Colorectal Cancer, Sigmoid Cancer
Conditions
Keywords
Complete mesocolon excision, Sigmoid cancer, Colorectal cancer
Brief summary
A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.
Interventions
PROCEDUREComplete 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)
PROCEDUREConventional 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.
Sponsors
Pere Planellas Giné
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient does not know the group to which it has been assigned.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer. * Age ≥ 18 years and \<80 years. * Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy. * Any T, any N, M0. * Intention of resection R0. * Informed consent signed by the patient and the investigator.
Exclusion criteria
* Colorectal tumor with histology other than adenocarcinoma or adenoma. * Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon. * Metastatic disease (M1). * History of colorectal cancer surgery, different from a local excision. * Inflammatory bowel disease with anatomopathological confirmation. * Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent. * Inability to read or understand any of the languages of the informed consent (Catalan, Spanish). * Another synchronous malignant disease. * Emergency surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of lymph nodes and lymph node ratio. | 30 days | To compare the total number of lymph nodes resected and the lymph node ratio (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence | 5 years | To compare the tumor local recurrence rate between the two arms. |
| Survival | 5 years | To compare the survival rate (deaths from cancer) between the two arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative outcomes: surgical bleeding | 1 day | To compare the surgical bleeding measured in ml between the two arms |
| Intraoperative outcomes: surgical conversion | 1 day | To compare the incidence of surgical conversion to laparotomy between the two arms |
| Postoperative complications | 90 days | Postoperative complications within 90 days after surgery (Clavien-Dindo classification). |
| Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires | 1 year | To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires |
| Genitourinary dysfunction assessed by ICIQ-SF questionnaire | 1 year | To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire |
| Anastomotic leakage | 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 | 1 day | To compare the duration of surgery measured in minutes between the two arms |
Countries
Spain
Outcome results
None listed