the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant TherapyNCT05267275
Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy
A study testing extended resection with splenic flexure mobilization in people with the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
- What is being tested?
- extended resection with splenic flexure mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to Dec 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
- Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
- The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
- Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
- Aged between 18-75 years old;
- ASA rating: 0-2
- ECOG Score: 0-2
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- BMI 18-30 kg/m2;
- Radical surgical resection is expected to be possible on the basis of preserving the anus;
- Sign the informed consent document.
Who cannot join
- History of other malignant tumors;
- Emergency surgery patients;
- Severe underlying diseases, unable to tolerate surgery;
- Without informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yanlei Wang, +8618560085128, yanleiwang@hotmail.com
About this study
Official title: Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications
Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. However, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. According to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. However, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. Therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.
- Being tested
- extended resection with splenic flexure mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended resection with splenic flexure mobilizationProcedure or surgery
During the operation, the splenic flexure of the colon was first freed, and then the physiological adhesion site of the sigmoid colon was located. Routine laparoscopic or open rectal cancer radical resection (D3 dissection + high ligation) was performed. The proximal end of the colon is disconnected 10-15cm away from the physiological adhesion site of the sigmoid colon. The anastomosis method was manual anastomosis or stapler anastomosis, and a prophylactic ileal loop ostomy was routinely performed.
| Study group | Role | What they receive |
|---|---|---|
| extended resection with splenic flexure mobilization | Experimental | Not described Receives: Procedure: extended resection with splenic flexure mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of complications related to rectal anastomosis
Measured: From the end of the surgery to 1 year after ileostomy closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start30 Nov 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant TherapyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267275
- Sponsor's protocol ID
- KYLL-202111-226
- Status last verified
- Nov 2021
- First submitted
- 23 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications
- ClinicalTrials.gov ID
- NCT05267275
- Acronym / sponsor ID
- KYLL-202111-226
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Mar 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.
Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. However, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. According to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. However, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. Therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extended resection with splenic flexure mobilization | Experimental | Procedure: extended resection with splenic flexure mobilization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
- The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
- Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
- Aged between 18-75 years old;
- ASA rating: 0-2
Key exclusion criteria (4 listed)
- History of other malignant tumors;
- Emergency surgery patients;
- Severe underlying diseases, unable to tolerate surgery;
- Without informed consent.
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 |
|---|---|---|
| extended resection with splenic flexure mobilizationDuring the operation, the splenic flexure of the colon was first freed, and then the physiological adhesion site of the sigmoid colon was located. Routine laparoscopic or open rectal cancer radical resection (D3 dissection + high ligation) was performed. The proximal end of the colon is disconnected 10-15cm away from the physiological adhesion site of the sigmoid colon. The anastomosis method was manual anastomosis or stapler anastomosis, and a prophylactic ileal loop ostomy was routinely performed. | Procedure or surgery | extended resection with splenic flexure mobilization |
Primary outcome
incidence of complications related to rectal anastomosis
Time frame: From the end of the surgery to 1 year after ileostomy closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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 extended resection with splenic flexure mobilization in people with the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy, 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 9 inclusion and 4 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 4 Mar 2022. 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 Yanlei Wang (+8618560085128, yanleiwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications related to rectal anastomosis (time frame: From the end of the surgery to 1 year after ileostomy closure). 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 4 Mar 2022.