Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery

Surgery Clinical Trial

— NOSES  

Official title:

Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326892
• Other study ID #: CHR1-101-2024
• Status: Recruiting
• Start date: July 31, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2024
• Source: Istituto Clinico Humanitas
• Contact: Annalisa Maroli, PhD
• Phone: 02 8224 7776
• Email: colorapp[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 15, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Procedure:
• Natural Orifice Specimen Extraction (NOSE)
Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)
• Traditional specimen extraction
Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision

Locations

Country	Name	City	State
Italy	IRCCS Humanitas Research Hospital	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infections (SSI)	Rate difference of 30-day Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC) [Ref]- between the study cohorts.	30 days after surgery
Secondary	Opioid rescue	Difference in the proportion of patients requiring opioid rescue during the hospitalization	From the date of surgery to the date of discharge
Secondary	Postoperative pain	The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)	72 hours after surgery
Secondary	Postoperative ileus	Rate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days)	30 days after surgery
Secondary	Incisional hernia	The rate difference of six-month incisional hernia	6 months after surgery
Secondary	Overall postoperative complications	The rate difference of overall 30-day postoperative complications, classified according to the Clavien-Dindo scale [ranging from 0 (no complications) to 5 (complications leading to death)]	30 days after surgery