Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
1. september 2016 oppdatert av: Zhixiang Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Further study details as provided by Chinese Academy of Medical Sciences.
Studietype
Intervensjonell
Registrering (Forventet)
366
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhixiang Zhou, M.D.
- Telefonnummer: +86-139-1123-2981
- E-post: Dr_zhouzx@163.com
Studer Kontakt Backup
- Navn: Jianwei Liang, M.D.
- Telefonnummer: +86-130-7119-7461
- E-post: liangjw1976@126.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100021
- Rekruttering
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
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Hovedetterforsker:
- Zhixiang Zhou, M.D.
-
Ta kontakt med:
- Zhixiang Zhou, M.D.
- Telefonnummer: +86-139-1123-2981
- E-post: Dr_zhouzx@163.com
-
Ta kontakt med:
- Jianwei Liang, M.D.
- Telefonnummer: +86-130-7119-7461
- E-post: liangjw1976@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
- Pathological rectosigmoid adenocarcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- Tumor size of 6 cm or less;
- Eastern Cooperative Oncology Group (ECOG) score is 0-1
- American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- Informed consent
Exclusion Criteria:
- Body mass index (BMI) >30 kg/m2
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Konvensjonell laparoskopisk kirurgi
Konvensjonell laparoskopisk kirurgi for tykktarmskreft vil bli utført for pasienter i denne gruppen.
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High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer.
Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis.
The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.
Andre navn:
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Eksperimentell: transrectal specimen extraction
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
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After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor.
Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine.
An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device.
During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation.
The rectal opening was reclosed by a linear stapler.
End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Early morbidity rate
Tidsramme: 30 days
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The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
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30 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of the intervention
Tidsramme: 1 day
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Duration of surgery.
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1 day
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Peritoneal bacterial contamination
Tidsramme: 1 day
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Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
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1 day
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Pain score
Tidsramme: 14 days
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Recording of the needed analgesia guided by pain score
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14 days
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3-year disease free survival rate
Tidsramme: 3 years
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A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
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3 years
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5-year overall survival rate
Tidsramme: 5 years
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A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
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5 years
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Plasma levels of several cytokines after colorectal cancer surgery
Tidsramme: 7 days
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We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
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7 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Zhixiang Zhou, M.D., Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2015
Primær fullføring (Forventet)
1. desember 2020
Studiet fullført (Forventet)
1. desember 2025
Datoer for studieregistrering
Først innsendt
30. november 2015
Først innsendt som oppfylte QC-kriteriene
16. desember 2015
Først lagt ut (Anslag)
21. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2016
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCC2015SF-04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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