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

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265417
• Other study ID #: RARN
• Status: Completed
• Start date: January 6, 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. T stage 1-3;

2. aged between 18 to 75;

3. the tumor margin is at least 4 cm from the anus;

4. body mass index =30kg/m2;

5. no distant metastases; (6)tumor size=5cm.

Exclusion Criteria:

1. emergency surgery for intestinal obstruction or massive bleeding;

2. history of abdominal or pelvic surgery.

Related Conditions & MeSH terms

• Natural Orifice Specimen Extraction Surgery
• Rectal Neoplasms
• Robotic Surgery

Intervention

Procedure:
• Robotic Assisted Rectal Cancer Resection Alone
participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.
• Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction
participants in this group underwent robotic rectal cancer resection,the specimens were extractd through anus and vagina.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taiyuan Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Operation time	To determine the differences between NOSE group and RARC group	1 day
Secondary	Estimated intraoperative blood loss	To determine the differences between NOSE group and RARC group	1 day
Secondary	Postoperative hospital stay	To determine the surgical and patients burdern differences between NOSE group and RARC group	30 days
Secondary	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
Secondary	Time to pass flatus	To determine the surgical differences between NOSE group and RARC group	30 days
Secondary	Hospitalization costs	to determine the patients burden differences between NOSE group and RARC group	30 day
Secondary	Specimen length	To determine the surgical differences between NOSE group and RARC group	30 day
Secondary	Proximal margin	To determine the pathological differences between NOSE group and RARC group	30 day
Secondary	Distal margin	To determine the pathological differences between NOSE group and RARC group	30 days
Secondary	Histological differentiation	To determine the pathological differences between NOSE group and RARC group	30 days
Secondary	Number of lymph nodes harvested	To determine the pathological differences between NOSE group and RARC group	30 days
Secondary	Postoperative white blood cell count	To determine the surgical stress response differences NOSE group and RARC group	30 days
Secondary	Postoperative procalcitonin	To determine the surgical stress response differences NOSE group and RARC group	30 days
Secondary	Postoperative C-reactive protein	To determine the surgical stress response differences NOSE group and RARC group	30 days