Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
NCT ID: NCT04977882
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
36 participants
INTERVENTIONAL
2020-10-01
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Abdominal drainage
19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
abdominal drainage
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
Laparoscopic standard D2 right hemicolectomy (STANDARD)
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
Postoperative antibiotico-prophylaxis
postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
Postoperative antibiotico-prophylaxis
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
Laparoscopic standard D2 right hemicolectomy (STANDARD)
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
Control group
No drainage nor postoperative antibiotico-prophylaxis
Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
Laparoscopic standard D2 right hemicolectomy (STANDARD)
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
Interventions
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abdominal drainage
19 Fr abdominal drainage placed intraoperatively in right colic gutter
Postoperative antibiotico-prophylaxis
Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
the dissection starts over the landmark given by SMV. The SMV is freed anteriorly and on its right-hand side from all the lympho-adipose tissue. Once the SMV is fully exposed, the IC vessels are dissected and divided at the junction with the efferent vessels. The dissection moves upward along the same dissection line to identify the right colic vein and the GCTH. No medial to later dissection is carried out until the SMV is completely exposed before reaching the uncinate process of the pancreas. At this point the veins to the right colon are divided but gastroepiploic vein and artery are preserved unless the tumor is located at the hepatic flexure. The divided mesentery is lifted and tilted to the right, and the medial-to-later dissection starts following the embryological plane over Fredet's fascia. The mesocolon is divided on the right side of the middle colic artery and the right branches of the middle colic vessels are divided.
Laparoscopic standard D2 right hemicolectomy (STANDARD)
A medial-to-lateral surgical dissection and high tie of the ileocolic vessels (IC) is undertaken without dissecting the anterior surface of the superior mesenteric vein (SMV). The gastro-colic trunk of Henle (GCTH) is not isolated and the right colic vein (when present) and the right branches of the middle colic vessels are taken more peripherical, during the division of the transverse mesocolon. The right gastroepiploic vessels are not dissected, nor divided, unless in proximity of the tumor
Eligibility Criteria
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Inclusion Criteria
* Intracorporeal anastomosis
* Laparoscopic surgery
* Elective surgery
* informed consent signed
Exclusion Criteria
* IBD
* ASA IV
* T4b
* Metastatic disease
* Preoperative steroids
* Conversion to open surgery
* Emergency surgery
* concomitant major operation
* preoperative infective status
* benign disease
18 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Giuseppe Sigismondo Sica
Head of Minimally Invasive Surgery Unit
Locations
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University of Rome Tor Vergata
Rome, , Italy
Countries
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References
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Sica GS, Siragusa L, Pirozzi BM, Sorge R, Baldini G, Fiorani C, Guida AM, Bellato V, Franceschilli M. Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision. Int J Colorectal Dis. 2024 Jul 6;39(1):102. doi: 10.1007/s00384-024-04657-0.
Other Identifiers
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Registro sperimentazioni XX.21
Identifier Type: -
Identifier Source: org_study_id