Rectal CancerNCT05502354
CRP-guided Transanal Drainage Removal After Rectal Surgery
A study testing removal of transanal drainage tube in people with Rectal Cancer and Anastomotic Leak, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Anastomotic Leak
- What is being tested?
- removal of transanal drainage tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Feb 2025
- 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
- age from 18 to 75 years old
- male and female
- primary rectal adenocarcinoma
- ASA I, II, or III
- laparoscopic LAR + DST
- with or without preoperative radio- or chemotherapy
Show all 10Show fewer
- no distal metastasis
- no preoperative bowel obstruction
- no preventive ileostomy or colostomy
- patients and their families can understand and are willing to participate in this study and provide written informed consent
Who cannot join
- emergency operation
- preoperative abnormal liver function
- tatme or ISR procedure (healing process might differ from anterior resection)
- severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
- severe perioperative infection unrelated to anastomotic leak
- patients with serious mental illness
- pregnant or breastfeeding women
- patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiang Zhang, +8618560089182, xiang.zhang02@hotmail.com
About this study
Official title: A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma
- Conditions
- Rectal Cancer, Anastomotic Leak
- Being tested
- removal of transanal drainage tube
- 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.
removal of transanal drainage tubeDevice
removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory
| Study group | Role | What they receive |
|---|---|---|
| patients with TDT removal guided by postoperative CRP trajectory | Experimental | Not described Receives: Device: removal of transanal drainage tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic rate
anastomotic rate
Measured: 30 days after surgery
Secondary outcomes (4)
the grades of anastomotic leak
The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer
Measured: 30 days after surgery
rates of diarrhea after transanal drainage tube removal
rates of diarrhea after transanal drainage tube removal
Measured: from transanal drainage tube removal to 30 days after surgery
visual analogue scale to assess anal postoperative pain
visual analogue scale of the included patients to assess the transanal drainage tube tolerability. Visual analogue scale ranges from 0-10. 0 indicates perfectly tolerated while 10 indicates complete intolerant and the tube has to be removed.
Measured: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
transanal drainage tube-related adverse events
transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations
Measured: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
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.
- More trials run by Qilu Hospital of Shandong 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG ZHANG, Qilu Hospital of Shandong University
- Investigators
- Kexin Wang, M.D. Ph.D., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502354
- Sponsor's protocol ID
- CRC-2022-01
- Status last verified
- Nov 2023
- First submitted
- 11 Aug 2022
- Last updated
- 21 Nov 2023
- 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 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT05502354
- Acronym / sponsor ID
- CRC-2022-01
- Conditions
- Rectal Cancer, Anastomotic Leak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 16 Aug 2022 (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.
Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with TDT removal guided by postoperative CRP trajectory | Experimental | Device: removal of transanal drainage tube |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age from 18 to 75 years old
- male and female
- primary rectal adenocarcinoma
- ASA I, II, or III
- laparoscopic LAR + DST
Key exclusion criteria (8 listed)
- emergency operation
- preoperative abnormal liver function
- tatme or ISR procedure (healing process might differ from anterior resection)
- severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
- severe perioperative infection unrelated to anastomotic leak
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 |
|---|---|---|
| removal of transanal drainage tuberemoval of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory | Device | patients with TDT removal guided by postoperative CRP trajectory |
Primary outcome
anastomotic rate
Time frame: 30 days after surgery
anastomotic rate
4 secondary outcomes
the grades of anastomotic leak
Time frame: 30 days after surgery
rates of diarrhea after transanal drainage tube removal
Time frame: from transanal drainage tube removal to 30 days after surgery
visual analogue scale to assess anal postoperative pain
Time frame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
transanal drainage tube-related adverse events
Time frame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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.
Kexin Wang, M.D. Ph.D. study director
Qilu Hospital of Shandong 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 removal of transanal drainage tube in people with Rectal Cancer and Anastomotic Leak, run by Qilu Hospital of Shandong University 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 10 inclusion and 8 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 21 Nov 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 Xiang Zhang, M.D. Ph.D. (+8618560089182, xiang.zhang02@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic rate (time frame: 30 days after surgery). 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 21 Nov 2023.