Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

April 8, 2024 updated by: Haitao Zhou, National Cancer Center, China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction
Laparoscopic right hemicolectomy with transrectal specimen extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of postoperative complications
Time Frame: up to 30 days
The rate of postoperative complications = patients with any postoperative complications/all cases.
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: up to 1 days
Operating time = The Operative time was defined as the time first skin incision was made to final skin closure
up to 1 days
Estimated blood loss
Time Frame: up to 1 days
Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g)
up to 1 days
The time of first flatus
Time Frame: up to 5 days
The time of first flatus = The time of first flatus reported by patients
up to 5 days
Postoperative hospitalization
Time Frame: up to 30 days
Postoperative hospitalization = the number of nights from surgery to discharge
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, China

Investigators

  • Study Chair: Haitao Zhou, M.D., National Cancer Center, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOSES-VIII B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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