Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) (CMELL)
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|ClinicalTrials.gov Identifier: NCT03083951|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2017
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Sigmoid Cancer||Procedure: Complete mesocolon excision Procedure: Conventional locoregional lymphadenectomy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.|
|Masking Description:||The patient does not know the group to which it has been assigned.|
|Official Title:||Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)|
|Estimated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2023|
Experimental: Complete Mesocolon Excision
A high tie of the inferior mesenteric artery (IMA) should be attempted. The inferior mesenteric vein section at the Treitz angle should be performed. The lymphatic tissue that accompanies the inferior mesenteric vein should be added.
Procedure: Complete mesocolon excision
Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)
Active Comparator: Conventional Locoregional Lymphadenectomy
A high tie of the inferior mesenteric artery (IMA) should be attempted. Lymphadenectomy of the lymphatic tissue that accompanies the IMA will be performed. The inferior mesenteric vein section could be performed at the discretion of the surgeon.
Procedure: Conventional locoregional lymphadenectomy
Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.
- Total number of lymph nodes and lymph node ratio. [ Time Frame: 30 days ]To compare the total number of lymph nodes resected and the lymph node ratio (definded as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.
- Local recurrence [ Time Frame: 5 years ]To compare the tumor local recurrence rate between the two arms.
- Survival [ Time Frame: 5 years ]To compare the survival rate (deaths from cancer) between the two arms
- Postoperative complications [ Time Frame: 90 days ]Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
- Anastomotic leakage [ Time Frame: 90 days ]To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.
- Intraoperative outcomes: duration of surgery [ Time Frame: 1 day ]To compare the duration of surgery measured in minutes between the two arms
- Intraoperative outcomes: surgical bleeding [ Time Frame: 1 day ]To compare the surgical bleeding measured in ml between the two arms
- Intraoperative outcomes: surgical conversion [ Time Frame: 1 day ]To compare the incidence of surgical conversion to laparotomy between the two arms
- Genitourinary dysfunction assesed by ICIQ-SF questionnaire [ Time Frame: 1 year ]To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire
- Defecatory dysfunction assesed by FSFI and erectile dysfunction questionnaires [ Time Frame: 1 year ]To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083951
|Contact: Pere Planellas Giné||972 940 256 ext email@example.com|
|Contact: Antoni Codina Cazador||972 940 256 ext firstname.lastname@example.org|