Rectal CancerNCT03589131
Robotic-assisted Versus Conventional Laparoscopic Approach for Rectal Cancer Surgery
A study testing Total Operative time, Margin assessment and Conversion rate to open surgery in people with Rectal Cancer, run by National Cancer Institute, Egypt.
Trial summary
This is a prospective randomized controlled study that was conducted on patients of both sexes and definite age group at National Cancer Institute-Egypt and with adenocarcinoma of the rectum located within 15 cm from the anal verge. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Total Operative time, Margin assessment and Conversion rate to open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2015to 12 Jan 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- histological diagnosis of adenocarcinoma of rectum
- no anesthesiological contraindications to minimally invasive surgery
- age 16 -75 years,
- ASA ≤ 2 \&
- the procedures performed by the same surgical team.
Who cannot join
- Patients with metastatic disease,
- malignant bowel obstruction (MBO) and
- those with irresectable tumor
About this study
Official title: Robotic-assisted Versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, Randomized Controlled Trial (RCT)
This is a prospective randomized controlled study that was conducted on patients of both sexes and definite age group at National Cancer Institute-Egypt and with adenocarcinoma of the rectum located within 15 cm from the anal verge. Tumor localization was categorized as the upper rectum (distal border of tumor is from 10 to 15 cm from the anal verge), middle rectum (5 to 10 cm from the anal verge) or lower rectum (less than 5 cm from the anal verge) as measured by colonoscopy and digital rectal examination. Patients were classified into two groups; robotic assisted rectal surgery and conventional laparoscopic rectal surgery.Baseline demographics (gender, age, ASA, BMI), preoperative data (distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation (CRT), presence of residual tumor after CRT, intraoperative data (preparation time, actual operative time, estimated blood loss, conversion rate to open surgery), postoperative data (pathological stage, number of harvested lymph nodes, macroscopic completeness of resection in the form of proximal margin, distal margin, circumferential radial margin) and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of re-operation, rate of readmission \& 30-days mortality) were analyzed and compared.The criteria for patients selection were the following: histological diagnosis of adenocarcinoma of rectum, no anesthesiological contraindications to minimally invasive surgery, age ≤ 75 years, American Society of Anesthesiologists (ASA) ≤ 2 \& the procedures performed by the same surgical team. Patients with metastatic disease, malignant bowel obstruction and those with irresectable tumor were excluded from our study.Preoperative workup (endoscopy with biopsies, radiological imaging including pelvic MRI, liver ultrasound, chest X-ray and routine abdominal and digital rectal examinations) was routinely carried out. The assignment of patients to either group was done by a permuted block randomization. It was an open-labeled study. The study was approved by the institutional review board of National Cancer Institute-Cairo University. All patients provided written informed consent.
Read the detailed description
Undoubtedly, robotic systems have largely penetrated the surgical field.For any new operative approach to become an accepted alternative to conventional methods, it must be proved safe and result in comparable outcomes. The purpose of this study is to compare the short-term operative as well as oncologic outcomes of robotic assisted and laparoscopic rectal cancer resection.
This is a prospective randomized controlled study that was conducted on all patients of both sexes and definite age group attending the National Cancer Institute and with adenocarcinoma of the rectum located within 15 cm from the anal verge who were eligible to be included in the study. Tumor localization was categorized as the upper rectum (distal border of tumor is from 10 to 15 cm from the anal verge), middle rectum (5 to 10 cm from the anal verge) or lower rectum (less than 5 cm from the anal verge) as measured by colonoscopy and digital rectal examination. Patients were classified into two groups; robotic assisted rectal surgery "The robotic system that we use is the da Vinci Si(Intuitive Surgical, Inc.,Sunnyvale,CA)" and conventional laparoscopic rectal surgery. Baseline demographics (gender, age, ASA, BMI), preoperative data (distance of the tumor from the anal verge, clinical stage, whether preoperative chemo-radiation "CRT", presence of residual tumor after CRT), intraoperative data (preparation time, actual operative time, estimated blood loss, conversion rate to open surgery), postoperative data (pathological stage, number of harvested lymph nodes, macroscopic completeness of resection in the form of proximal margin, distal margin, circumferential radial margin) and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus, wound problems and others, rate of reoperation, rate of readmission \& 30-days mortality) were analyzed and compared.The criteria for patients selection were the following: histological diagnosis of adenocarcinoma of rectum, no anesthesiological contraindications to minimally invasive surgery, age ≤ 75 years, ASA ≤ 2 \& the procedures performed by the same surgical team. Patients with metastatic disease, malignant bowel obstruction (MBO) and those with irresectable tumor were excluded from our study. Preoperative workup (endoscopy with biopsies, radiological imaging including pelvic MRI, liver ultrasound, chest X-ray and routine abdominal and digital rectal examinations) was routinely carried out. The assignment of patients to either group was done by a permuted block randomization. It was an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors knew which procedure will be done to which patients. The study was approved by the institutional review board of the National Cancer Institute, Cairo University. All patients provided written informed consent.
