Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer
Conditions
Keywords
hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
Brief summary
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe
Detailed description
Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry
Interventions
PROCEDURElaparoscopic ileocecus-sparing right hemicolectomy
The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients suitable for curative surgery 18-75years old 2. ASA grade I-III 3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery); 5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis. 6. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm. 7. Informed consent
Exclusion criteria
1. Simultaneous or metachronous multiple primary colorectal cancer; 2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. 3. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery. 4. Distant metastasis. 5. History of any other malignant tumor in recent 5 years. 6. Patients need emergency operation. 7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). 8. Informed consent refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | up to 90 days after surgery | Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded |
| 1-year local recurrence | 7 days after surgery | rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of harvested lymph nodes | up to 1 week after surgery | Number of harvested Lymph nodes according to the pathological report |
| R0 resection | up to 1 week after surgery | Rate of resection without any affected margins during the surgical procedure according to the pathological report |
| Conversion to conventional right hemicolectomy | 1 day of surgery | the rate of conversion to conventional right hemicolectomy |
| 3-year disease free survival | 3 years | the time from enrollment until disease relapse or death from any cause 3 years after surgery |
| Specimen morphometry | within 30 days | The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length |
| Time to first flatus after surgery | up to 7 days after surgery | days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery |
Countries
China
Outcome results
None listed