Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery (NOSES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Surgery
• Intervention / Treatment: Procedure: Natural Orifice Specimen Extraction (NOSE); Procedure: Traditional specimen extraction

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
• Study Contact Backup: Name: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Irccs Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
      • Contact: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with low rectal cancer to the English National Low Rectal Cancer Development Programme (LOREC) who underwent low rectal resection with Total Mesorectal Excision (TME)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Natural Orifice Specimen Extraction (NOSE); Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)	Procedure: Natural Orifice Specimen Extraction (NOSE); 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	Procedure: Traditional specimen extraction; Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid rescue	Difference in the proportion of patients requiring opioid rescue during the hospitalization	From the date of surgery to the date of discharge
Postoperative pain	The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)	72 hours after surgery
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
Incisional hernia	The rate difference of six-month incisional hernia	6 months after surgery
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Huamanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Rectal Cancer; Natural Orifice Specimen Extraction; Propensity score matched
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CHR1-101-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No