Rectal CancerSC-StomaNCT07605611
Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection
A study testing Somatostatin, Clear Liquid Diet and Prophylactic Diverting Stoma in people with Rectal Cancer and Anastomotic Leakage, run by Tongji Hospital at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Anastomotic Leakage
- What is being tested?
- Somatostatin, Clear Liquid Diet and Prophylactic Diverting Stoma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesChina
- Study dates
- 17 Nov 2025to 30 Jun 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
- The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination
- The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
- Patients have two or more risk factors for anastomotic leakage as assessed by the study team
- American Society of Anesthesiologists physical status classification is grade 3 or lower
- Body mass index is less than 30 kg/m²
- The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent
Who cannot join
- Has another colorectal malignant tumor at the same time
- The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
- Has metastatic disease before surgery
- Is pregnant
- Has a mental illness or addictive disorder that would prevent participation in the clinical trial
- Requires emergency surgery
Show all 11Show fewer
- Has inflammatory bowel disease
- Is allergic to somatostatin or is unable to tolerate somatostatin
- For participants assigned to the no-stoma group, the surgeon decides that a stoma is required
- Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery
- Has any other condition that makes it impossible to follow the study protocol
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Ezhou Central Hospital
Ezhou, Hubei
Antian Lu, +8613208585786, lat0061@163.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Antian Lu, +8613208585786, lat0061@163.com
- Not yet recruiting
Wuhan No. 6 Hospital
Wuhan, Hubei
Antian Lu, +8613208585786, lat0061@163.com
About this study
Official title: A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection
The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery.
The main questions it aims to answer are:
Read more
Does somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma?
What medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up?
Researchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation.
Participants will:
Have rectal cancer surgery with the bowel joined very close to the anus
Be randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma
Have follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life
Complete follow-up visits or assessments for up to 3 years after surgery
Read the detailed description
This is a multicenter, open-label, randomized clinical trial evaluating a postoperative no-stoma management strategy in adults with low or mid rectal cancer undergoing ultra-low anterior resection. Patients undergoing ultra-low colorectal or coloanal anastomosis are at increased risk of anastomotic leakage. A prophylactic diverting stoma is commonly used to reduce the clinical consequences of leakage, but stoma creation may also lead to stoma-related complications, delayed stoma closure, additional surgery, and impaired quality of life.
The study evaluates whether a 7-day postoperative regimen of somatostatin plus a clear liquid diet can serve as an alternative strategy to reduce intestinal contents passing through the anastomosis during the early postoperative period. Somatostatin is used to reduce gastrointestinal secretions, and a clear liquid diet is used to limit solid residue in the digestive tract. The investigational strategy is compared with prophylactic diverting stoma, which is commonly used in patients considered to be at high risk of leakage after low rectal surgery.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment strategies after ultra-low anterior resection. Participants in the experimental group will not undergo prophylactic stoma creation and will receive somatostatin plus a clear liquid diet for 7 days after surgery. Participants in the control group will undergo prophylactic diverting stoma and receive standard postoperative care. Both groups will receive routine perioperative management according to clinical practice at the participating centers.
The primary clinical focus is severe anastomotic leakage within 1 month after surgery, defined as leakage requiring reoperation. The study will also assess postoperative complications, bowel function, quality of recovery, quality of life, and longer-term functional outcomes during follow-up. Participants will be followed for up to 3 years after surgery.
This trial is intended to determine whether somatostatin plus a clear liquid diet without prophylactic stoma can provide similar protection against severe anastomotic leakage compared with prophylactic diverting stoma, while reducing the need for stoma creation and its related burden.
- Conditions
- Rectal Cancer, Anastomotic Leakage
- Being tested
- Somatostatin, Clear Liquid Diet, Prophylactic Diverting Stoma
- Keywords
- Rectal cancer, Ultra-low anterior resection, Anastomotic leakage, Severe anastomotic leakage, Diverting stoma, Prophylactic stoma, Somatostatin, Clear liquid diet, Bowel function, Quality of life
- 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.
SomatostatinDrug
Participants in the experimental arm will receive somatostatin 3 mg diluted in 50 mL of 0.9% sodium chloride by intravenous infusion pump at 4.1 mL/hour every 12 hours for 7 days after surgery, as part of the postoperative no-stoma management strategy.
Clear Liquid DietOther
Participants in the experimental arm will receive a clear liquid diet after recovery of bowel gas passage, as part of the 7-day postoperative no-stoma management strategy. Parenteral nutrition may be provided according to clinical needs.
