, Rattner DW. A pilot study of natural orifice transanal endoscopic total mesorectal excision with laparoscopic assistance for rectal cancer. Surg Endosc. 2013 Sep;27(9):3396-405. doi: 10.1007/s00464-013-2922-7. Epub 2013 Apr 10.
- 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.
Patricia Sylla, MD principal investigator
Massachusetts General 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 Transanal endoscopic surgery in people with Adenocarcinoma of the Rectum, run by Massachusetts General Hospital at 1 site in United States.
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 15 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: finished, as of the sponsor's last update on 6 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequacy of the total mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens. (time frame: 1-5 years). 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 NCT01340755, 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 6 Sep 2017.