Colorectal Cancer
Conditions
Keywords
natural orifice surgery, natural orifice specimen extraction, taTME
Brief summary
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
Detailed description
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
Interventions
PROCEDUREnatural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
PROCEDURELaparoendoscopic resection
Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length. Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.
Sponsors
Universidade da Coruña
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Medically fit patient. 2. Non metastatic pathologically proven sigmoid colon cancer. 3. Non metastatic pathologically proven rectal cancer. 4. Patient continent for stool.
Exclusion criteria
1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5. 2. Patients with cardiac or chest problems that cannot withstand insufflation. 3. Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation). 4. Obstructed or perforated cancer. 5. Patients with metastatic colorectal cancer. 6. Incontinent patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major postoperative complications | two weeks | leak-bleeding |
| Feasibility | 24 hour | Rate of conversion to classic laparoscopy or to open laparotomy. |
| operative time | 24 hour | time taken from starting operation till patient wake up |
| Operative blood loss | 24 hour | measured in milliliter |
| Wound complications | two week | infection-dehiscence |
| Major intraoperative complications | 24 hour | bleeding -organ injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| short term oncologic outcome | 6 months - one year | incidence of local and distant outcomes and disease free survival |
| Adequacy of lymphadenectomy | one month | Number of lymph nodes retrieved |
| Grading of quality and completeness of mesorectal excision | one month | It is a composite outcome where result will appear as either complete, near complete or incomplete. Criteria in (shape, coning, presence of defects and circumferential safety margin) will be integrated to categorize it. |
| Longitudinal safety margin | one month | either free or infiltrated with tumor by histopathology examination. |
| Functional outcome | 3 months | assessing fecal incontinence using Kirwan's grading score |
Countries
Egypt
Contacts
Primary ContactIslam H Metwally, M.Sc
Outcome results
None listed