- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01979029
Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery (POTLCAORCS)
28. april 2016 opdateret af: Jian Suo
Affection on Anastomotic Blood Flow and the Lymph Nodes Dissection Between Division at the Root of the Inferior Mesenteric Artery and Preserving the Left Colic Artery in Rectum Cancer Surgery
To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Methods: The patients who got rectal carcinoma are divided into two groups.
Both groups will receive the radical resection of rectal carcinoma.
We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis.
Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA.
Expecting Results:The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula.
Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
57
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- First Hospital of Jilin University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.
- The rectum cancer is the first malignant neoplasm the patient has got.
- The cancer is solitary, and is 3cm to 20cm to the anus.
- The surgical method is limited to Dixon.
Exclusion Criteria:
- Being in the acute phase of inflammation before operation and emergency surgery.
- Patients receiving steroid medication or preoperative radiotherapy。
- Discovering macrometastasis before or in the operation.
- The rectum cancer that can't be radical resected.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: preserving the left colic artery
We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
|
The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized.
Subsequently, dissection was continued along the IMV up to the level of the root of the IMA.
Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated.
Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
|
|
Eksperimentel: not preserving the left colic artery
We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.
|
The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate.
Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The Blood Pressure of the Arterial Arcade
Tidsramme: after ligating the inferior mesentric artery or superior rectal artery
|
after ligating the inferior mesentric artery or superior rectal artery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Distal Colon Length
Tidsramme: after digestive tract reconstruction
|
after digestive tract reconstruction
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Systemic Blood Pressure
Tidsramme: after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon
|
after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Jian Suo, Dr., Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2013
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. oktober 2014
Datoer for studieregistrering
Først indsendt
25. oktober 2013
Først indsendt, der opfyldte QC-kriterier
7. november 2013
Først opslået (Skøn)
8. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Left Colic Artery
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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