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NCT Number: NCT04037956

Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.

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Key information

Conditions

Tubeless NOSES Rectosigmoid Cancers Traditional Laparoscopic Radical Resection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed Rectosigmoid Cancers
  • Clinical stage at T 1-3 N0-2 M0
  • Tumors on peritoneal reflection，Tumor size is no more than 3 cm
  • Eastern Cooperative Oncology Group (ECOG) scale is 0-2
  • American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
  • BMI ≤ 30 kg/m2
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.

Exclusion criteria

  • Heart, lung, liver or renal or any organ function that are intolerance for surgery
  • History of treated colorectal malignant disease
  • Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
  • Subjects with previous malignancies
  • History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
  • Treatment with any other clinical trial within 28 days prior to randomization
  • History of severe mentally disease
  • pregnant or lactating women
  • The researchers believe that the patients are unsuitable to participate in the researchers with other cases.

Treatment and study plan

Tubeless NOSES

Procedure

The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).

traditional laparoscopic radical resection

Procedure

The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.

Primary outcomes

  1. 3-year disease free survival rate

    Time frame: 36 months after surgery

Secondary outcomes

  1. 5-year overall survival rate

    Time frame: 60 months after surgery

  2. Incidence of postoperative complications

    Time frame: 1 month after surgery

    All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.

  3. the functional outcome of defecation

    Time frame: 60 months after surgery

    Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).

  4. the operation time

    Time frame: in the perioperative period

    The descriptive unit would be minute (min).

  5. the blood loss during the operation

    Time frame: in the perioperative period

    The descriptive unit would be millilitre (ml)

  6. Postoperative recovery of intestinal peristalsis

    Time frame: in the perioperative period

    The descriptive unit would be hour (h).

  7. Pain score

    Time frame: in the perioperative period

    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).

  8. number of cases converted to laparotomy

    Time frame: in the perioperative period

    The procedure for cases who underwent traditional laparoscopic radical resection for those who cannot be done with traditional laparoscopic radical resection or Tubless NOSES and convert to laparotomy as a result，these should be recorded and compared within two experimental arms.

  9. the mean postoperative hospitalization day

    Time frame: in the perioperative period

    The descriptive unit would be day (d).

Study contacts

Contact information is provided by the study sponsor or research team.

Jinxin Lin, MD，PHD

CONTACT

[email protected]

86-18998815200

Yanxin Luo, MD，PHD

CONTACT

[email protected]

86-13826190263

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)

Acronym: CORNER

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Jul 30, 2019
Registry last updated
Mar 31, 2022

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.