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

Study Overview
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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.

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.

Official Title
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Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma

Conditions
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Laparoscopic Surgery

Intervention / Treatment
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* Procedure: gasless single-port laparoscopic surgery
* Procedure: conventional laparoscopic surgery


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gasless single-port laparoscopic surgery<br>radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery. | Procedure: gasless single-port laparoscopic surgery<br>* The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.<br>|
| Sham Comparator: conventional laparoscopic surgery<br>radical resection of rectal carcinoma is performed by conventional laparoscopic surgery. | Procedure: conventional laparoscopic surgery<br>* The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen. | Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over. | 
| Immunologic function | Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers. | Change from baseline CD4/CD8 ratio 7 days after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Measure the operation time, which will be compared with comparator. | at 1 day | 
| Postoperative pain | Measure the postoperative pain after operation by numerical rating scale(NRS), which will be compared with comparator. | 72 hours after operation | 
| Bowel function | Measure the restoration of bowel function after operation, which will be compared with comparator.The bowel function was evaluated by first flatus. | up to 1 week after operation | 
| Number of the lymph node dissection | Measure the number of the regional lymph node dissection after operation, which will be compared with comparator. | at 1 week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gasless single-port laparoscopic surgery;rectal carcinoma