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Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection (SC-Stoma)

22 maja 2026 zaktualizowane przez: Lai Senyan, Tongji Hospital

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

72

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Hubei
      • Ezhou, Hubei, Chiny
        • Rekrutacyjny
        • Ezhou Central Hospital
        • Kontakt:
      • Wuhan, Hubei, Chiny
        • Rekrutacyjny
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
      • Wuhan, Hubei, Chiny
        • Jeszcze nie rekrutacja
        • Wuhan No. 6 Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Adults aged 18 to 75 years
  2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
  3. 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
  4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
  5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team
  6. American Society of Anesthesiologists physical status classification is grade 3 or lower
  7. Body mass index is less than 30 kg/m²
  8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent

Exclusion Criteria:

  1. Has another colorectal malignant tumor at the same time
  2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
  3. Has metastatic disease before surgery
  4. Is pregnant
  5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial
  6. Requires emergency surgery
  7. Has inflammatory bowel disease
  8. Is allergic to somatostatin or is unable to tolerate somatostatin
  9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required
  10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery
  11. Has any other condition that makes it impossible to follow the study protocol

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Somatostatin
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.
Inny: Clear Liquid Diet
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.
Aktywny komparator: 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.
Procedura: Prophylactic Diverting Stoma
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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Grade C Anastomotic Leakage Within 1 Month After Surgery
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Postoperative Complication Severity Within 1 Month After Surgery
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Low Anterior Resection Syndrome Score During Long-term Follow-up
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tongji Hospital

Współpracownicy

Shanxi Bethune Hospital
Ezhou Central Hospital
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Taihe Hospital affiliated to Hubei University of Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 listopada 2025

Zakończenie podstawowe (Szacowany)

31 lipca 2027

Ukończenie studiów (Szacowany)

30 czerwca 2030

Daty rejestracji na studia

Pierwszy przesłany

16 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TJ-IRB202601038

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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