Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
1 other identifier
interventional
200
1 country
1
Brief Summary
Radical surgery for rectal cancer has evolved from the initial concept of total mesorctal excision (TME) to the wide application of laparoscopic surgery in the radical treatment of rectal cancer. After 30 years' rapid development, nowdays laparoscopic TME surgery for rectal cancer has become the first choice for those patients with rectal cancer. However, the auxiliary incision of the abdominal wall which is used to remove tumor specimens is contrary to the current concept of minimally invasive surgery. Avoiding abdominal wall incisions has become a common appeal of gastrointestinal surgeons and patients with rectal cancer. Natural orififice specimen extraction surgery (NOSES) can solve the problem of abdominal wall auxiliary incision, which complete rectal cancer radical resection and gastrointestinal reconstruction under the full laparoscopic. The specimens are taken out through the natural orifice (rectum or vagina) without an auxiliary incision, which is more in line with minimally invasive practice and easier to operate. Researching on the progress of laparoscopic radical resection of rectal cancer in NOSES aims to provide a certain reference for this operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Jan 2018
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedSeptember 22, 2020
September 1, 2020
4.2 years
September 16, 2020
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications
pulmonary infection，Urinary tract infection，anal function，intestinal obstruction，Anastomotic bleeding，etc.
One month after operation
Secondary Outcomes (1)
survival
3-year and 5-year after operation
Study Arms (2)
Natural Orifice Specimen Extraction Surgery
EXPERIMENTALConventional laparoscopy
SHAM COMPARATORInterventions
NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes. Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xu Fujian
Study Record Dates
First Submitted
September 16, 2020
First Posted
September 22, 2020
Study Start
January 1, 2018
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share