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D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

Primary Purpose

Blood Loss, Intensive Care, Anastomotic Leakage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention)
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Levofloxacin 500mg
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)
Sponsored by
General Committee of Teaching Hospitals and Institutes, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with right-side colon cancer (caecum, ascending, or hepatic flexure) Diagnosed by CT entero-colonography Diagnosed by colonoscopy Diagnosed by biopsy. Exclusion Criteria: Emergency surgery (obstruction, perforation with generalized peritonitis), Metastatic tumor diagnosed ASA score of IV or higher Need for more than one surgical procedure Conversion to open surgery

Sites / Locations

  • The surgical department of Medical Research Institute Hospital, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic hemicolectomy with Complete Mesocolic Excision

Conventional laparoscopic right hemicolectomy

Arm Description

Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.

Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.

Outcomes

Primary Outcome Measures

Number of blood units needed
Guided by hemoglobine levels during surgery
Number of post-operative ICU admission
Incidence of ICU admission after surgery
Number of anastomotic leakage
incidence of anastomotic leakage
Number of lymph node harvesting in the final specimen
incidence of lymph node
Number of postoperative outcomes
the medical condition from the patient

Secondary Outcome Measures

Overall survival time after 5-years
Survival analysis

Full Information

First Posted
June 12, 2023
Last Updated
September 19, 2023
Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT06049758
Brief Title
D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy
Official Title
D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy In Right Cancer Colon Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2024 (Anticipated)
Primary Completion Date
January 2, 2026 (Anticipated)
Study Completion Date
January 2, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluating the differences between D2 and D3 lymphadenectomy in laparoscopic right hemicolectomy in patients with right cancer colon post-operative outcome, intra-operative blood transfusion, post-operative ICU admission, anastomotic leakage, lymph node harvesting in the final specimen, and six months follow up and overall survival time after 5-years
Detailed Description
Surgical Technique and Preparation Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation, and Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation. Procedures will be performed under general anesthesia. Group A: Location of trocars and surgeons: The patient will be placed in the Trendelenburg position and tilt to the left, with the surgeon standing between the patient's legs, the camera operator standing on the patient's left side, the assistant standing on the right of the camera operator, and the scrub nurse standing on the patient's right side. A 30º-angled scope placed through port from an incision 5 cm below the umbilicus and two cm to the left to get an adequate view. A 10-mm trocar will be introduced 10 cm below the umbilicus for the surgeon's right hand 5-mm McBurney's point port will be placed for the left-hand instrument. An additional two 5-mm trocars will be placed at the opposite McBurney's point and the left subcostal position for the assistant to retract and display the colon and mesocolon. Surgical approach group A Tumor presence is confirmed by visual and tactile examination after thorough abdominal exploration. First, the omentum will be turned up to the upper quadrant and the small intestine will be moved to the left, and the ileocecal junction and the root of the mesentery will be exposed. Then, the appendix or caecum will be grasped and retracted in a lateral, anterior, and cranial direction by the assistant's left hand; the last ileal loop will be grasped and elevated by the assistant's right hand with an atraumatic bowel grasping forceps. Therefore, the mesentery root will be put under tension by this suspension. Retrocolic dissection by cutting the peritoneum along the line between the right mesocolon and retroperitoneum) along the caudal aspect of the root and 1 cm above the right iliac vessels, as the entry for separation of the fusion fascial space between the visceral and parietal peritoneum (toldt fascia). The right Toldt's fascia will be dissected and expanded medial to the periphery of the superior mesenteric vein (SMV), cranial to the pancreas head, and lateral to the ascending colon. The posterior paries of ileocolic vessels (ICVs), right colic vessels (RCVs), and Henle's of gastro-colic trunk will be exposed. Second, the mesocolon between the ICV and SMV will be dissected safely, and the ICV, RCV, and right gastroepiploic vessels as well as the right branch of the middle colic vessel will be divided and ligated easily because of the separated retroperitoneal space. The lymph nodes along the SMV and SMA will be dissected using a caudal-to-cranial approach. The greater omentum will be dissected for full mobilization of the mesocolon containing 10 cm of normal colon distal to the lesion followed by complete mobilization of the lateral attachments of the ascending colon. Using laparoscopic stapler division of the transverse colon 10 cm distal to the tumor and last 20 cm