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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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gasless single-port laparoscopic surgery

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

Group Type EXPERIMENTAL

gasless single-port laparoscopic surgery

Intervention Type PROCEDURE

The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.

conventional laparoscopic surgery

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

Group Type SHAM_COMPARATOR

conventional laparoscopic surgery

Intervention Type PROCEDURE

The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.

Interventions

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gasless single-port laparoscopic surgery

The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.

Intervention Type PROCEDURE

conventional laparoscopic surgery

The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR