Bowel SoundsBRIEFNCT07705139
The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients
An observational study of Bowel Sounds and Colorectal Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study enrolls patients scheduled to undergo curative surgery for colorectal cancer. Bowel sounds will be assessed preoperatively and postoperatively. By comparing intraoperative variables, the incidence of perioperative complications, reoperation rates, and postoperative outcomes-including time to first flatus… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bowel Sounds, Colorectal Cancer, Intestinal Obstruction
- What is being tested?
- colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 28 Jul 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolls patients scheduled to undergo curative surgery for colorectal cancer.
Who may be able to join
- Aged 18-80 years.
- Histopathologically confirmed colorectal adenocarcinoma according to the WHO 2022 classification.
- No restriction on prior neoadjuvant or other antitumor therapies, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- Able to understand the study requirements and voluntarily provide written informed consent (patient and/or legally authorized representative).
- Able to communicate effectively with the investigators and willing to comply with all study procedures, including postoperative management and follow-up.
Who cannot join
- Significant organ dysfunction indicating inability to tolerate surgery or an unacceptably high perioperative risk, including:
- Severe cardiac dysfunction (NYHA Class III or IV).
- Severe hepatic dysfunction (MELD score >12).
- Severe renal dysfunction (eGFR <30 mL/min/1.73 m² [CKD stage 4-5] or end-stage renal disease requiring dialysis).
- Severe pulmonary dysfunction (resting PaO₂ <60 mmHg on room air or respiratory failure requiring long-term oxygen therapy or mechanical ventilation).
- Participation in another clinical study within 4 weeks before enrollment or concurrent participation in another interventional clinical study.
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- Emergency surgery required because of intestinal obstruction, perforation, or other acute abdominal conditions.
- Severe psychiatric disorders that would interfere with compliance with perioperative management or follow-up.
- Pregnant or breastfeeding women.
- Any other clinical or laboratory abnormality that, in the opinion of the investigator, would make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
siyuan Yin, Master, +8618771708286, 2023283030136@whu.edu.cn
About this study
Official title: The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients: A Prospective Cohort Study
This study enrolls patients scheduled to undergo curative surgery for colorectal cancer. Bowel sounds will be assessed preoperatively and postoperatively. By comparing intraoperative variables, the incidence of perioperative complications, reoperation rates, and postoperative outcomes-including time to first flatus, resumption of oral intake, and occurrence of intestinal obstruction-this study aims to investigate the association between perioperative bowel sounds and postoperative recovery, and provide evidence-based support for the clinical application of bowel sound monitoring.
Supplementary Definitions
Read the detailed description
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, both the incidence and mortality of colorectal cancer in China have shown a significant upward trend. With population aging and lifestyle changes, the disease is increasingly affecting younger individuals, with the proportion of patients under 40 years of age steadily rising. Treatment strategies vary according to disease stage; however, for most cases amenable to primary resection, surgical intervention remains the cornerstone of therapy.
With the widespread implementation of Enhanced Recovery After Surgery (ERAS) protocols, postoperative rehabilitation has been substantially improved through optimization of preoperative, intraoperative, and postoperative management strategies, such as shortened preoperative fasting, the use of laparoscopic techniques, and early postoperative oral intake, thereby facilitating accelerated recovery and earlier discharge. Following curative surgery for colorectal cancer, patients commonly experience reduced or transiently absent intestinal motility due to surgical manipulation and the effects of anesthesia, with gradual return to normal function over several days. Early postoperative feeding has been shown to promote gastrointestinal functional recovery.
However, a subset of patients may exhibit delayed recovery of bowel function, characterized by diminished bowel sound activity, prolonged time to first flatus, and often accompanied by abdominal distension. Postoperative ileus (POI) is one of the most common causes of delayed postoperative gastrointestinal recovery and typically presents as transient suppression of gastrointestinal motility. When the duration exceeds the expected physiological range, potential pathological conditions, such as early postoperative small bowel obstruction (EPSBO), should be considered. In such circumstances, oral intake may exacerbate the ileus and even precipitate intestinal obstruction. Therefore, timely differentiation and accurate diagnosis of the patient's postoperative gastrointestinal status are of critical importance.
Abdominal auscultation, as a noninvasive diagnostic technique, has a history spanning several centuries. In 1905, Cannon was the first to report systematic investigations of abdominal auscultation, proposing that regular bowel sounds are generated by intestinal peristaltic activity. Subsequent studies have demonstrated that bowel sounds vary by anatomical location: sounds originating from the small intestine are typically high-pitched, high-amplitude, and frequent, whereas colonic sounds are lower in frequency, weaker in amplitude, and less frequent. Postoperatively, the recovery of gastrointestinal motility differs among intestinal segments, with the small intestine recovering first, followed by the stomach and the colon.
