Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery

NCT ID: NCT06326892

Last Updated: 2024-06-26

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

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-10-15

Brief Summary

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This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.

Detailed Description

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Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).

Conditions

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Rectal Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Natural Orifice Specimen Extraction (NOSE)

Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)

Natural Orifice Specimen Extraction (NOSE)

Intervention Type PROCEDURE

Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)

Controls

Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction

Traditional specimen extraction

Intervention Type PROCEDURE

Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision

Interventions

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Natural Orifice Specimen Extraction (NOSE)

Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)

Intervention Type PROCEDURE

Traditional specimen extraction

Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023
* Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC)

Exclusion Criteria

* Patients undergoing non-restorative procedures
* Patients undergoing immediate or delayed handsewn coloanal anastomosis
* Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery
* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Huamanitas Research Hospital

Locations

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IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Annalisa Maroli, PhD

Role: CONTACT

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: CONTACT

02 8224 4623 ext. 0039

Facility Contacts

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Annalisa Maroli, PhD

Role: primary

02 8224 7776 ext. 0039

Stefano De Zanet, MS

Role: backup

02 8224 4623 ext. 0039

Other Identifiers

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CHR1-101-2024

Identifier Type: -

Identifier Source: org_study_id

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