D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

NCT06049758 | Not Yet Recruiting

• 1 other identifier: AlexUni_D2D3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Loss; Intensive Care; Anastomotic Leakage; Lymph Node Disease; Survival; Blood Transfusion

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• Overall survival time after 5-years

  5 years post-operative

Study Arms (2)

Laparoscopic hemicolectomy with Complete Mesocolic Excision

ACTIVE COMPARATOR

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

Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention); Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution; Drug: Levofloxacin 500mg

Conventional laparoscopic right hemicolectomy

ACTIVE COMPARATOR

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

Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution; Drug: Levofloxacin 500mg; Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)

Interventions

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

Laparoscopic hemicolectomy with Complete Mesocolic Excision

Enoxaparin 40 Mg/0.4 mL Injectable Solution DRUG

Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation

Conventional laparoscopic right hemicolectomy; Laparoscopic hemicolectomy with Complete Mesocolic Excision

Levofloxacin 500mg DRUG

Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.

Conventional laparoscopic right hemicolectomy; Laparoscopic hemicolectomy with Complete Mesocolic Excision

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

Conventional laparoscopic right hemicolectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)
• Diagnosed by CT entero-colonography
• Diagnosed by colonoscopy
• Diagnosed by biopsy.

You may not qualify if:

• 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

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt

Location

Related Publications (11)

• 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.

  PMID: 19071061 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.

  PMID: 17562120 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.

  PMID: 22549374 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.

  PMID: 26194254 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.

  PMID: 22002491 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.

  PMID: 24566862 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.

  PMID: 24126120 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.

  PMID: 18941759 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.

  PMID: 24357446 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.

  PMID: 27824707 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.

  PMID: 18487245 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Anastomotic Leak

Interventions

Methods; Enoxaparin; Levofloxacin; Congresses as Topic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Investigative Techniques; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Organizations; Health Care Economics and Organizations

Study Officials

• Medhat Mohamed Anwar Hamed, Prof

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. H Ashour, MD

CONTACT

‭+20 100 2600970‬; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial, single-blind, with randomized block randomization

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: September 22, 2023
• Study Start: January 2, 2024
• Primary Completion: January 2, 2026
• Study Completion (Estimated): January 2, 2030
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: whole study period
• Access Criteria: ask contact person

Locations

EG (1)