Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction

Study Overview
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Brief Summary
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Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question.

Detailed Description
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Robotic rectal cancer resection with natural orifice extraction is a recently developed minimally invasive surgery for patients with rectal cancer. However, it's safety and feasibility remain undiscussed and controversial. This study reported the clinical outcomes and prognostic factors of robotic assisted rectal cancer resection alone vs. robotic rectal cancer resection with natural orifice extraction to discuss aforementioned question. From January 2015 to November 2016, a consecutive wave of 49 patients underwent robotic rectal cancer resection with natural orifice extraction and 49 matched patients underwent conventional robotic assisted rectal cancer resection were systematically analyzed in this study.

Official Title
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Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction

Conditions
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Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery

Intervention / Treatment
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* Procedure: Robotic Assisted Rectal Cancer Resection Alone
* Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T stage 1-3; aged between 18 to 75; the tumor margin is at least 4 cm from the anus; body mass index ≤30kg/m2; no distant metastases； (6）tumor size≤5cm. Exclusion Criteria: emergency surgery for intestinal obstruction or massive bleeding; history of abdominal or pelvic surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RARC group<br>Participants in this group underwent robotic assisted rectal cancer resection | Procedure: Robotic Assisted Rectal Cancer Resection Alone<br>* participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.<br>|
| NOSE group<br>Participants in this group underwent robotic rectal cancer resection assisted rectal with natural orifice extraction | Procedure: Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction<br>* participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | To determine the survival differences between NOSE group and RARC group. Overall survival is defined as the time from surgery to death from any causes | Up to 36 months | 
| Disease-free survival | To determine the survival differences between NOSE group and RARC group. Disease-free survival is defined as the time from surgery to local or distant recurrence | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | To determine the differences between NOSE group and RARC group | 1 day | 
| Estimated intraoperative blood loss | To determine the differences between NOSE group and RARC group | 1 day | 
| Postoperative hospital stay | To determine the surgical and patients burdern differences between NOSE group and RARC group | 30 days | 
| Postoperative visual analogue scale scale on day 1 | To determine the surgical differences between NOSE group and RARC group. Maxium sacle is 10, miniun scale is 0. 0 represents no pain. 10 represents maximun pain. | 1 day | 
| Time to pass flatus | To determine the surgical differences between NOSE group and RARC group | 30 days | 
| Hospitalization costs | to determine the patients burden differences between NOSE group and RARC group | 30 day | 
| Specimen length | To determine the surgical differences between NOSE group and RARC group | 30 day | 
| Proximal margin | To determine the pathological differences between NOSE group and RARC group | 30 day | 
| Distal margin | To determine the pathological differences between NOSE group and RARC group | 30 days | 
| Histological differentiation | To determine the pathological differences between NOSE group and RARC group | 30 days | 
| Number of lymph nodes harvested | To determine the pathological differences between NOSE group and RARC group | 30 days | 
| Postoperative white blood cell count | To determine the surgical stress response differences NOSE group and RARC group | 30 days | 
| Postoperative procalcitonin | To determine the surgical stress response differences NOSE group and RARC group | 30 days | 
| Postoperative C-reactive protein | To determine the surgical stress response differences NOSE group and RARC group | 30 days |