- Conditions
- Rectal Cancer
- Being tested
- Total Operative time, Margin assessment, Conversion rate to open surgery, Baseline demographics, Preoperative data
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Operative timeProcedure or surgery
Investigators compare the preparation time of the procedure in the operating room and the actual operative time
Margin assessmentProcedure or surgery
In this intervention investigators measure the proximal, distal and the important circumferential radial margin away from the tumor to determine if this arm is oncologically safe or not.
Conversion rate to open surgeryProcedure or surgery
In this interversion investigators try to measure how much is this arm feasible to completely perform the procedure whether robotically or laparoscopically without conversion to open surgery
Baseline demographicsProcedure or surgery
These include gender, age, ASA and BMI. All these data are analyzed and compared in both groups
Preoperative dataProcedure or surgery
These include distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation "CRT", presence of residual tumor after CRT. All were analyzed and compared
Postoperative dataProcedure or surgery
These include pathological stage, number of harvested lymph nodes and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of reoperation, rate of readmission \& 30-days mortality. All were analyzed and compared
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted Surgery Group | Active comparator | In this arm the investigators use a robotic system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe. The robotic system that we use is the da Vinci Si (Intuitive Surgical, Inc.,Sunnyvale,CA) Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data Receives: Procedure: Total Operative time; Procedure: Margin assessment; Procedure: Conversion rate to open surgery; Procedure: Baseline demographics; Procedure: Preoperative data; Procedure: Postoperative data |
| Laparoscopic Surgery Group | Active comparator | In this arm the investigators use a Laparoscopy system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe.
Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data Receives: Procedure: Total Operative time; Procedure: Margin assessment; Procedure: Conversion rate to open surgery; Procedure: Baseline demographics; Procedure: Preoperative data; Procedure: Postoperative data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time of robotic-assisted rectal cancer surgery.
Comparison of operative time in each arm
Measured: 30 days postoperative
Secondary outcomes (1)
Accurate safety margin
the surgical margins are considered adequate if the proximal, distal and circumferential radial margins are at least 5 cm, 2 cm and 0.1 cm respectively
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start29 Apr 2015
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasser A Debakey, Msc, Principal investigator, Assistant Teacher of Surgical Oncology, National Cancer Institute, Cairo University,Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589131
- Sponsor's protocol ID
- Debakey1
- Status last verified
- Jul 2018
- First submitted
- 31 May 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT03589131
- Acronym / sponsor ID
- Debakey1
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 17 Jul 2018 (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.
This is a prospective randomized controlled study that was conducted on patients of both sexes and definite age group at National Cancer Institute-Egypt and with adenocarcinoma of the rectum located within 15 cm from the anal verge. Tumor localization was categorized as the upper rectum (distal border of tumor is from 10 to 15 cm from the anal verge), middle rectum (5 to 10 cm from the anal verge) or lower rectum (less than 5 cm from the anal verge) as measured by colonoscopy and digital rectal examination. Patients were classified into two groups; robotic assisted rectal surgery and conventional laparoscopic rectal surgery.Baseline demographics (gender, age, ASA, BMI), preoperative data (distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation (CRT), presence of residual tumor after CRT, intraoperative data (preparation time, actual operative time, estimated blood loss, conversion rate to open surgery), postoperative data (pathological stage, number of harvested lymph nodes, macroscopic completeness of resection in the form of proximal margin, distal margin, circumferential radial margin) and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of re-operation, rate of readmission \& 30-days mortality) were analyzed and compared.The criteria for patients selection were the following: histological diagnosis of adenocarcinoma of rectum, no anesthesiological contraindications to minimally invasive surgery, age ≤ 75 years, American Society of Anesthesiologists (ASA) ≤ 2 \& the procedures performed by the same surgical team. Patients with metastatic disease, malignant bowel obstruction and those with irresectable tumor were excluded from our study.Preoperative workup (endoscopy with biopsies, radiological imaging including pelvic MRI, liver ultrasound, chest X-ray and routine abdominal and digital rectal examinations) was routinely carried out. The assignment of patients to either group was done by a permuted block randomization. It was an open-labeled study. The study was approved by the institutional review board of National Cancer Institute-Cairo University. All patients provided written informed consent.
Detailed description
Undoubtedly, robotic systems have largely penetrated the surgical field.For any new operative approach to become an accepted alternative to conventional methods, it must be proved safe and result in comparable outcomes. The purpose of this study is to compare the short-term operative as well as oncologic outcomes of robotic assisted and laparoscopic rectal cancer resection.
