Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer

NCT05970133 | Recruiting

• 1 other identifier: 202301224RINB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, the investigator aims to provide the level 1 evidence for the comparison of robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the investigator hypothesize that, with the increased maneuverability of the current robotic system, robotic surgery will be a good option for patients with stage I-III colorectal cancer requiring a NOSE procedure.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Natural orifice specimen extraction; Laparoscopic surgery; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• The surgical efficiency of both NOSE procedures

  The operation time defined as the incision of wound and application of the surgical dressing

  Intraoperative hours with an average of 5 hours

Secondary Outcomes (13)

• Overall disease-free survival

  5 years

• Overall recurrence-free survival

  5 years

• Incontinence

  6 months

• Time to return work

  1 year

• Total fee and equipment fee

  3 months

Study Arms (2)

Laparoscopic surgery

EXPERIMENTAL

The patients in this group will undergo laparoscopic surgery.

Procedure: Colectomy with NOSE procedure

Robotic surgery

ACTIVE COMPARATOR

The patients in this group will undergo robotic surgery.

Procedure: Colectomy with NOSE procedure

Interventions

Colectomy with NOSE procedure PROCEDURE

The specimen will be extract from the anus.

Laparoscopic surgery; Robotic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary colon cancers located at the left sided colonic anatomic location, including distal transverse colon, colonic splenic flexure, descending colon, sigm oid descending colonic junction, sigmoid colon and upper rectum that required the mobilization of colonic splenic flexure to facilitate a curative resection and trans anal specimen extraction ;
• TNM Stage I III adenocarcinomas;
• Curative and elective surgery;
• American Society of Anesthesiology (ASA) class I to III patients;
• Age \>18 years.

You may not qualify if:

• Cecal, ascending, the proximal and middle transverse colon cancers; and the middle or lower rectal cancers;
• Emergency or palliative surgery;
• Evidence of disseminated disease or adjacent organ invasion;
• Primary tumor mass \>8 cm in diameter;
• Morbidly obese patients, that is, body mass index (BMI) ≥40 kg/m 2 ;
• Previous major surgery of upper abdomen or pelvis

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jin-Tung LIANG, MD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Jin-Tung LIANG, MD

CONTACT

886-9-72651432; jintung@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 1, 2023
• Study Start: April 7, 2023
• Primary Completion: April 6, 2025
• Study Completion: October 6, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TW (1)