TMERELOADNCT07463261
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
A study testing Without a preventive stoma and With a preventive stoma in people with TME and Rectal Cancer Surgery, run by ANO Scientific and Practical Club for the Development of Modern Medical Technologies at 7 sites in Russia.
Trial summary
The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- TME, Rectal Cancer Surgery, Low Rectal Cancer
- What is being tested?
- Without a preventive stoma and With a preventive stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 7 sitesRussia
- Study dates
- 5 May 2026to 10 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);
- Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
- Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
- Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis;
- Adequate hematologic function: hemoglobin ≥100 g/L, leukocytes >4 × 10^9/L, platelets >100 × 10^9/L;
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- Adequate renal function: serum creatinine <150 µmol/L;
- Adequate hepatic function: AST/ALT <100 U/L;
- Predicted risk of anastomotic leakage ≤10% (AFOR 0-1).
Who cannot join
- Age ≥80 years;
- Presence of a pre-existing diverting ileostomy or colostomy;
- Peritumoral abscess or tumor perforation;
- Distant metastases (M1) identified preoperatively and/or intraoperatively;
- Synchronous or metachronous malignancy;
- Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);
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- Evidence of malnutrition (serum albumin <34 g/L);
- Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric/neurological disorders impairing the ability to provide informed consent;
- Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and/or intraoperatively;
- Predicted risk of anastomotic leakage >10% (AFOR 2-6).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Russia7 sites, 7 recruiting
- Recruiting
Moscow City Oncology Hospital No. 62 of the Moscow Department of Health
Moscow, 143423
Ilya Chernikovsky, +79216576756, odindra@mail.ru
- Recruiting
Central Clinical Hospital of the Administrative Directorate of the President of the Russian Federation
Moscow
Artem Goncharov, +79990112121, goncharovartemleo@gmail.com
- Recruiting
State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow"
Moscow
Vischeslav Aliev, +79990112121, afandiali76@gmail.com
- Recruiting
State Autonomous Healthcare Institution of Nizhny Novgorod Region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncology Dispensary""
Nizhny Novgorod
Gleb Khrykov, +79990112121, ghrykov@mail.ru
- Recruiting
Leningrad Regional Clinical Hospital
Saint Petersburg
Alexey Smirnov, +79990112121, oncsmirnov@yandex.ru
- Recruiting
Republican clinical oncological center
Ufa
Rustem Ayupov, +79990112121, ru2003@bk.ru
- Recruiting
Sverdlovsk Regional Oncological Center
Yekaterinburg
Nikolay Makhotin, +79990112121, n.v.mahotin@mail.ru
About this study
Official title: Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial
The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.
The primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.
Read more
The secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.
Participants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage <10% according to the study risk model.
Read the detailed description
This study is a multicenter randomized controlled non-inferiority trial evaluating the safety of omitting routine diverting stoma formation in low-risk patients undergoing total mesorectal excision (TME) for mid- and low-rectal cancer.
Patients with a predicted risk of colorectal anastomotic leakage (AL) ≤10% will be enrolled across 7 accredited centers. Local Ethics Committee approval has been obtained at each site. The protocol follows the SPIRIT 2025 recommendations.
After informed consent, patients will be randomized 1:1 to "with preventive stoma" and "without preventive stoma". Stratified block randomization (block sizes 2, 4, or 6) will be used, stratified by center and sex. Allocation will be computer-generated (R software). No blinding will be performed. Cross-over to stoma formation in the no-stoma group is permitted in case of intraoperative safety concerns.
All patients will undergo minimally invasive TME according to oncological principles (sharp dissection within embryological planes, adequate vascular control, stapled tension-free colorectal anastomosis).
In the stoma group, a diverting ileostomy or colostomy will be created. Closure is planned ≥2-3 months postoperatively if clinically appropriate.
Postoperative care follows institutional standards. Complications will be graded according to the Clavien-Dindo classification. Patients will be followed for 1 year with clinical visits (or telephone follow-up) at 30 days and every 3 months. Imaging and colonoscopy will be performed according to clinical guidelines. Quality-of-life assessments and LARS score will be obtained at 30 days and 1 year.
Risk Prediction Model. To include the patient in the study, the risk of anastomotic leaks will be assessed on the AFOR scale. If the value is 0-1 (6-10%), the patient will be invited to participate.
Sample Size and Statistical Analysis. Assuming a baseline AL rate of 15% in the stoma group, a non-inferiority margin of 10%, one-sided α=2.5%, 80% power, and 10% dropout rate, 442 patients (221 per group) are required. The primary analysis will follow the intention-to-treat (ITT) principle. A binomial logistic regression model will estimate risk difference with 95% confidence intervals using clustered robust standard errors by center. Non-inferiority will be concluded if the upper bound of the confidence interval does not cross the predefined margin. Sensitivity analyses will include per-protocol and instrumental variable approaches. Missing data for secondary outcomes will be handled using multiple imputation (MCAR assumption).
Interim Safety Analysis. A safety analysis will be conducted after enrollment of 50 patients per group. If unacceptable differences in AL rates are observed, early termination may be considered.