Abdominal auscultation has been widely used as an adjunctive tool in the evaluation of conditions such as intestinal obstruction and ileus owing to its immediacy and convenience and is commonly applied in patients with delayed postoperative gastrointestinal recovery. However, the reliability of auscultation-based assessment remains controversial because of the inherent subjectivity in clinicians' descriptions of bowel sounds. A prospective study by Felder et al. demonstrated a low sensitivity of 22%-32% for manual auscultation in distinguishing healthy from diseased individuals, along with low positive predictive values of 23%-44%. Similarly, Thomas et al. conducted a prospective study examining the relationship between auscultated bowel sounds and postoperative oral tolerance and flatus, finding no significant correlation between bowel sounds and postoperative abdominal distension, flatus, defecation, or tolerance of oral intake.
Therefore, digital bowel sound monitoring devices, which objectively detect and analyze bowel sounds, have emerged as important adjunctive tools for postoperative bowel sound assessment. These systems enable precise quantification of acoustic features such as frequency, amplitude, and energy. Currently, both domestic and international researchers have begun to explore the use of bowel sound monitoring systems in the diagnosis and management of gastrointestinal disorders. Preliminary small-sample studies suggest that such systems hold substantial clinical potential in the precision management of intestinal obstruction, the diagnosis of functional gastrointestinal disorders, and the prediction of acute gastrointestinal injury in critically ill patients.
Nevertheless, progress in bowel sound monitoring technology has been relatively slow, primarily because of several challenges: (1) the weak and highly stochastic nature of bowel sound signals; (2) substantial interference from environmental and internal physiological noise; and (3) dynamic fluctuations in bowel sounds related to individual physiological states, with marked interindividual variability. To address these challenges, our center has independently developed a highly intelligent digital bowel sound monitoring system based on a distributed, multichannel, real-time acquisition framework. This system enables simultaneous collection of bowel sound signals from different abdominal regions while concurrently recording cardiac sounds and ambient noise as reference signals for noise suppression, followed by centralized classification and recognition of bowel sounds. Through this approach, bowel sound signals can be accurately extracted in complex acoustic environments, significantly improving the accuracy of feature detection, parameter computation, and classification algorithms while also assisting clinicians with synchronized auscultation.
At present, our center has conducted multiple iterations of the bowel sound monitoring device, completing optimized denoising and detection algorithms that enable accurate extraction of bowel sound signals in complex environments. Furthermore, we have implemented a bowel sound recognition algorithm that integrates an attention-based Broadcasting Residual Neural Network (Broadcasting ResNet) with a Dual-Path Recurrent Neural Network (Dual-Path RNN). This algorithm is capable of extracting time-frequency features of bowel sounds, thereby supporting the auxiliary diagnosis of various intestinal disorders.
In summary, there is an urgent need for a high-quality, prospective clinical trial to investigate the predictive value of digital bowel sound monitoring for postoperative gastrointestinal functional recovery. Such a study would facilitate the clinical translation of this technology and assist clinicians in the diagnosis and early intervention of postoperative intestinal dysfunction.
- Conditions
- Bowel Sounds, Colorectal Cancer, Intestinal Obstruction, Postoperative Ileus, Colorectal Surgery
- Being tested
- colorectal surgery
- Keywords
- bowel sounds, Colorectal Cancer, Intestinal Obstruction, Postoperative Ileus, Colorectal Surgery
- Medical subject headings
- Colorectal Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal surgeryProcedure or surgery
Based on the preoperative multidisciplinary team (MDT) discussion, the appropriate surgical procedure was selected, including right hemicolectomy, left hemicolectomy, or radical resection for rectal cancer, as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| normal group | No intestinal obstruction occurred during the perioperative period. Receives: Procedure: colorectal surgery | |
| POI group | Intestinal obstruction occurred during the perioperative period. Receives: Procedure: colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative ileus ( POI) after surgery.
Measured: From surgery through postoperative day 30
Secondary outcomes (6)
Postoperative Complications within 30 Days
Incidence of complications such as anastomotic leak/dehiscence, anastomotic bleeding, ischemic bowel necrosis, intra-abdominal infection, intra-abdominal hemorrhage, early postoperative intestinal obstruction, postoperative ileus, pulmonary infection, and other complications, as well as reoperations resulting from these events. The severity of complications will be graded using the Classification of Surgical Complications.
Measured: From surgery through postoperative day 30
Length of postoperative hospital stay
Length of postoperative hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge. A longer hospital stay indicates delayed postoperative recovery or the occurrence of postoperative complications.
Measured: From surgery through postoperative day 30
Time to first flatus
Time to first flatus, defined as the time (in hours) from the completion of surgery to the patient's first reported passage of flatus.
Measured: From surgery through postoperative day 30
Time to first defecation
Time to first defecation, defined as the time (in hours) from the completion of surgery to the patient's first bowel movement
Measured: From surgery through postoperative day 30
Total hospitalization cost (before reimbursement)
Total hospitalization cost before reimbursement, defined as the total medical expenses incurred during the index hospitalization prior to any insurance reimbursement or financial assistance, as recorded in the hospital billing system.
Measured: From surgery through postoperative day 30
Bowel Sound Characteristics
Five-minute bowel sound recordings obtained at 2 h, 6 h, 12 h, 24 h, 36 h, 48 h, 60 h, 72 h, 84 h, and 96 h postoperatively, with corresponding acoustic feature analyses.
Measured: From surgery through postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Feb 2026
- Primary completion15 May 2026
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University
- Responsible party
- Sponsor
- Investigators
- Congqing Jiang, professor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705139
- Sponsor's protocol ID
- ZNH-2025-BA-02
- Acronym
- BRIEF
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07705139
- Acronym / sponsor ID
- BRIEF / ZNH-2025-BA-02
- Conditions
- Bowel Sounds, Colorectal Cancer, Intestinal Obstruction, Postoperative Ileus, Colorectal Surgery
- Keywords
- bowel sounds, Colorectal Cancer, Intestinal Obstruction, Postoperative Ileus, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Wuhan University
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 15 Jul 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.
This study enrolls patients scheduled to undergo curative surgery for colorectal cancer. Bowel sounds will be assessed preoperatively and postoperatively. By comparing intraoperative variables, the incidence of perioperative complications, reoperation rates, and postoperative outcomes-including time to first flatus, resumption of oral intake, and occurrence of intestinal obstruction-this study aims to investigate the association between perioperative bowel sounds and postoperative recovery, and provide evidence-based support for the clinical application of bowel sound monitoring.
Supplementary Definitions
Detailed description
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, both the incidence and mortality of colorectal cancer in China have shown a significant upward trend. With population aging and lifestyle changes, the disease is increasingly affecting younger individuals, with the proportion of patients under 40 years of age steadily rising. Treatment strategies vary according to disease stage; however, for most cases amenable to primary resection, surgical intervention remains the cornerstone of therapy.
With the widespread implementation of Enhanced Recovery After Surgery (ERAS) protocols, postoperative rehabilitation has been substantially improved through optimization of preoperative, intraoperative, and postoperative management strategies, such as shortened preoperative fasting, the use of laparoscopic techniques, and early postoperative oral intake, thereby facilitating accelerated recovery and earlier discharge. Following curative surgery for colorectal cancer, patients commonly experience reduced or transiently absent intestinal motility due to surgical manipulation and the effects of anesthesia, with gradual return to normal function over several days. Early postoperative feeding has been shown to promote gastrointestinal functional recovery.
However, a subset of patients may exhibit delayed recovery of bowel function, characterized by diminished bowel sound activity, prolonged time to first flatus, and often accompanied by abdominal distension. Postoperative ileus (POI) is one of the most common causes of delayed postoperative gastrointestinal recovery and typically presents as transient suppression of gastrointestinal motility. When the duration exceeds the expected physiological range, potential pathological conditions, such as early postoperative small bowel obstruction (EPSBO), should be considered. In such circumstances, oral intake may exacerbate the ileus and even precipitate intestinal obstruction. Therefore, timely differentiation and accurate diagnosis of the patient's postoperative gastrointestinal status are of critical importance.
Abdominal auscultation, as a noninvasive diagnostic technique, has a history spanning several centuries. In 1905, Cannon was the first to report systematic investigations of abdominal auscultation, proposing that regular bowel sounds are generated by intestinal peristaltic activity. Subsequent studies have demonstrated that bowel sounds vary by anatomical location: sounds originating from the small intestine are typically high-pitched, high-amplitude, and frequent, whereas colonic sounds are lower in frequency, weaker in amplitude, and less frequent. Postoperatively, the recovery of gastrointestinal motility differs among intestinal segments, with the small intestine recovering first, followed by the stomach and the colon.
Abdominal auscultation has been widely used as an adjunctive tool in the evaluation of conditions such as intestinal obstruction and ileus owing to its immediacy and convenience and is commonly applied in patients with delayed postoperative gastrointestinal recovery. However, the reliability of auscultation-based assessment remains controversial because of the inherent subjectivity in clinicians' descriptions of bowel sounds. A prospective study by Felder et al. demonstrated a low sensitivity of 22%-32% for manual auscultation in distinguishing healthy from diseased individuals, along with low positive predictive values of 23%-44%. Similarly, Thomas et al. conducted a prospective study examining the relationship between auscultated bowel sounds and postoperative oral tolerance and flatus, finding no significant correlation between bowel sounds and postoperative abdominal distension, flatus, defecation, or tolerance of oral intake.
