Clinical trial NCT06049758: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Loss
Intensive Care
Anastomotic Leakage
Lymph Node Disease
Survival
Blood Transfusion
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2023-09-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial, single-blind, with randomized block randomization
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Number of blood units needed
timeFrame: during the intervention/procedure/surgery
measure: Number of post-operative ICU admission
timeFrame: immediately after the intervention/procedure/surgery
measure: Number of anastomotic leakage
timeFrame: Within 30 days post-operative
measure: Number of lymph node harvesting in the final specimen
timeFrame: 6 months post-operative
measure: Number of postoperative outcomes
timeFrame: 6 months post-operative
Secondary outcomes:
measure: Overall survival time after 5-years
timeFrame: 5 years post-operative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: The surgical department of Medical Research Institute Hospital, Alexandria University
Study officials:
affiliation: Alexandria University
name: Medhat Mohamed Anwar Hamed, Prof
role: PRINCIPAL_INVESTIGATOR
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