Rectum CancerNCT03699761
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
A study testing Closure of the pelvic peritoneum and Nonclosure of the pelvic peritoneum in people with Rectum Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Closure of the pelvic peritoneum and Nonclosure of the pelvic peritoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Matching the diagnostic criteria of rectal adenocarcinoma
- Laparoscopic or robotic radical surgery for rectal cancer
- Preoperative TNM staging T1-3N0-2M0
- No history of malignant tumors by preoperative examination
- Middle and low rectal cancer
- Tumor size of 4 cm or less
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- ASA 1-3 scores
- Written informed consent by the patient
- The patient is willing to randomize to any group
Who cannot join
- Previous abdominal surgery
- Past malignant tumor history
- Preoperative examination suggests distant metastasis
- Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
- Emergency operation
- Elimination criteria
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- The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
- The anastomosis is located above the peritoneum reflex
- Intraoperative conversion to laparotomy
- Change the surgical method to perform Miles or Hartmann surgery
- Postoperative pathologically confirmed non-adenocarcinoma
- The patient asked to withdraw
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Center of PLA
Chongqing, 400038
Tang Bo, M.D/Ph.D, +862368754167, tangtbo@sina.com
About this study
Official title: Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
- Conditions
- Rectum Cancer
- Being tested
- Closure of the pelvic peritoneum, Nonclosure of the pelvic peritoneum
- Keywords
- Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the pelvic peritoneumProcedure or surgery
Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Nonclosure of the pelvic peritoneumProcedure or surgery
Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Peritonization | Experimental | Not described Receives: Procedure: Closure of the pelvic peritoneum; Procedure: Nonclosure of the pelvic peritoneum |
| Without Pelvic Peritonization | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III-IV complications
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
Measured: 30 days
Secondary outcomes (15)
Rate of reoperation
The rate of reoperation after leakage
Measured: 30 days
Detection of inflammation markers
C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Measured: 7 days
The rate of anastomotic leakage
Clinical diagnostic criteria for anastomotic leakage: 1. Abdominal and systemic infection symptoms: abdominal pain, bloating, fever, elevated white blood cells, PCT, CRP and other inflammation indicators; 2. Gas, pus, feces passing through the pelvic drainage tube, abdominal incision, etc.
Measured: 30 days
Hospital time
Comparison of hospital stay between the two groups
Measured: 30 days
Overall complication rate
Overall complication rate include I-IV grade
Measured: 30days
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation
Measured: 1 day
Operation time
The time from start to end of surgery
Measured: 1 day
Postoperative bleeding
Postoperative intra-abdominal bleeding
Measured: 7 days
Intestinal obstruction
Incidence of intestinal obstruction caused by various reasons after surgery
Measured: 30 days
Readmission rate
Rate of hospital readmissions due to complications after discharge
Measured: 30 days
LARS
Low Anterior resection syndrome caused by rectal surgery
Measured: 12 months
Acute inflammatory Response
Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Measured: 7 days
Acute inflammatory Response
Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Measured: 7 days
Detection of other inflammation markers
interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Measured: 7 days
Treatment cost
Comparison of cost between the two groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Sep 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Bo, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699761
- Sponsor's protocol ID
- POLAR
- Status last verified
- May 2023
- First submitted
- 5 Oct 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT03699761
- Acronym / sponsor ID
- POLAR
- Conditions
- Rectum Cancer
- Keywords
- Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 9 Oct 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.
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Peritonization | Experimental | Procedure: Closure of the pelvic peritoneum, Procedure: Nonclosure of the pelvic peritoneum |
| Without Pelvic Peritonization | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Matching the diagnostic criteria of rectal adenocarcinoma
- Laparoscopic or robotic radical surgery for rectal cancer
- Preoperative TNM staging T1-3N0-2M0
- No history of malignant tumors by preoperative examination
- Middle and low rectal cancer
Key exclusion criteria (12 listed)
- Previous abdominal surgery
- Past malignant tumor history
- Preoperative examination suggests distant metastasis
- Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
- Emergency operation
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 |
|---|---|---|
| Closure of the pelvic peritoneumClosure of the pelvic peritoneum after anastomosis for middle-low rectal caner. | Procedure or surgery | Pelvic Peritonization |
| Nonclosure of the pelvic peritoneumNonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner. | Procedure or surgery | Pelvic Peritonization |
Primary outcome
Grade III-IV complications
Time frame: 30 days
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
15 secondary outcomes
Rate of reoperation
Time frame: 30 days
Detection of inflammation markers
Time frame: 7 days
The rate of anastomotic leakage
Time frame: 30 days
Hospital time
Time frame: 30 days
Overall complication rate
Time frame: 30days
Estimated blood loss
Time frame: 1 day
Operation time
Time frame: 1 day
Postoperative bleeding
Time frame: 7 days
Intestinal obstruction
Time frame: 30 days
Readmission rate
Time frame: 30 days
LARS
Time frame: 12 months
Acute inflammatory Response
Time frame: 7 days
Acute inflammatory Response
Time frame: 7 days
Detection of other inflammation markers
Time frame: 7 days
Treatment cost
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the pelvic peritoneum and Nonclosure of the pelvic peritoneum in people with Rectum Cancer, run by Southwest Hospital, China at 1 site in China.
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 9 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 6 May 2023. 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 China. 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 Tang Bo, MD (+8613883902288, tangtbo@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade III-IV complications (time frame: 30 days). 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 6 May 2023.