D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy
NCT ID: NCT06049758
Last Updated: 2023-09-22
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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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-01-02
2030-01-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Laparoscopic hemicolectomy with Complete Mesocolic Excision
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
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
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Levofloxacin 500mg
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
Conventional laparoscopic right hemicolectomy
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Levofloxacin 500mg
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
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
Interventions
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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
Enoxaparin 40 Mg/0.4 mL Injectable Solution
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Levofloxacin 500mg
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
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
Eligibility Criteria
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Inclusion Criteria
* Diagnosed by CT entero-colonography
* Diagnosed by colonoscopy
* Diagnosed by biopsy.
Exclusion Criteria
* Metastatic tumor diagnosed
* ASA score of IV or higher
* Need for more than one surgical procedure
* Conversion to open surgery
ALL
Yes
Sponsors
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General Committee of Teaching Hospitals and Institutes, Egypt
OTHER_GOV
Responsible Party
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Mohamed Hany Ashour
Principal Investigator
Principal Investigators
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Medhat Mohamed Anwar Hamed, Prof
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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M. H. Ashour, MD
Role: primary
References
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Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.
Pigazzi A, Hellan M, Ewing DR, Paz BI, Ballantyne GH. Laparoscopic medial-to-lateral colon dissection: how and why. J Gastrointest Surg. 2007 Jun;11(6):778-82. doi: 10.1007/s11605-007-0120-4.
Adamina M, Manwaring ML, Park KJ, Delaney CP. Laparoscopic complete mesocolic excision for right colon cancer. Surg Endosc. 2012 Oct;26(10):2976-80. doi: 10.1007/s00464-012-2294-4. Epub 2012 May 2.
Benz S, Tam Y, Tannapfel A, Stricker I. The uncinate process first approach: a novel technique for laparoscopic right hemicolectomy with complete mesocolic excision. Surg Endosc. 2016 May;30(5):1930-7. doi: 10.1007/s00464-015-4417-1. Epub 2015 Jul 21.
Watanabe T, Itabashi M, Shimada Y, Tanaka S, Ito Y, Ajioka Y, Hamaguchi T, Hyodo I, Igarashi M, Ishida H, Ishiguro M, Kanemitsu Y, Kokudo N, Muro K, Ochiai A, Oguchi M, Ohkura Y, Saito Y, Sakai Y, Ueno H, Yoshino T, Fujimori T, Koinuma N, Morita T, Nishimura G, Sakata Y, Takahashi K, Takiuchi H, Tsuruta O, Yamaguchi T, Yoshida M, Yamaguchi N, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer. Int J Clin Oncol. 2012 Feb;17(1):1-29. doi: 10.1007/s10147-011-0315-2. Epub 2011 Oct 15.
Kobayashi H, West NP, Takahashi K, Perrakis A, Weber K, Hohenberger W, Quirke P, Sugihara K. Quality of surgery for stage III colon cancer: comparison between England, Germany, and Japan. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S398-404. doi: 10.1245/s10434-014-3578-9. Epub 2014 Feb 25.
Willaert W, Mareel M, Van De Putte D, Van Nieuwenhove Y, Pattyn P, Ceelen W. Lymphatic spread, nodal count and the extent of lymphadenectomy in cancer of the colon. Cancer Treat Rev. 2014 Apr;40(3):405-13. doi: 10.1016/j.ctrv.2013.09.013. Epub 2013 Sep 25.
Lee SD, Lim SB. D3 lymphadenectomy using a medial to lateral approach for curable right-sided colon cancer. Int J Colorectal Dis. 2009 Mar;24(3):295-300. doi: 10.1007/s00384-008-0597-7. Epub 2008 Oct 21.
Storli KE, Sondenaa K, Furnes B, Nesvik I, Gudlaugsson E, Bukholm I, Eide GE. Short term results of complete (D3) vs. standard (D2) mesenteric excision in colon cancer shows improved outcome of complete mesenteric excision in patients with TNM stages I-II. Tech Coloproctol. 2014 Jun;18(6):557-64. doi: 10.1007/s10151-013-1100-1. Epub 2013 Dec 20.
Bertelsen CA, Kirkegaard-Klitbo A, Nielsen M, Leotta SM, Daisuke F, Gogenur I. Pattern of Colon Cancer Lymph Node Metastases in Patients Undergoing Central Mesocolic Lymph Node Excision: A Systematic Review. Dis Colon Rectum. 2016 Dec;59(12):1209-1221. doi: 10.1097/DCR.0000000000000658.
Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
Other Identifiers
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AlexUni_D2D3
Identifier Type: -
Identifier Source: org_study_id
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