Blood LossNCT06049758
D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy
A study testing LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention), Enoxaparin 40 Mg/0.4 mL Injectable Solution and Levofloxacin 500mg in people with Blood Loss and Intensive Care, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Intensive Care, Anastomotic Leakage
- What is being tested?
- LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention), Enoxaparin 40 Mg/0.4 mL Injectable Solution and Levofloxacin 500mg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2024to 2 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)
- Diagnosed by CT entero-colonography
- Diagnosed by colonoscopy
- Diagnosed by biopsy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria
M. H. Ashour, MD
About this study
Official title: 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
Read the 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.
- 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.
- A 10-mm trocar will be introduced 10 cm below the umbilicus for the surgeon's right hand
- 5-mm McBurney's point port will be placed for the left-hand instrument.
- 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.
- A 30º-angled scope placed through port from an incision through the umbilicus.
- A 10-mm trocar will be introduced at left lumbar region for right working hand.
- A 5-mm trocar will be introduced at left iliac region for left working hand.
- A 10-mm trocar will be introduced at suprapubic for the assistant.
- 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
- Blood Loss, Intensive Care, Anastomotic Leakage, Lymph Node Disease, Survival, Blood Transfusion
- Being tested
- LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention), Enoxaparin 40 Mg/0.4 mL Injectable Solution, Levofloxacin 500mg, LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)
- Medical subject headings
- Hemorrhage, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention)Procedure or surgery
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 SolutionDrug
Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation
Levofloxacin 500mgDrug
Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic hemicolectomy with Complete Mesocolic Excision | Active comparator | Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection. Receives: 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. Receives: Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution; Drug: Levofloxacin 500mg; Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood units needed
Guided by hemoglobine levels during surgery
Measured: during the intervention/procedure/surgery
Number of post-operative ICU admission
Incidence of ICU admission after surgery
Measured: immediately after the intervention/procedure/surgery
Number of anastomotic leakage
incidence of anastomotic leakage
Measured: Within 30 days post-operative
Number of lymph node harvesting in the final specimen
incidence of lymph node
Measured: 6 months post-operative
Number of postoperative outcomes
the medical condition from the patient
Measured: 6 months post-operative
Secondary outcomes (1)
Overall survival time after 5-years
Survival analysis
Measured: 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start2 Jan 2024 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial, single-blind, with randomized block randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
- Investigators
- Medhat Mohamed Anwar Hamed, Prof, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049758
- Sponsor's protocol ID
- AlexUni_D2D3
- Status last verified
- Sep 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 19071061Pigazzi 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.
PubMed 17562120Adamina 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.
PubMed 22549374Benz 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.
PubMed 26194254Watanabe 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.
PubMed 22002491Kobayashi 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.
PubMed 24566862Willaert 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.
PubMed 24126120Lee 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.
PubMed 18941759Storli 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.
PubMed 24357446Bertelsen 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.
PubMed 27824707Breivik 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.
PubMed 18487245
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy In Right Cancer Colon Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06049758
- Acronym / sponsor ID
- AlexUni_D2D3
- Conditions
- Blood Loss, Intensive Care, Anastomotic Leakage, Lymph Node Disease, Survival, Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- A 10-mm trocar will be introduced 10 cm below the umbilicus for the surgeon's right hand
- 5-mm McBurney's point port will be placed for the left-hand instrument.
- 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.
- A 30º-angled scope placed through port from an incision through the umbilicus.
- A 10-mm trocar will be introduced at left lumbar region for right working hand.
- A 5-mm trocar will be introduced at left iliac region for left working hand.
- A 10-mm trocar will be introduced at suprapubic for the assistant.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial, single-blind, with randomized block randomization
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic hemicolectomy with Complete Mesocolic Excision | Active comparator | Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention), Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution, Drug: Levofloxacin 500mgPatients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection. |
| Conventional laparoscopic right hemicolectomy | Active comparator | Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution, Drug: Levofloxacin 500mg, Procedure: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional)Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)
- Diagnosed by CT entero-colonography
- Diagnosed by colonoscopy
- Diagnosed by biopsy.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Laparoscopic hemicolectomy with Complete Mesocolic Excision |
| Enoxaparin 40 Mg/0.4 mL Injectable SolutionEnoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation | Drug | Conventional laparoscopic right hemicolectomy, Laparoscopic hemicolectomy with Complete Mesocolic Excision |
| Levofloxacin 500mgLevofloxacin 500 mg intravenous injection will be administered 1 hour before the operation. | Drug | Conventional laparoscopic right hemicolectomy, Laparoscopic hemicolectomy with Complete Mesocolic Excision |
| 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 | Procedure or surgery | Conventional laparoscopic right hemicolectomy |
Primary outcome
Number of blood units needed
Time frame: during the intervention/procedure/surgery
Guided by hemoglobine levels during surgery
Number of post-operative ICU admission
Time frame: immediately after the intervention/procedure/surgery
Incidence of ICU admission after surgery
Number of anastomotic leakage
Time frame: Within 30 days post-operative
incidence of anastomotic leakage
Number of lymph node harvesting in the final specimen
Time frame: 6 months post-operative
incidence of lymph node
Number of postoperative outcomes
Time frame: 6 months post-operative
the medical condition from the patient
1 secondary outcome
Overall survival time after 5-years
Time frame: 5 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 19071061Colon 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.
- Background: PubMed 17562120Pigazzi 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.
- Background: PubMed 22549374Adamina 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.
- Background: PubMed 26194254Benz 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.
- Background: PubMed 22002491Watanabe 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.
- Background: PubMed 24566862Kobayashi 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.
- Background: PubMed 24126120Willaert 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.
- Background: PubMed 18941759Lee 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.
- Background: PubMed 24357446Storli 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.
- Background: PubMed 27824707Bertelsen 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.
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- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medhat Mohamed Anwar Hamed, Prof principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention), Enoxaparin 40 Mg/0.4 mL Injectable Solution and Levofloxacin 500mg in people with Blood Loss and Intensive Care, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M. H Ashour, MD (+20 100 2600970, mohamed.ashour@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood units needed (time frame: during the intervention/procedure/surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049758, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.