Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

Phase 3

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Conventional laparoscopic surgery; Procedure: transrectal specimen extraction

• Registration Number: NCT02635503
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Detailed Description

Further study details as provided by Chinese Academy of Medical Sciences.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

• 18 years < age < 80 years
• Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
• Pathological rectosigmoid adenocarcinoma
• Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
• Tumor size of 6 cm or less;
• Eastern Cooperative Oncology Group (ECOG) score is 0-1
• American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
• Informed consent

Exclusion Criteria

• Body mass index (BMI) >30 kg/m2
• Pregnant woman or lactating woman
• Severe mental disease
• Previous abdominal surgery
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
• Requirement of simultaneous surgery for other disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional laparoscopic surgery	Conventional laparoscopic surgery	Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
transrectal specimen extraction	transrectal specimen extraction	Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.

Primary Outcome Measures

Name	Time	Method
Early morbidity rate	30 days	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Duration of the intervention	1 day	Duration of surgery.
Peritoneal bacterial contamination	1 day	Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
Pain score	14 days	Recording of the needed analgesia guided by pain score
3-year disease free survival rate	3 years	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
5-year overall survival rate	5 years	A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Plasma levels of several cytokines after colorectal cancer surgery	7 days	We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College; 🇨🇳 Beijing, Beijing, China