Colon Cancer
Conditions
Keywords
Colon cancer, Laparoscopic Right Hemicolectomy, Natural orifice specimen extraction surgery
Brief summary
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.
Detailed description
This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.
Interventions
PROCEDURELaparoscopic right hemicolectomy with transrectal specimen extraction
Laparoscopic right hemicolectomy with transrectal specimen extraction
Sponsors
National Cancer Center, China
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. Biopsy proven colon carcinoma; 2. Imaging diagnosis of T1-3 colon cancer; 3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure; 4. Maximal tumor diameter ≤5 cm; 5. Body mass index (BMI) ≤30 kg/m2; 6. Written informed consent;
Exclusion criteria
1. Complete intestinal obstruction; 2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment); 3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation; 4. Pregnancy or breastfeeding; 5. Alcohol abuse or drug addiction; 6. Concurrent uncontrolled medical condition;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of postoperative complications | up to 30 days | The rate of postoperative complications = patients with any postoperative complications/all cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | up to 1 days | Operating time = The Operative time was defined as the time first skin incision was made to final skin closure |
| Estimated blood loss | up to 1 days | Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g) |
| The time of first flatus | up to 5 days | The time of first flatus = The time of first flatus reported by patients |
| Postoperative hospitalization | up to 30 days | Postoperative hospitalization = the number of nights from surgery to discharge |
Countries
China
Contacts
Primary ContactZheng Xu, M.D.
Backup ContactYueyang Zhang, M.D.
Outcome results
None listed