This is a prospective randomized controlled study that was conducted on all patients of both sexes and definite age group attending the National Cancer Institute and with adenocarcinoma of the rectum located within 15 cm from the anal verge who were eligible to be included in the study. Tumor localization was categorized as the upper rectum (distal border of tumor is from 10 to 15 cm from the anal verge), middle rectum (5 to 10 cm from the anal verge) or lower rectum (less than 5 cm from the anal verge) as measured by colonoscopy and digital rectal examination. Patients were classified into two groups; robotic assisted rectal surgery "The robotic system that we use is the da Vinci Si(Intuitive Surgical, Inc.,Sunnyvale,CA)" and conventional laparoscopic rectal surgery. Baseline demographics (gender, age, ASA, BMI), preoperative data (distance of the tumor from the anal verge, clinical stage, whether preoperative chemo-radiation "CRT", presence of residual tumor after CRT), intraoperative data (preparation time, actual operative time, estimated blood loss, conversion rate to open surgery), postoperative data (pathological stage, number of harvested lymph nodes, macroscopic completeness of resection in the form of proximal margin, distal margin, circumferential radial margin) and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus, wound problems and others, rate of reoperation, rate of readmission \& 30-days mortality) were analyzed and compared.The criteria for patients selection were the following: histological diagnosis of adenocarcinoma of rectum, no anesthesiological contraindications to minimally invasive surgery, age ≤ 75 years, ASA ≤ 2 \& the procedures performed by the same surgical team. Patients with metastatic disease, malignant bowel obstruction (MBO) and those with irresectable tumor were excluded from our study. Preoperative workup (endoscopy with biopsies, radiological imaging including pelvic MRI, liver ultrasound, chest X-ray and routine abdominal and digital rectal examinations) was routinely carried out. The assignment of patients to either group was done by a permuted block randomization. It was an open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors knew which procedure will be done to which patients. The study was approved by the institutional review board of the National Cancer Institute, Cairo University. All patients provided written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted Surgery Group | Active comparator | Procedure: Total Operative time, Procedure: Margin assessment, Procedure: Conversion rate to open surgery, Procedure: Baseline demographics, Procedure: Preoperative data, Procedure: Postoperative dataIn this arm the investigators use a robotic system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe. The robotic system that we use is the da Vinci Si (Intuitive Surgical, Inc.,Sunnyvale,CA) Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data |
| Laparoscopic Surgery Group | Active comparator | Procedure: Total Operative time, Procedure: Margin assessment, Procedure: Conversion rate to open surgery, Procedure: Baseline demographics, Procedure: Preoperative data, Procedure: Postoperative dataIn this arm the investigators use a Laparoscopy system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe. Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- histological diagnosis of adenocarcinoma of rectum
- no anesthesiological contraindications to minimally invasive surgery
- age 16 -75 years,
- ASA ≤ 2 \&
- the procedures performed by the same surgical team.
Key exclusion criteria (3 listed)
- Patients with metastatic disease,
- malignant bowel obstruction (MBO) and
- those with irresectable tumor
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 |
|---|---|---|
| Total Operative timeInvestigators compare the preparation time of the procedure in the operating room and the actual operative time | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
| Margin assessmentIn this intervention investigators measure the proximal, distal and the important circumferential radial margin away from the tumor to determine if this arm is oncologically safe or not. | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
| Conversion rate to open surgeryIn this interversion investigators try to measure how much is this arm feasible to completely perform the procedure whether robotically or laparoscopically without conversion to open surgery | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
| Baseline demographicsThese include gender, age, ASA and BMI. All these data are analyzed and compared in both groups | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
| Preoperative dataThese include distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation "CRT", presence of residual tumor after CRT. All were analyzed and compared | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
| Postoperative dataThese include pathological stage, number of harvested lymph nodes and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of reoperation, rate of readmission \& 30-days mortality. All were analyzed and compared | Procedure or surgery | Laparoscopic Surgery Group, Robotic-assisted Surgery Group |
Primary outcome
Operative time of robotic-assisted rectal cancer surgery.
Time frame: 30 days postoperative
Comparison of operative time in each arm
1 secondary outcome
Accurate safety margin
Time frame: 30 days postoperative
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 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yasser A Debakey, Msc principal investigator
Assistant Teacher of Surgical Oncology, National Cancer Institute, Cairo University,Egypt.
Questions about this trial
What is this clinical trial studying?
A study testing Total Operative time, Margin assessment and Conversion rate to open surgery in people with Rectal Cancer, run by National Cancer Institute, 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 5 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: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Operative time of robotic-assisted rectal cancer surgery. (time frame: 30 days postoperative). 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 17 Jul 2018.