Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer

NCT ID: NCT04559087

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-04-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Natural Orifice Specimen Extraction Surgery

Group Type: EXPERIMENTAL

Laparoscopic Surgery

Intervention Type: PROCEDURE

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.

Conventional laparoscopy

Group Type: SHAM_COMPARATOR

Laparoscopic Surgery

Intervention Type: PROCEDURE

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.

Interventions

Laparoscopic Surgery

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.

Intervention Type: PROCEDURE

Other Intervention Names

Conventional Laparoscopic Surgery

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (≤T3); (4) tumor circumference <5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.

Exclusion Criteria:

• The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) > 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score ≥ IV; (7) active period of infection; (8) blood neutrophils <3 × 109/L.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zunyi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Xu Fujian

Xu Fujian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiliated hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fujian Xu, Master

Role: CONTACT

911583440@qq.com

+8615895864837

Ming Xie, MD

Role: CONTACT

2581303091@qq.com

+8615519202000

Facility Contacts

Ming Xie, MD

Role: primary

2581303091@qq.com

+8615519202000

Other Identifiers

WA2020RW12

Identifier Type: -

Identifier Source: org_study_id