- Conditions
- TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer, Local Advanced Rectal Cancer
- Being tested
- Without a preventive stoma, With a preventive stoma
- Keywords
- rectal cancer, preventive stoma, randomized trial, low-risk patients, anastomotic leak
- 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.
Without a preventive stomaProcedure or surgery
At the conclusion of total mesorectal excision (TME), a diverting ileostomy or transverse colostomy will be created at the discretion of the operating surgeon. The pelvic peritoneum over the anastomotic site will be closed, and a pelvic drain will be placed (the type of drain will be determined by the operating surgeon).
With a preventive stomaProcedure or surgery
The operating surgeon will follow the standard practice adopted at the respective center and will create either a diverting ileostomy or transverse colostomy at their discretion. The pelvic peritoneum will not be closed. Placement of a percutaneous pelvic drain adjacent to the anastomotic site is mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Without a preventive stoma | Experimental | In the no-stoma group, a diverting stoma will not be created provided there are no intraoperative complications and surgical safety principles are maintained.
If intraoperative findings suggest a high risk of anastomotic leakage such as a positive air leak test of the colorectal anastomosis, bowel perforation, use of three or more linear stapler cartridges, blood loss >300 mL, impaired bowel wall perfusion, or tension at the anastomotic site and/or if patient safety is deemed at risk, a diverting stoma may be created at the surgeon's discretion (cross-over). Receives: Procedure: Without a preventive stoma |
| With a preventive stoma | Active comparator | In the stoma group, a diverting ileostomy or colostomy will be created at the end of the surgical procedure in the right or left lateral abdominal wall, according to the technique routinely used at each participating center. Stoma closure will be planned according to standard practice (no earlier than 2-3 months after surgery), provided there are no contraindications. Receives: Procedure: With a preventive stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal anastomotic leak
If anastomotic leakage is suspected in the postoperative period defined by worsening abdominal pain (>5-point increase on the Visual Analog Scale), signs of peritonitis, drain output containing fibrin or intestinal content, or radiologic findings suggestive of leakage on contrast-enhanced CT of the abdomen and pelvis (with or without proctography) and/or findings at diagnostic laparoscopy. Diagnostic and/or therapeutic measures will be undertaken to confirm or rule out the complication.
Measured: 30 days after main surgery
Secondary outcomes (8)
Postoperative complications
Postoperative complications will be classified according to the Clavien-Dindo classification
Measured: 30 days after main surgery
Reoperation rate
During a clinic visit or by telephone interview
Measured: 30 days and 1 year after main surgery
Stoma rate
During a clinic visit or by telephone interview
Measured: 1 year after main surgery
Hospital readmissions
The frequency of repeated admissions to this or other hospitals after the patient's discharge
Measured: 30 days after main surgery
Quality of life by European Organization for Research and Treatment of Cancer-Cancer30 (EORTC-C30)
EORTC-C30 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 30 days and 1 year after surgery
Quality of life by European Organization for Research and Treatment of Cancer-ColoRectal 29 (EORTC-CR29)
EORTC-CR29 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 30 days and 1 year after surgery
Low Anterior Resection Syndrome (LARS)
At 1 year, assessment of Low Anterior Resection Syndrome (LARS) will be performed during a clinic visit or by telephone interview.
Measured: 1 year after main surgery
Length of hospital stay
total days in hospital
Measured: until discharge within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start5 May 2026
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMEStudies 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
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goncharova Vladislava Sergeevna, ANO Scientific and Practical Club for the Development of Modern Medical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463261
- Sponsor's protocol ID
- 07/25
- Acronym
- RELOAD
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07463261
- Acronym / sponsor ID
- RELOAD / 07/25
- Conditions
- TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer, Local Advanced Rectal Cancer
- Keywords
- rectal cancer, preventive stoma, randomized trial, low-risk patients, anastomotic leak
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical TechnologiesUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 11 Mar 2026 (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 purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.
The primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.
The secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.
Participants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage <10% according to the study risk model.
Detailed description
This study is a multicenter randomized controlled non-inferiority trial evaluating the safety of omitting routine diverting stoma formation in low-risk patients undergoing total mesorectal excision (TME) for mid- and low-rectal cancer.
Patients with a predicted risk of colorectal anastomotic leakage (AL) ≤10% will be enrolled across 7 accredited centers. Local Ethics Committee approval has been obtained at each site. The protocol follows the SPIRIT 2025 recommendations.
After informed consent, patients will be randomized 1:1 to "with preventive stoma" and "without preventive stoma". Stratified block randomization (block sizes 2, 4, or 6) will be used, stratified by center and sex. Allocation will be computer-generated (R software). No blinding will be performed. Cross-over to stoma formation in the no-stoma group is permitted in case of intraoperative safety concerns.
All patients will undergo minimally invasive TME according to oncological principles (sharp dissection within embryological planes, adequate vascular control, stapled tension-free colorectal anastomosis).
In the stoma group, a diverting ileostomy or colostomy will be created. Closure is planned ≥2-3 months postoperatively if clinically appropriate.
