Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

— NOTES  

Official title:

Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549456
• Other study ID #: MD/148
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2015
• Last updated: March 22, 2017
• Start date: December 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: Islam H Metwally, M.Sc
• Phone: 01002985865
• Email: dr.islamo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• natural orifice specimen extraction
Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
• Laparoendoscopic 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 re?ection. The superior rectal artery is divided. The rectal stump then is re?ected 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 ?exure is done if needed.

Locations

Country	Name	City	State
Egypt	Oncology center Mansoura University	Mansoura	Dakahlia

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Universidade da Coruña

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Rate of conversion to classic laparoscopy or to open laparotomy.	24 hour
Primary	operative time	time taken from starting operation till patient wake up	24 hour
Primary	Operative blood loss	measured in milliliter	24 hour
Primary	Wound complications	infection-dehiscence	two week
Primary	Major intraoperative complications	bleeding -organ injury	24 hour
Primary	Major postoperative complications	leak-bleeding	two weeks
Secondary	Adequacy of lymphadenectomy	Number of lymph nodes retrieved	one month
Secondary	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.	one month
Secondary	Longitudinal safety margin	either free or infiltrated with tumor by histopathology examination.	one month
Secondary	short term oncologic outcome	incidence of local and distant outcomes and disease free survival	6 months - one year
Secondary	Functional outcome	assessing fecal incontinence using Kirwan's grading score	3 months