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Completed

NCT Number: NCT04265417

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

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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Natural Orifice Specimen Extraction Surgery Neoplasms Neoplasms by Site Rectal Diseases Robotic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Assisted Rectal Cancer Resection Alone

Procedure

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

Procedure

participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.

Primary outcomes

  1. Overall survival

    Time frame: Up to 36 months

    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

  2. Disease-free survival

    Time frame: Up to 36 months

    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

Secondary outcomes

  1. Operation time

    Time frame: 1 day

    To determine the differences between NOSE group and RARC group

  2. Estimated intraoperative blood loss

    Time frame: 1 day

    To determine the differences between NOSE group and RARC group

  3. Postoperative hospital stay

    Time frame: 30 days

    To determine the surgical and patients burdern differences between NOSE group and RARC group

  4. Postoperative visual analogue scale scale on day 1

    Time frame: 1 day

    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.

  5. Time to pass flatus

    Time frame: 30 days

    To determine the surgical differences between NOSE group and RARC group

  6. Hospitalization costs

    Time frame: 30 day

    to determine the patients burden differences between NOSE group and RARC group

  7. Specimen length

    Time frame: 30 day

    To determine the surgical differences between NOSE group and RARC group

  8. Proximal margin

    Time frame: 30 day

    To determine the pathological differences between NOSE group and RARC group

  9. Distal margin

    Time frame: 30 days

    To determine the pathological differences between NOSE group and RARC group

  10. Histological differentiation

    Time frame: 30 days

    To determine the pathological differences between NOSE group and RARC group

  11. Number of lymph nodes harvested

    Time frame: 30 days

    To determine the pathological differences between NOSE group and RARC group

  12. Postoperative white blood cell count

    Time frame: 30 days

    To determine the surgical stress response differences NOSE group and RARC group

  13. Postoperative procalcitonin

    Time frame: 30 days

    To determine the surgical stress response differences NOSE group and RARC group

  14. Postoperative C-reactive protein

    Time frame: 30 days

    To determine the surgical stress response differences NOSE group and RARC group

Sponsors and collaborators

Lead sponsor

Taiyuan Li

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2020
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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