of the ileum. Anastomosis: A functional side-to-side ileocolic intracorporeal anastomosis between the ileum and the transverse colon will be performed by liner stapler then closing enterostomy using 3/0 vicryl. Extraction: of the specimen through a midline or pfannenstiel incision; the incision length will be about 5-6 cm. A drain will be placed in the pelvis. Group B: Location of trocars and surgeons: The patient will be placed in the Trendelenburg position and tilt to the left; the main surgeon and camera operator will stand to the left of the patient and the second assistant will be between the legs of the patient. A 30º-angled scope placed through port from an incision through the umbilicus. A 10-mm trocar will be introduced at left lumbar region for right working hand. A 5-mm trocar will be introduced at left iliac region for left working hand. A 10-mm trocar will be introduced at suprapubic for the assistant. A 5-mm trocar will be introduced at right sub costal for the assistant. Surgical approach group B First, the pedicle of ileocolic vessels will be identified and the mesocolon will be dissected between the pedicle and the periphery of the Superior mesenteric vein(SMV)to expose the second portion of the duodenum. The ileocolic vessels will then cut at their roots. The ascending mesocolon will be separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon. Using laparoscopic stapler division of the transverse colon 10 cm distal to the tumor and the last 20 cm of the ileum. Anastomosis: A liner stapler will perform a functional side-to-side ileocolic intracorporeal anastomosis between the ileum and the transverse colon, then closing enterostomy using 3/0 vicryl. Extraction: The specimen will go through a midline or Pfannenstiel incision; the length of the incision will be about 5-6 cm. A drain will be placed in the pelvis. This approach is the medial-to-lateral (MtL) approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Intensive Care, Anastomotic Leakage, Lymph Node Disease, Survival, Blood Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial, single-blind, with randomized block randomization
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic hemicolectomy with Complete Mesocolic Excision
Arm Type
Active Comparator
Arm Description
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
Arm Title
Conventional laparoscopic right hemicolectomy
Arm Type
Active Comparator
Arm Description
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention)
Intervention Description
Patients with right-side colon cancer (caecum, ascending, or hepatic flexure); were diagnosed by CT entero-colonography, colonoscopy, and biopsy who undergo laparoscopic right hemicolectomy
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Intervention Description
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 500mg
Intervention Description
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
Intervention Type
Procedure
Intervention Name(s)
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)
Intervention Description
Patients with right-side colon cancer (caecum, ascending, or hepatic flexure); were diagnosed by CT entero-colonography, colonoscopy, and biopsy who undergo laparoscopic right hemicolectomy
Primary Outcome Measure Information:
Title
Number of blood units needed
Description
Guided by hemoglobine levels during surgery
Time Frame
during the intervention/procedure/surgery
Title
Number of post-operative ICU admission
Description
Incidence of ICU admission after surgery
Time Frame
immediately after the intervention/procedure/surgery
Title
Number of anastomotic leakage
Description
incidence of anastomotic leakage
Time Frame
Within 30 days post-operative
Title
Number of lymph node harvesting in the final specimen
Description
incidence of lymph node
Time Frame
6 months post-operative
Title
Number of postoperative outcomes
Description
the medical condition from the patient
Time Frame
6 months post-operative
Secondary Outcome Measure Information:
Title
Overall survival time after 5-years
Description
Survival analysis
Time Frame
5 years post-operative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with right-side colon cancer (caecum, ascending, or hepatic flexure) Diagnosed by CT entero-colonography Diagnosed by colonoscopy Diagnosed by biopsy. Exclusion Criteria: Emergency surgery (obstruction, perforation with generalized peritonitis), Metastatic tumor diagnosed ASA score of IV or higher Need for more than one surgical procedure Conversion to open surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M. H Ashour, MD
Phone
‭+20 100 2600970‬
Email
mohamed.ashour@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medhat Mohamed Anwar Hamed, Prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The surgical department of Medical Research Institute Hospital, Alexandria University
City
Alexandria
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. H. Ashour, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
IPD Sharing Time Frame
whole study period
IPD Sharing Access Criteria
ask contact person
Citations:
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19071061
Citation
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Results Reference
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Results Reference
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Citation
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D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

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