Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery

Recruiting

• Conditions: Rectal Cancer; Surgery
• Interventions: Procedure: Natural Orifice Specimen Extraction (NOSE); Procedure: Traditional specimen extraction

• Registration Number: NCT06326892
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

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 Timeline

• Study Start: 2023-07-31
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-22
• Primary Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natural Orifice Specimen Extraction (NOSE)	Natural Orifice Specimen Extraction (NOSE)	Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)
Controls	Traditional specimen extraction	Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction

Primary Outcome Measures

Name	Time	Method
Surgical Site Infections (SSI)	30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Incisional hernia	6 months after surgery	The rate difference of six-month incisional hernia
Postoperative pain	72 hours after surgery	The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)
Postoperative ileus	30 days after surgery	Rate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days)
Overall postoperative complications	30 days after surgery	The rate difference of overall 30-day postoperative complications, classified according to the Clavien-Dindo scale \[ranging from 0 (no complications) to 5 (complications leading to death)\]
Opioid rescue	From the date of surgery to the date of discharge	Difference in the proportion of patients requiring opioid rescue during the hospitalization

Trial Locations

Locations (1)

IRCCS Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy