Colorectal CancerNOTESNCT02549456
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
A study testing natural orifice specimen extraction and Laparoendoscopic resection in people with Colorectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- natural orifice specimen extraction and Laparoendoscopic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medically fit patient.
- Non metastatic pathologically proven sigmoid colon cancer.
- Non metastatic pathologically proven rectal cancer.
- Patient continent for stool.
Who cannot join
- Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
- Patients with cardiac or chest problems that cannot withstand insufflation.
- Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
- Obstructed or perforated cancer.
- Patients with metastatic colorectal cancer.
- Incontinent patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology center Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Islam H Metwally, M.Sc, 01002985865 ext. 02, drislamhany@mans.edu.eg
Mohamed A Hegazy, MD
About this study
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
Read the detailed description
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- natural orifice specimen extraction, Laparoendoscopic resection
- Keywords
- natural orifice surgery, natural orifice specimen extraction, taTME
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural orifice specimen extractionProcedure or surgery
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
Laparoendoscopic resectionProcedure or surgery
Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length.
Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.
| Study group | Role | What they receive |
|---|---|---|
| Natural orifice specimen extraction | Experimental | Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction Receives: Procedure: natural orifice specimen extraction |
| Laparoendoscopic resection | Experimental | Laparoscopic assisted transanal endoscopic resection of rectal cancer Receives: Procedure: Laparoendoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Rate of conversion to classic laparoscopy or to open laparotomy.
Measured: 24 hour
operative time
time taken from starting operation till patient wake up
Measured: 24 hour
Operative blood loss
measured in milliliter
Measured: 24 hour
Wound complications
infection-dehiscence
Measured: two week
Major intraoperative complications
bleeding -organ injury
Measured: 24 hour
Major postoperative complications
leak-bleeding
Measured: two weeks
Secondary outcomes (5)
Adequacy of lymphadenectomy
Number of lymph nodes retrieved
Measured: one month
Grading of quality and completeness of mesorectal excision
It is a composite outcome where result will appear as either complete, near complete or incomplete. Criteria in (shape, coning, presence of defects and circumferential safety margin) will be integrated to categorize it.
Measured: one month
Longitudinal safety margin
either free or infiltrated with tumor by histopathology examination.
Measured: one month
short term oncologic outcome
incidence of local and distant outcomes and disease free survival
Measured: 6 months - one year
Functional outcome
assessing fecal incontinence using Kirwan's grading score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade da Coruña
- Responsible party
- Principal investigator, Islam Hany Metwally, Mansoura University
- Investigators
- Jose F Noguira, MD, Study director, Head of general and digestive surgery department, CHUAC, universidade da CorunaSherif Z Kotb, MD, Study chair, Professor of surgical oncology, Oncology center Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549456
- Sponsor's protocol ID
- MD/148
- Acronym
- NOTES
- Status last verified
- Mar 2017
- First submitted
- 29 Aug 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02549456
- Acronym / sponsor ID
- NOTES / MD/148
- Conditions
- Colorectal Cancer
- Keywords
- natural orifice surgery, natural orifice specimen extraction, taTME
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Universidade da Coruña
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 15 Sep 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.
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
Detailed description
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural orifice specimen extraction | Experimental | Procedure: natural orifice specimen extractionConventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction |
| Laparoendoscopic resection | Experimental | Procedure: Laparoendoscopic resectionLaparoscopic assisted transanal endoscopic resection of rectal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medically fit patient.
- Non metastatic pathologically proven sigmoid colon cancer.
- Non metastatic pathologically proven rectal cancer.
- Patient continent for stool.
Key exclusion criteria (6 listed)
- Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
- Patients with cardiac or chest problems that cannot withstand insufflation.
- Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
- Obstructed or perforated cancer.
- Patients with metastatic colorectal cancer.
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 |
|---|---|---|
| natural orifice specimen extractionConventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice). | Procedure or surgery | Natural orifice specimen extraction |
| Laparoendoscopic resectionEndoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length. Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed. | Procedure or surgery | Laparoendoscopic resection |
Primary outcome
Feasibility
Time frame: 24 hour
Rate of conversion to classic laparoscopy or to open laparotomy.
operative time
Time frame: 24 hour
time taken from starting operation till patient wake up
Operative blood loss
Time frame: 24 hour
measured in milliliter
Wound complications
Time frame: two week
infection-dehiscence
Major intraoperative complications
Time frame: 24 hour
bleeding -organ injury
Major postoperative complications
Time frame: two weeks
leak-bleeding
5 secondary outcomes
Adequacy of lymphadenectomy
Time frame: one month
Grading of quality and completeness of mesorectal excision
Time frame: one month
Longitudinal safety margin
Time frame: one month
short term oncologic outcome
Time frame: 6 months - one year
Functional outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Jose F Noguira, MD study director
Head of general and digestive surgery department, CHUAC, universidade da Coruna
Sherif Z Kotb, MD study chair
Professor of surgical oncology, Oncology center Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing natural orifice specimen extraction and Laparoendoscopic resection in people with Colorectal 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 4 inclusion and 6 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 24 Mar 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 Islam H Metwally, M.Sc (01002985865 ext. 02, dr.islamo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 24 hour). The study lists 6 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 24 Mar 2017.