Postoperative care follows institutional standards. Complications will be graded according to the Clavien-Dindo classification. Patients will be followed for 1 year with clinical visits (or telephone follow-up) at 30 days and every 3 months. Imaging and colonoscopy will be performed according to clinical guidelines. Quality-of-life assessments and LARS score will be obtained at 30 days and 1 year.
Risk Prediction Model. To include the patient in the study, the risk of anastomotic leaks will be assessed on the AFOR scale. If the value is 0-1 (6-10%), the patient will be invited to participate.
Sample Size and Statistical Analysis. Assuming a baseline AL rate of 15% in the stoma group, a non-inferiority margin of 10%, one-sided α=2.5%, 80% power, and 10% dropout rate, 442 patients (221 per group) are required. The primary analysis will follow the intention-to-treat (ITT) principle. A binomial logistic regression model will estimate risk difference with 95% confidence intervals using clustered robust standard errors by center. Non-inferiority will be concluded if the upper bound of the confidence interval does not cross the predefined margin. Sensitivity analyses will include per-protocol and instrumental variable approaches. Missing data for secondary outcomes will be handled using multiple imputation (MCAR assumption).
Interim Safety Analysis. A safety analysis will be conducted after enrollment of 50 patients per group. If unacceptable differences in AL rates are observed, early termination may be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without a preventive stoma | Experimental | Procedure: Without a preventive stomaIn the no-stoma group, a diverting stoma will not be created provided there are no intraoperative complications and surgical safety principles are maintained. If intraoperative findings suggest a high risk of anastomotic leakage such as a positive air leak test of the colorectal anastomosis, bowel perforation, use of three or more linear stapler cartridges, blood loss >300 mL, impaired bowel wall perfusion, or tension at the anastomotic site and/or if patient safety is deemed at risk, a diverting stoma may be created at the surgeon's discretion (cross-over). |
| With a preventive stoma | Active comparator | Procedure: With a preventive stomaIn the stoma group, a diverting ileostomy or colostomy will be created at the end of the surgical procedure in the right or left lateral abdominal wall, according to the technique routinely used at each participating center. Stoma closure will be planned according to standard practice (no earlier than 2-3 months after surgery), provided there are no contraindications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years;
- Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);
- Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;
- Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and/or pelvic MRI);
- Planned radical minimally invasive (laparoscopic/robot-assisted) intervention with TME and formation of primary colorectal/colonanal anastomosis;
Key exclusion criteria (10 listed)
- Age ≥80 years;
- Presence of a pre-existing diverting ileostomy or colostomy;
- Peritumoral abscess or tumor perforation;
- Distant metastases (M1) identified preoperatively and/or intraoperatively;
- Synchronous or metachronous malignancy;
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 |
|---|---|---|
| Without a preventive stomaAt the conclusion of total mesorectal excision (TME), a diverting ileostomy or transverse colostomy will be created at the discretion of the operating surgeon. The pelvic peritoneum over the anastomotic site will be closed, and a pelvic drain will be placed (the type of drain will be determined by the operating surgeon). | Procedure or surgery | Without a preventive stoma |
| With a preventive stomaThe operating surgeon will follow the standard practice adopted at the respective center and will create either a diverting ileostomy or transverse colostomy at their discretion. The pelvic peritoneum will not be closed. Placement of a percutaneous pelvic drain adjacent to the anastomotic site is mandatory. | Procedure or surgery | With a preventive stoma |
Primary outcome
Colorectal anastomotic leak
Time frame: 30 days after main surgery
If anastomotic leakage is suspected in the postoperative period defined by worsening abdominal pain (>5-point increase on the Visual Analog Scale), signs of peritonitis, drain output containing fibrin or intestinal content, or radiologic findings suggestive of leakage on contrast-enhanced CT of the abdomen and pelvis (with or without proctography) and/or findings at diagnostic laparoscopy. Diagnostic and/or therapeutic measures will be undertaken to confirm or rule out the complication.
8 secondary outcomes
Postoperative complications
Time frame: 30 days after main surgery
Reoperation rate
Time frame: 30 days and 1 year after main surgery
Stoma rate
Time frame: 1 year after main surgery
Hospital readmissions
Time frame: 30 days after main surgery
Quality of life by European Organization for Research and Treatment of Cancer-Cancer30 (EORTC-C30)
Time frame: 30 days and 1 year after surgery
Quality of life by European Organization for Research and Treatment of Cancer-ColoRectal 29 (EORTC-CR29)
Time frame: 30 days and 1 year after surgery
Low Anterior Resection Syndrome (LARS)
Time frame: 1 year after main surgery
Length of hospital stay
Time frame: until discharge within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without a preventive stoma and With a preventive stoma in people with TME and Rectal Cancer Surgery, run by ANO Scientific and Practical Club for the Development of Modern Medical Technologies at 7 sites in Russia.
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 10 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladislava S Goncharova, Ms. (+7 900 468 9026, vladislava.26@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal anastomotic leak (time frame: 30 days after main 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 13 May 2026.