Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer (NOTES)

Mansoura University

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Procedure: natural orifice specimen extraction; Procedure: Laparoendoscopic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02549456

MD/148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Natural orifice specimen extraction

Experimental group

Description:

Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction

Treatment:

Procedure: natural orifice specimen extraction

Laparoendoscopic resection

Experimental group

Description:

Laparoscopic assisted transanal endoscopic resection of rectal cancer

Treatment:

Procedure: Laparoendoscopic resection