The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer

NCT ID: NCT06753968

Last Updated: 2024-12-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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This study is a retrospective clinical study. We reviewed collected data from all patients who underwent laparoscopic curative resection for stage I-III right-sided colon cancer between January 2018 and January 2023. A total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the NOSES group. To establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (TLRH) during the same period were selected. The purpose of this study is to investigate the short-term and long-term outcomes between NOSES and TLRH. The hypothesis is that NOSES could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with TLRH.

Conditions

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Colon Cancer

Keywords

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colon cancer totallly laparoscopic right hemicolectomy natural orifice specimen extraction surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

The NOSES group employs two distinct methods for specimen extraction, both of which have been thoroughly outlined in previous studies. The first method, transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. The second method, transrectal extraction, similarly begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Group Type EXPERIMENTAL

Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Intervention Type PROCEDURE

Transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. Similarly, transrectal extraction begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Totally Laparoscopic Right Hemicolectomy (TLRH)

Totally Laparoscopic Right Hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, enhances the benefits of minimally invasive surgery In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

Group Type ACTIVE_COMPARATOR

Totally laparoscopic right hemicolectomy (TLRH)

Intervention Type PROCEDURE

Totally laparoscopic right hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, further enhances the benefits of minimally invasive surgery. In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

Interventions

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Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. Similarly, transrectal extraction begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Intervention Type PROCEDURE

Totally laparoscopic right hemicolectomy (TLRH)

Totally laparoscopic right hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, further enhances the benefits of minimally invasive surgery. In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

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. 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

80 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

Professor Haitao Zhou

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center, Beijing, Beijing 100000

Beijing, , China

Site Status

Countries

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China

References

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Li XW, Wang CY, Zhang JJ, Ge Z, Lin XH, Hu JH. Short-term efficacy of transvaginal specimen extraction for right colon cancer based on propensity score matching: A retrospective cohort study. Int J Surg. 2019 Dec;72:102-108. doi: 10.1016/j.ijsu.2019.07.025. Epub 2019 Jul 27.

Reference Type RESULT
PMID: 31362128 (View on PubMed)

Other Identifiers

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NOSES for right hemicolectomy

Identifier Type: -

Identifier Source: org_study_id