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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
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.
Oncology center Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGFeasibility
Rate of conversion to classic laparoscopy or to open laparotomy.
Time frame: 24 hour
operative time
time taken from starting operation till patient wake up
Time frame: 24 hour
Operative blood loss
measured in milliliter
Time frame: 24 hour
Wound complications
infection-dehiscence
Time frame: two week
Major intraoperative complications
bleeding -organ injury
Time frame: 24 hour
Major postoperative complications
leak-bleeding
Time frame: two weeks
Adequacy of lymphadenectomy
Number of lymph nodes retrieved
Time frame: one month
Grading of quality and completeness of mesorectal excision
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.
Time frame: one month
Longitudinal safety margin
either free or infiltrated with tumor by histopathology examination.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: one month
short term oncologic outcome
incidence of local and distant outcomes and disease free survival
Time frame: 6 months - one year
Functional outcome
assessing fecal incontinence using Kirwan's grading score
Time frame: 3 months