Therefore, digital bowel sound monitoring devices, which objectively detect and analyze bowel sounds, have emerged as important adjunctive tools for postoperative bowel sound assessment. These systems enable precise quantification of acoustic features such as frequency, amplitude, and energy. Currently, both domestic and international researchers have begun to explore the use of bowel sound monitoring systems in the diagnosis and management of gastrointestinal disorders. Preliminary small-sample studies suggest that such systems hold substantial clinical potential in the precision management of intestinal obstruction, the diagnosis of functional gastrointestinal disorders, and the prediction of acute gastrointestinal injury in critically ill patients.
Nevertheless, progress in bowel sound monitoring technology has been relatively slow, primarily because of several challenges: (1) the weak and highly stochastic nature of bowel sound signals; (2) substantial interference from environmental and internal physiological noise; and (3) dynamic fluctuations in bowel sounds related to individual physiological states, with marked interindividual variability. To address these challenges, our center has independently developed a highly intelligent digital bowel sound monitoring system based on a distributed, multichannel, real-time acquisition framework. This system enables simultaneous collection of bowel sound signals from different abdominal regions while concurrently recording cardiac sounds and ambient noise as reference signals for noise suppression, followed by centralized classification and recognition of bowel sounds. Through this approach, bowel sound signals can be accurately extracted in complex acoustic environments, significantly improving the accuracy of feature detection, parameter computation, and classification algorithms while also assisting clinicians with synchronized auscultation.
At present, our center has conducted multiple iterations of the bowel sound monitoring device, completing optimized denoising and detection algorithms that enable accurate extraction of bowel sound signals in complex environments. Furthermore, we have implemented a bowel sound recognition algorithm that integrates an attention-based Broadcasting Residual Neural Network (Broadcasting ResNet) with a Dual-Path Recurrent Neural Network (Dual-Path RNN). This algorithm is capable of extracting time-frequency features of bowel sounds, thereby supporting the auxiliary diagnosis of various intestinal disorders.
In summary, there is an urgent need for a high-quality, prospective clinical trial to investigate the predictive value of digital bowel sound monitoring for postoperative gastrointestinal functional recovery. Such a study would facilitate the clinical translation of this technology and assist clinicians in the diagnosis and early intervention of postoperative intestinal dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Procedure: colorectal surgeryNo intestinal obstruction occurred during the perioperative period. |
| POI group | – | Procedure: colorectal surgeryIntestinal obstruction occurred during the perioperative period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls patients scheduled to undergo curative surgery for colorectal cancer.
Key inclusion criteria (5 listed)
- Aged 18-80 years.
- Histopathologically confirmed colorectal adenocarcinoma according to the WHO 2022 classification.
- No restriction on prior neoadjuvant or other antitumor therapies, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- Able to understand the study requirements and voluntarily provide written informed consent (patient and/or legally authorized representative).
- Able to communicate effectively with the investigators and willing to comply with all study procedures, including postoperative management and follow-up.
Key exclusion criteria (10 listed)
- Significant organ dysfunction indicating inability to tolerate surgery or an unacceptably high perioperative risk, including:
- Severe cardiac dysfunction (NYHA Class III or IV).
- Severe hepatic dysfunction (MELD score >12).
- Severe renal dysfunction (eGFR <30 mL/min/1.73 m² [CKD stage 4-5] or end-stage renal disease requiring dialysis).
- Severe pulmonary dysfunction (resting PaO₂ <60 mmHg on room air or respiratory failure requiring long-term oxygen therapy or mechanical ventilation).
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 |
|---|---|---|
| colorectal surgeryBased on the preoperative multidisciplinary team (MDT) discussion, the appropriate surgical procedure was selected, including right hemicolectomy, left hemicolectomy, or radical resection for rectal cancer, as clinically indicated. | Procedure or surgery | POI group, normal group |
Primary outcome
Occurrence of postoperative ileus ( POI) after surgery.
Time frame: From surgery through postoperative day 30
6 secondary outcomes
Postoperative Complications within 30 Days
Time frame: From surgery through postoperative day 30
Length of postoperative hospital stay
Time frame: From surgery through postoperative day 30
Time to first flatus
Time frame: From surgery through postoperative day 30
Time to first defecation
Time frame: From surgery through postoperative day 30
Total hospitalization cost (before reimbursement)
Time frame: From surgery through postoperative day 30
Bowel Sound Characteristics
Time frame: From surgery through postoperative day 30
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 15 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Congqing Jiang, professor study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Sounds and Colorectal Cancer, run by Zhongnan Hospital 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 5 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 15 Jul 2026. 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?
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 siyuan yin, master (+86 18771708286, 2023283030136@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postoperative ileus ( POI) after surgery. (time frame: From surgery through postoperative day 30). 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 15 Jul 2026.