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

Study Overview
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Brief Summary
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Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.

Official Title
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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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: abdominal drainage
* Drug: Postoperative antibiotico-prophylaxis
* Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)
* Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Right colon cancer Intracorporeal anastomosis Laparoscopic surgery Elective surgery informed consent signed Exclusion Criteria: below 18 years old IBD ASA IV T4b Metastatic disease Preoperative steroids Conversion to open surgery Emergency surgery concomitant major operation preoperative infective status benign disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients were initially randomized for postoperative management into three arms to receive prolonged antibiotic prophylaxis (ABX group), abdominal drain placement (DRAIN group) or neither (NONE group) (I level randomization). The same patients were further randomized for surgical technique in two arms to receive RRC (RRC group) or standard hemicolectomy with D2 dissection (STANDARD group) (II level of randomization).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal drainage<br>19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter | Procedure: abdominal drainage<br>* 19 Fr abdominal drainage placed intraoperatively in right colic gutter<br>Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)<br>* 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.<br>Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)<br>* 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<br>|
| Experimental: Postoperative antibiotico-prophylaxis<br>postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr | Drug: Postoperative antibiotico-prophylaxis<br>* Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively<br>Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)<br>* 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.<br>Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)<br>* 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<br>|
| Sham Comparator: Control group<br>No drainage nor postoperative antibiotico-prophylaxis | Procedure: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC)<br>* 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.<br>Procedure: Laparoscopic standard D2 right hemicolectomy (STANDARD)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance to solid diet | time to light diet tolerance | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White blood cell | measured thousands/mL in I and III POD | 30 days postoperatively | 
| Procalcitonine | measured ng/ml in III and V POD | 30 days postoperatively | 
| Days of hospitalization | number of days of hospitalization | 90 days postoperatively | 
| Readmission rate | rate of hospital readmission | 90 days postoperatively | 
| Mortality rate | postoperative mortality | 90 days postoperatively | 
| Surgical site infection rate | postoperative wound infection | 30 days postoperatively | 
| Anastomotic leak rate | postoperative Ileocolic anastomotic leakage | 30 days postoperatively | 
| Tolerance to liquid diet | time to clear fluid tolerance | 30 days postoperatively | 
| Time to first flatus | Time to first flatus postoperatively | 30 days postoperatively | 
| Time to first evacuation | Time to first evacuation postoperatively | 30 days postoperatively | 
| need of abdomen CTscan rate | need of abdomen CTscan | 30 days postoperatively | 
| C-Reactive Proteine | measured mg/L in I and III POD | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracorporeal anastomosis, right hemicoletomy, colon cancer