Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

NCT ID: NCT06362902

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-09-01

Brief Summary

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The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.

Detailed Description

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This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.

Conditions

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Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction

STEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision.

STEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler.

STEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision.

Group Type EXPERIMENTAL

Laparoscopic right hemicolectomy with transrectal specimen extraction

Intervention Type PROCEDURE

Laparoscopic right hemicolectomy with transrectal specimen extraction

Interventions

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Laparoscopic right hemicolectomy with transrectal specimen extraction

Laparoscopic right hemicolectomy with transrectal specimen extraction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Biopsy proven colon carcinoma;
2. Imaging diagnosis of T1-3 colon cancer;
3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
4. Maximal tumor diameter ≤5 cm;
5. Body mass index (BMI) ≤30 kg/m2;
6. Written informed consent;

Exclusion Criteria

1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, China

OTHER

Sponsor Role lead

Responsible Party

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Haitao Zhou

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haitao Zhou, M.D.

Role: STUDY_CHAIR

National Cancer Center, China

Locations

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National Cancer Center

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zheng Xu, M.D.

Role: CONTACT

+8618800157037

Yueyang Zhang, M.D.

Role: CONTACT

+8613552910035

Facility Contacts

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Haitao Zhou, M.D.

Role: primary

+8613381167333

Yueyang Zhang, M.D.

Role: backup

+8613552910035

Other Identifiers

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NOSES-VIII B

Identifier Type: -

Identifier Source: org_study_id

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