Rectal NeoplasmsLIVELOCNCT05745909
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
A study testing Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy and Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy in people with Rectal Neoplasms and Ostomy, run by Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan at 1 site in Russia.
Trial summary
The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Rectal Neoplasms, Ostomy, Neoplasms
- What is being tested?
- Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy and Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2023to 30 Jul 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
- ECOG status 0-2,
- ASA≤3.
- At least 18 years of age
- Written informed consent
Who cannot join
- Emergency surgery;
- Previously formed stoma;
- Stage 4 disease;
- Obstructive resection of the rectum;
- Patients older than 79 years
Trial locations and contacts
1 site in 1 country.
Russia1 site
Republican clinical oncological dispencery
Ufa, Bashkortostan Republic, 450054
About this study
Official title: Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections
The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.
Read the detailed description
The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024.
All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery.
The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130.
The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.
- Conditions
- Rectal Neoplasms, Ostomy, Neoplasms
- Being tested
- Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy, Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy
- Keywords
- Rectal cancer, Low anterior resection, Loop transverse colostomy, Loop ileostomy, Stoma site infections
- Medical subject headings
- Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomyProcedure or surgery
The loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.
Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomyProcedure or surgery
The loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.
| Study group | Role | What they receive |
|---|---|---|
| Loop transverse colostomy | Active comparator | Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy Receives: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy |
| Loop ileostomy | Experimental | Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy Receives: Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI
incidence of stoma site infections
Measured: 60 days after surgery
Ileus
incidence of stoma dysfunction
Measured: 60 days after surgery
Secondary outcomes (6)
Readmission rate
readmission rate
Measured: within the first 60 days after surgery
Length of hospital stay
the number of days from surgery to discharge
Measured: From date of surgery until the date of discharge, assessed up to 60 days
Time to stoma closure
the number of days from surgery to stoma closure
Measured: within the first 6 months days after surgery
Time to first stool
the occurrence of anything other than serous-hemorrhagic contents in the colostomy bag
Measured: 60 days after surgery
Time to adjuvant postoperative chemotherapy
the number of days from surgery to hospitalization for first chemotherapy
Measured: within the first 2 months days after surgery
Quality of life in patients with ostomy
estimated using EORTC QLQ-CR29
Measured: within the first 60 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 posted27 Feb 2023
- Study start1 Mar 2023
- Primary completion31 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksim Popov, Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745909
- Sponsor's protocol ID
- IK-001
- Acronym
- LIVELOC
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Center Clinical Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy in Patients After Major Anterior Resections
- ClinicalTrials.gov ID
- NCT05745909
- Acronym / sponsor ID
- LIVELOC / IK-001
- Conditions
- Rectal Neoplasms, Ostomy, Neoplasms
- Keywords
- Rectal cancer, Low anterior resection, Loop transverse colostomy, Loop ileostomy, Stoma site infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of BashkortostanUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 27 Feb 2023 (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 study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.
Detailed description
The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024.
All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery.
The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130.
The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loop transverse colostomy | Active comparator | Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomyLaparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy |
| Loop ileostomy | Experimental | Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomyLaparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
- ECOG status 0-2,
- ASA≤3.
- At least 18 years of age
- Written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery;
- Previously formed stoma;
- Stage 4 disease;
- Obstructive resection of the rectum;
- Patients older than 79 years
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 |
|---|---|---|
| Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomyThe loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border. | Procedure or surgery | Loop transverse colostomy |
| Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomyThe loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border. | Procedure or surgery | Loop ileostomy |
Primary outcome
SSI
Time frame: 60 days after surgery
incidence of stoma site infections
Ileus
Time frame: 60 days after surgery
incidence of stoma dysfunction
6 secondary outcomes
Readmission rate
Time frame: within the first 60 days after surgery
Length of hospital stay
Time frame: From date of surgery until the date of discharge, assessed up to 60 days
Time to stoma closure
Time frame: within the first 6 months days after surgery
Time to first stool
Time frame: 60 days after surgery
Time to adjuvant postoperative chemotherapy
Time frame: within the first 2 months days after surgery
Quality of life in patients with ostomy
Time frame: within the first 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy and Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy in people with Rectal Neoplasms and Ostomy, run by Republican Clinical Oncological Dispensary, Ministry of Health of the Republic of Bashkortostan at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI (time frame: 60 days after surgery). The study lists 2 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 19 Sep 2024.