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NCT Number: NCT03151733

Single Incision Laparoscopic Colorectal Surgery

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

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Key information

Conditions

Laparoscopic Colorectal Surgery Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ruijin hospital North

Shanghai, Shanghai Municipality, 201821, China

About this study

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years < age < 80 years
  • Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
  • Pathological colorectal carcinoma
  • Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
  • Tumor size of 5 cm or less
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

Exclusion criteria

  • Body mass index (BMI) >30 kg/m2
  • The lower border of the tumor is located distal to the peritoneal reflection
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Previous abdominal surgery（except appendectomy and cholecystotomy）
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Treatment and study plan

single incision laparoscopic surgery

Procedure

Patients undergo single incision laparoscopic surgery

Conventional Laparoscopic Surgery

Procedure

Patients undergo conventional laparoscopic surgery

Primary outcomes

  1. Early morbidity rate

    Time frame: 30 days

    morbidity rate 30 days after surgery

Secondary outcomes

  1. Operative time

    Time frame: intraoperative

    Operative time（minutes）

  2. Intraoperative blood loss

    Time frame: intraoperative

    Estimated blood loss（milliliters，ml）

  3. Incision length

    Time frame: intraoperative

    Incision length（centimeters，cm）

  4. Lymph node detection

    Time frame: 14 days after surgery

    Lymph nodes harvested（numbers）

  5. Incisal margin

    Time frame: 14 days after surgery

    Length of proximal and distal margin （centimeters，cm）

  6. Tumor size

    Time frame: 14 days after surgery

    The diameter of tumors（centimeters，cm）

  7. Length of stay

    Time frame: 1-14 days after surgery

    Duration of hospital stay（days after surgery）

  8. Postoperative recovery course

    Time frame: 1-14 days after surgery

    Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

  9. Pain score

    Time frame: 1-3 days after surgery

    Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge

  10. 3-year disease free survival rate

    Time frame: 36 months after surgery

    3-year disease free survival rate

  11. 5-year overall survival rate

    Time frame: 60 months after surgery

    5-year overall survival rate

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Acronym: SILCS

Important dates

Study start
2017
Primary completion
2019
Study completion
2024
First posted
May 12, 2017
Registry last updated
Dec 10, 2024

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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