D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

September 19, 2023 updated by: Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt

D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy In Right Cancer Colon Patients: A Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

  1. 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.
  2. A 10-mm trocar will be introduced 10 cm below the umbilicus for the surgeon's right hand
  3. 5-mm McBurney's point port will be placed for the left-hand instrument.
  4. 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.

  1. A 30º-angled scope placed through port from an incision through the umbilicus.
  2. A 10-mm trocar will be introduced at left lumbar region for right working hand.
  3. A 5-mm trocar will be introduced at left iliac region for left working hand.
  4. A 10-mm trocar will be introduced at suprapubic for the assistant.
  5. 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • The surgical department of Medical Research Institute Hospital, Alexandria University
        • Contact:
          • M. H. Ashour, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic hemicolectomy with Complete Mesocolic Excision
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention)
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
Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Drug: Levofloxacin 500mg
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
Active Comparator: Conventional laparoscopic right hemicolectomy
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Drug: Levofloxacin 500mg
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of blood units needed
Time Frame: during the intervention/procedure/surgery
Guided by hemoglobine levels during surgery
during the intervention/procedure/surgery
Number of post-operative ICU admission
Time Frame: immediately after the intervention/procedure/surgery
Incidence of ICU admission after surgery
immediately after the intervention/procedure/surgery
Number of anastomotic leakage
Time Frame: Within 30 days post-operative
incidence of anastomotic leakage
Within 30 days post-operative
Number of lymph node harvesting in the final specimen
Time Frame: 6 months post-operative
incidence of lymph node
6 months post-operative
Number of postoperative outcomes
Time Frame: 6 months post-operative
the medical condition from the patient
6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival time after 5-years
Time Frame: 5 years post-operative
Survival analysis
5 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Investigators

  • Principal Investigator: Medhat Mohamed Anwar Hamed, Prof, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2024

Primary Completion (Estimated)

January 2, 2026

Study Completion (Estimated)

January 2, 2030

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlexUni_D2D3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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