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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
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic hemicolectomy with Complete Mesocolic Excision | Active Comparator | Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection. |
|
| Conventional laparoscopic right hemicolectomy | Active Comparator | Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of blood units needed | Guided by hemoglobine levels during surgery | during the intervention/procedure/surgery |
| Number of post-operative ICU admission | Incidence of ICU admission after surgery | immediately after the intervention/procedure/surgery |
| Number of anastomotic leakage | incidence of anastomotic leakage | Within 30 days post-operative |
| Number of lymph node harvesting in the final specimen | incidence of lymph node | 6 months post-operative |
| Number of postoperative outcomes | the medical condition from the patient | 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time after 5-years | Survival analysis | 5 years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M. H Ashour, MD | Contact | â€+20 100 2600970‬ | mohamed.ashour@alexu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Medhat Mohamed Anwar Hamed, Prof | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19071061 | Background | 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. | |
| 17562120 |
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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
whole study period
ask contact person
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randomized controlled trial, single-blind, with randomized block randomization
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| Enoxaparin 40 Mg/0.4 mL Injectable Solution | Drug | Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation |
|
| Levofloxacin 500mg | Drug | Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation. |
|
| LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional) | Procedure | 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 |
|
| Background |
| 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. |
| 22549374 | Background | 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. |
| 26194254 | Background | 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. |
| 22002491 | Background | 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. |
| 24566862 | Background | 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. |
| 24126120 | Background | 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. |
| 18941759 | Background | 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. |
| 24357446 | Background | 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. |
| 27824707 | Background | 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. |
| 18487245 | Background | 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. |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D017984 | Enoxaparin |
| D064704 | Levofloxacin |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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