Prophylactic Diverting StomaProcedure or surgery
Participants in the control arm will undergo prophylactic diverting stoma creation during ultra-low anterior resection and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.
| Study group | Role | What they receive |
|---|---|---|
| Somatostatin Plus Clear Liquid Diet Without Diverting Stoma | Experimental | Participants in this arm will undergo ultra-low anterior resection without prophylactic diverting stoma. After surgery, they will receive somatostatin plus a clear liquid diet for 7 days, along with routine postoperative care. Receives: Drug: Somatostatin; Other: Clear Liquid Diet |
| Prophylactic Diverting Stoma | Active comparator | Participants in this arm will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary. Receives: Procedure: Prophylactic Diverting Stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade C Anastomotic Leakage Within 1 Month After Surgery
Proportion of participants who develop grade C anastomotic leakage within 1 month after surgery. Grade C anastomotic leakage is defined as anastomotic leakage requiring reoperation.
Measured: Within 1 month after surgery
Secondary outcomes (3)
Postoperative Complication Severity Within 1 Month After Surgery
Postoperative complications will be assessed within 1 month after surgery using the Clavien-Dindo classification. The highest complication grade for each participant will be recorded, with higher grades indicating more severe postoperative complications.
Measured: Within 1 month after surgery
Low Anterior Resection Syndrome Score Within 1 Month After Surgery
Bowel dysfunction after low anterior resection will be assessed using the Low Anterior Resection Syndrome score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 42, with higher scores indicating worse bowel dysfunction.
Measured: 7 days, 14 days, and 1 month after surgery
Quality of Recovery Score Within 1 Month After Surgery
Quality of postoperative recovery will be assessed using the Quality of Recovery-15 score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
Measured: 7 days, 14 days, and 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start17 Nov 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo ultra-low anterior resection without prophylactic stoma and will receive somatostatin plus a clear liquid diet for 7 days after surgery. The control group will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ezhou Central Hospital, Shanxi Bethune Hospital, Taihe Hospital affiliated to Hubei University of Medicine, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
- Responsible party
- Principal investigator, Lai Senyan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605611
- Sponsor's protocol ID
- TJ-IRB202601038
- Acronym
- SC-Stoma
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves clinical surgical data and long-term follow-up information from patients with rectal cancer. Data will be stored in a de-identified form for study analysis, but external sharing of individual participant data is not planned under the current ethics approval and informed consent process.
Publications
Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.
PubMed 22986932Stevens P, Foulkes RE, Hartford-Beynon JS, Delicata RJ. Systematic review and meta-analysis of the role of somatostatin and its analogues in the treatment of enterocutaneous fistula. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):912-22. doi: 10.1097/MEG.0b013e32834a345d.
PubMed 21814141Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Kulu Y, Ulrich A, Bruckner T, Contin P, Welsch T, Rahbari NN, Buchler MW, Weitz J; International Study Group of Rectal Cancer. Validation of the International Study Group of Rectal Cancer definition and severity grading of anastomotic leakage. Surgery. 2013 Jun;153(6):753-61. doi: 10.1016/j.surg.2013.02.007. Epub 2013 Apr 25.
PubMed 23623834Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
PubMed 20004450Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
PubMed 17667498
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection
- ClinicalTrials.gov ID
- NCT07605611
- Acronym / sponsor ID
- SC-Stoma / TJ-IRB202601038
- Conditions
- Rectal Cancer, Anastomotic Leakage
- Keywords
- Rectal cancer, Ultra-low anterior resection, Anastomotic leakage, Severe anastomotic leakage, Diverting stoma, Prophylactic stoma, Somatostatin, Clear liquid diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Ezhou Central Hospital, Shanxi Bethune Hospital, Taihe Hospital affiliated to Hubei University of Medicine, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 26 May 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 goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery.
The main questions it aims to answer are:
Does somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma?
What medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up?
Researchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation.
Participants will:
Have rectal cancer surgery with the bowel joined very close to the anus
Be randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma
Have follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life
Complete follow-up visits or assessments for up to 3 years after surgery
Detailed description
This is a multicenter, open-label, randomized clinical trial evaluating a postoperative no-stoma management strategy in adults with low or mid rectal cancer undergoing ultra-low anterior resection. Patients undergoing ultra-low colorectal or coloanal anastomosis are at increased risk of anastomotic leakage. A prophylactic diverting stoma is commonly used to reduce the clinical consequences of leakage, but stoma creation may also lead to stoma-related complications, delayed stoma closure, additional surgery, and impaired quality of life.
The study evaluates whether a 7-day postoperative regimen of somatostatin plus a clear liquid diet can serve as an alternative strategy to reduce intestinal contents passing through the anastomosis during the early postoperative period. Somatostatin is used to reduce gastrointestinal secretions, and a clear liquid diet is used to limit solid residue in the digestive tract. The investigational strategy is compared with prophylactic diverting stoma, which is commonly used in patients considered to be at high risk of leakage after low rectal surgery.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment strategies after ultra-low anterior resection. Participants in the experimental group will not undergo prophylactic stoma creation and will receive somatostatin plus a clear liquid diet for 7 days after surgery. Participants in the control group will undergo prophylactic diverting stoma and receive standard postoperative care. Both groups will receive routine perioperative management according to clinical practice at the participating centers.
