Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma

Chongqing Medical University

Status: Unknown

Conditions: Laparoscopic Surgery

Treatments: Procedure: conventional laparoscopic surgery; Procedure: gasless single-port laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03318185

2017140

Details and patient eligibility

About

This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.

Full description

The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.

Exclusion criteria

• Neoadjuvant therapy;Surgical contraindication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

gasless single-port laparoscopic surgery

Experimental group

Description:

radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.

Treatment:

Procedure: gasless single-port laparoscopic surgery

conventional laparoscopic surgery

Sham Comparator group

Description:

radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.

Treatment:

Procedure: conventional laparoscopic surgery