Rectal CarcinomaNCT04078828
PR in Endoscopic LAR for Rectal Cancer
A study testing Pelvic floor Reconstruction in people with Rectal Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- Pelvic floor Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Apr 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with histologically proven rectal adenocarcinoma
- tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
- Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
- Negative circumferential resection margin confirmed by MRI
- Performance status (ECOG) 0~1
- Written informed consent for participation in the trial
Who cannot join
- History of accepting lower abdominal surgery.
- More than one colorectal tumor
- Patients with unresectable distant metastasis or multiple metastases
- Received neoadjuvant radiotherapy before surgery
- Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- Patients and/or family members cannot understand and accept this study
- Non-rectal adenocarcinoma was confirmed by postoperative pathological examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Center of PLA
Chongqing, Chongqing Municipality, 400038
Tang Bo, M.D/Ph.D, +862368754167, tangtbo@sina.com
About this study
Official title: Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer
The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.
Read the detailed description
Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).
We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.
- Conditions
- Rectal Carcinoma
- Being tested
- Pelvic floor Reconstruction
- Keywords
- minimally invasive surgical
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor ReconstructionProcedure or surgery
Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.
| Study group | Role | What they receive |
|---|---|---|
| PR | Active comparator | Not described Receives: Procedure: Pelvic floor Reconstruction |
| Non-PR | Active comparator | Not described Receives: Procedure: Pelvic floor Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer
Measured: 30 days after surgery
Re-operation rate after anastomotic leakage
Measured: 30 days after surgery
The rate of general complications
Measured: 30 days after surgery
Secondary outcomes (10)
Operative time
Measured: Operation day
Postoperative hospital stay
Measured: 1 year after surgery
Incidence of defecation dysfunction
Measured: From the date of operation until the date of complication,assessed up to 3 years
3-year local recurrence rate
Measured: From date of operation until the date of local-recurrence (up to 3 years)
5-year disease-free survival
Measured: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Measured: 1 year after operation
Blood loss
Measured: Operation day
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Measured: 1 days after surgery
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Measured: 3 days after surgery
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Measured: 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Sep 2019
- Primary completion1 Aug 2020
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CarcinomaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Chuan, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078828
- Sponsor's protocol ID
- PRLAR-SURGERY
- Status last verified
- Nov 2021
- First submitted
- 15 Aug 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04078828
- Acronym / sponsor ID
- PRLAR-SURGERY
- Conditions
- Rectal Carcinoma
- Keywords
- minimally invasive surgical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Sep 2019 (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.
The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.
Detailed description
Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).
We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR | Active comparator | Procedure: Pelvic floor Reconstruction |
| Non-PR | Active comparator | Procedure: Pelvic floor Reconstruction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with histologically proven rectal adenocarcinoma
- tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
- Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
- Negative circumferential resection margin confirmed by MRI
- Performance status (ECOG) 0~1
Key exclusion criteria (7 listed)
- History of accepting lower abdominal surgery.
- More than one colorectal tumor
- Patients with unresectable distant metastasis or multiple metastases
- Received neoadjuvant radiotherapy before surgery
- Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
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 |
|---|---|---|
| Pelvic floor ReconstructionPelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished. | Procedure or surgery | Non-PR, PR |
Primary outcome
The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer
Time frame: 30 days after surgery
Re-operation rate after anastomotic leakage
Time frame: 30 days after surgery
The rate of general complications
Time frame: 30 days after surgery
10 secondary outcomes
Operative time
Time frame: Operation day
Postoperative hospital stay
Time frame: 1 year after surgery
Incidence of defecation dysfunction
Time frame: From the date of operation until the date of complication,assessed up to 3 years
3-year local recurrence rate
Time frame: From date of operation until the date of local-recurrence (up to 3 years)
5-year disease-free survival
Time frame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Time frame: 1 year after operation
Blood loss
Time frame: Operation day
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Time frame: 1 days after surgery
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Time frame: 3 days after surgery
White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
Time frame: 5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor Reconstruction in people with Rectal Carcinoma, 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 6 inclusion and 7 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 30 Nov 2021. 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 (+862368754167, tangtbo@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer (time frame: 30 days after surgery). The study lists 3 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 30 Nov 2021.