Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection (SC-Stoma)
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:
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Antian Lu
- Telefonní číslo: +8613208585786
- E-mail: lat0061@163.com
Studijní záloha kontaktů
- Jméno: Senyan Lai
- Telefonní číslo: +86 8366 3000 67933
- E-mail: laisenyan@163.com
Studijní místa
-
-
Hubei
-
Ezhou, Hubei, Čína
- Nábor
- Ezhou Central Hospital
-
Kontakt:
- Antian Lu
- Telefonní číslo: +8613208585786
- E-mail: lat0061@163.com
-
Wuhan, Hubei, Čína
- Nábor
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Kontakt:
- Antian Lu
- Telefonní číslo: +8613208585786
- E-mail: lat0061@163.com
-
Wuhan, Hubei, Čína
- Zatím nenabíráme
- Wuhan No. 6 Hospital
-
Kontakt:
- Antian Lu
- Telefonní číslo: +8613208585786
- E-mail: lat0061@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Somatostatin Plus Clear Liquid Diet Without Diverting Stoma
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.
|
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.
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.
|
|
Aktivní komparátor: Prophylactic Diverting Stoma
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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Grade C Anastomotic Leakage Within 1 Month After Surgery
Časové okno: 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.
|
Within 1 month after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Complication Severity Within 1 Month After Surgery
Časové okno: 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.
|
Within 1 month after surgery
|
|
Low Anterior Resection Syndrome Score Within 1 Month After Surgery
Časové okno: 7 days, 14 days, and 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.
|
7 days, 14 days, and 1 month after surgery
|
|
Quality of Recovery Score Within 1 Month After Surgery
Časové okno: 7 days, 14 days, and 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.
|
7 days, 14 days, and 1 month after surgery
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Low Anterior Resection Syndrome Score During Long-term Follow-up
Časové okno: 3 months, 6 months, 1 year, and 3 years after surgery
|
Bowel dysfunction after low anterior resection will be assessed using the Low Anterior Resection Syndrome score at 3 months, 6 months, 1 year, and 3 years after surgery.
The total score ranges from 0 to 42, with higher scores indicating worse bowel dysfunction.
|
3 months, 6 months, 1 year, and 3 years after surgery
|
|
Quality of Recovery Score During Long-term Follow-up
Časové okno: 3 months, 6 months, 1 year, and 3 years after surgery
|
Quality of postoperative recovery and patient-reported health status will be assessed using the Quality of Recovery-15 score at 3 months, 6 months, 1 year, and 3 years after surgery.
The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
|
3 months, 6 months, 1 year, and 3 years after surgery
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Matthiessen 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.
- Stark 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.
- Emmertsen 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.
- 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.
- Rahbari 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.
- Stevens 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.
- Kulu 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.
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Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Pooperační komplikace
- Patologické procesy
- Novotvary podle místa
- Novotvary
- Střevní nemoci
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Kolorektální novotvary
- Střevní novotvary
- Rektální onemocnění
- Patologické stavy, příznaky a symptomy
- Rektální novotvary
- Anastomotický únik
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Hypothalamické hormony
- Peptidové hormony
- Neuropeptidy
- Peptidy
- Aminokyseliny, peptidy a proteiny
- Proteiny nervové tkáně
- Proteiny
- Pankreatické hormony
- Uvolňování hormonů hypofýzy inhibující hormony
- Somatostatin
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