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D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

ConditionsBlood LossIntensive CareAnastomotic LeakageLymph Node DiseaseSurvivalBlood Transfusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGeneral Committee of Teaching Hospitals and Institutes, Egypt

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)

Diagnosed by CT entero-colonography

Diagnosed by colonoscopy

Diagnosed by biopsy.

Disqualifiers

Emergency surgery (obstruction, perforation with generalized peritonitis),

Metastatic tumor diagnosed

ASA score of IV or higher

Need for more than one surgical procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention)

    Procedure/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 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/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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Laparoscopic hemicolectomy with Complete Mesocolic ExcisionActive comparator 3 interventions
Group B: Conventional laparoscopic right hemicolectomyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Number of blood units needed

Guided by hemoglobine levels during surgery

Time frame
during the intervention/procedure/surgery
2

Number of post-operative ICU admission

Incidence of ICU admission after surgery

Time frame
immediately after the intervention/procedure/surgery
3

Number of anastomotic leakage

incidence of anastomotic leakage

Time frame
Within 30 days post-operative
4

Number of lymph node harvesting in the final specimen

incidence of lymph node

Time frame
6 months post-operative

Secondary outcomes

1

Overall survival time after 5-years

Survival analysis

Time frame
5 years post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Committee of Teaching Hospitals and Institutes, Egypt

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: