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- Klinische Studie NCT07655856
Inferior Mesenteric Artery First Combined With Complete Medial Approach for Laparoscopic Splenic Flexure Mobilization in Left Sided Colorectal Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Laparoscopic left-sided colon cancer radical resection is primarily employed for the treatment of tumors located in distal transverse colon , splenic flexure of colon, descending colon, and proximal segment of the sigmoid colon. Numerous factors impact the difficulty of surgery, with research suggesting that mobilization of the splenic flexure independently predicts longer operative times in laparoscopic left-sided colon cancer radical resection . Splenic flexure mobilization is independently associated with an increased risk of splenic injury, which contributes to elevated short-term and long-term mortality risks in patients. The crucial aspect of radical surgery is complete mesocolic excision (CME) with central vascular ligation and the Japanese D3 lymphadenectomy. For tumors located in descending colon and sigmoid-descending junction, the lymph node dissection range includes the central lymph node group (No.253) at the root of the inferior mesenteric artery (IMA) . In cases of cancer in the left half of the transverse colon or in the splenic flexure of colon, in addition to IMA root lymph node dissection, it is imperative to perform dissection of lymph nodes (No.223) at the root of the middle colic artery (MCA).Therefore, for laparoscopic left-sided colon cancer radical resection, ensuring the safety of splenic flexure mobilization and maintaining the quality of lymph nodes dissection are both crucial.
Currently, traditional surgical approaches for laparoscopic left-sided colon cancer radical resection include the medial approach, lateral approach, anterior approach, and various combinations of these methods. Due to variations in anatomical understanding, many teams propose the combined application of multiple approaches, each demonstrating a certain level of safety and feasibility.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: omar mohamed doctor, master
- Telefonnummer: +0201025104556
- E-Mail: Omar_Mokbel@aun.edu.eg
Studieren Sie die Kontaktsicherung
- Name: momen shalkamy abdelgwad, phd
- Telefonnummer: 01017520093
- E-Mail: moamen.shalkamy@aun.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Patients aged 18-70 years old with confirmed colorectal cancer diagnosis by histopathology with obligatory splenic flexure mobilization and had laparoscopic surgery with curative intent were included.
Exclusion Criteria:
- Those younger than 18 years or older than 70 years.
- Those undergoing non-cancer resections, or completion surgery or palliative procedures.
- Those with locally advanced ( extra colonic extension ) or metastatic tumors.
- Those with advanced comorbidities ( laparoscopy is contraindicated )
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: inferior mesenteric artery first with complete medial approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
|
Aktiver Komparator: lateral approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
evaluation of safety and effectiveness of inferior mesenteric artery first in combination with complete medial approach in splenic mobilization in left sided colorectal cancer .
Zeitfenster: 6 month
|
number of harvested lymph nodes
|
6 month
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- laparoscopic colorectal cancer
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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