The primary clinical focus is severe anastomotic leakage within 1 month after surgery, defined as leakage requiring reoperation. The study will also assess postoperative complications, bowel function, quality of recovery, quality of life, and longer-term functional outcomes during follow-up. Participants will be followed for up to 3 years after surgery.
This trial is intended to determine whether somatostatin plus a clear liquid diet without prophylactic stoma can provide similar protection against severe anastomotic leakage compared with prophylactic diverting stoma, while reducing the need for stoma creation and its related burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo ultra-low anterior resection without prophylactic stoma and will receive somatostatin plus a clear liquid diet for 7 days after surgery. The control group will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care.
| Arm | Type | Receives |
|---|---|---|
| Somatostatin Plus Clear Liquid Diet Without Diverting Stoma | Experimental | Drug: Somatostatin, Other: Clear Liquid DietParticipants in this arm will undergo ultra-low anterior resection without prophylactic diverting stoma. After surgery, they will receive somatostatin plus a clear liquid diet for 7 days, along with routine postoperative care. |
| Prophylactic Diverting Stoma | Active comparator | Procedure: Prophylactic Diverting StomaParticipants in this arm will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 75 years
- Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
- The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination
- The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
- Patients have two or more risk factors for anastomotic leakage as assessed by the study team
Key exclusion criteria (11 listed)
- Has another colorectal malignant tumor at the same time
- The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
- Has metastatic disease before surgery
- Is pregnant
- Has a mental illness or addictive disorder that would prevent participation in the clinical trial
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 |
|---|---|---|
| SomatostatinParticipants in the experimental arm will receive somatostatin 3 mg diluted in 50 mL of 0.9% sodium chloride by intravenous infusion pump at 4.1 mL/hour every 12 hours for 7 days after surgery, as part of the postoperative no-stoma management strategy. | Drug | Somatostatin Plus Clear Liquid Diet Without Diverting Stoma |
| Clear Liquid DietParticipants in the experimental arm will receive a clear liquid diet after recovery of bowel gas passage, as part of the 7-day postoperative no-stoma management strategy. Parenteral nutrition may be provided according to clinical needs. | Other | Somatostatin Plus Clear Liquid Diet Without Diverting Stoma |
| Prophylactic Diverting StomaParticipants in the control arm will undergo prophylactic diverting stoma creation during ultra-low anterior resection and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary. | Procedure or surgery | Prophylactic Diverting Stoma |
Primary outcome
Grade C Anastomotic Leakage Within 1 Month After Surgery
Time frame: Within 1 month after surgery
Proportion of participants who develop grade C anastomotic leakage within 1 month after surgery. Grade C anastomotic leakage is defined as anastomotic leakage requiring reoperation.
3 secondary outcomes
Postoperative Complication Severity Within 1 Month After Surgery
Time frame: Within 1 month after surgery
Low Anterior Resection Syndrome Score Within 1 Month After Surgery
Time frame: 7 days, 14 days, and 1 month after surgery
Quality of Recovery Score Within 1 Month After Surgery
Time frame: 7 days, 14 days, and 1 month after surgery
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 26 May 2026.
- Background: PubMed 22986932Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.
- Background: PubMed 21814141Stevens P, Foulkes RE, Hartford-Beynon JS, Delicata RJ. Systematic review and meta-analysis of the role of somatostatin and its analogues in the treatment of enterocutaneous fistula. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):912-22. doi: 10.1097/MEG.0b013e32834a345d.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 23623834Kulu Y, Ulrich A, Bruckner T, Contin P, Welsch T, Rahbari NN, Buchler MW, Weitz J; International Study Group of Rectal Cancer. Validation of the International Study Group of Rectal Cancer definition and severity grading of anastomotic leakage. Surgery. 2013 Jun;153(6):753-61. doi: 10.1016/j.surg.2013.02.007. Epub 2013 Apr 25.
- Background: PubMed 20004450Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
- Background: PubMed 17667498Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves clinical surgical data and long-term follow-up information from patients with rectal cancer. Data will be stored in a de-identified form for study analysis, but external sharing of individual participant data is not planned under the current ethics approval and informed consent process.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatostatin, Clear Liquid Diet and Prophylactic Diverting Stoma in people with Rectal Cancer and Anastomotic Leakage, run by Tongji Hospital at 3 sites 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 8 inclusion and 11 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 26 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 3 sites 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 Antian Lu (+8613208585786, lat0061@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade C Anastomotic Leakage Within 1 Month After Surgery (time frame: Within 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605611, which also lists 7 linked publications.
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 26 May 2026.