The role of 3D laparoscopic rectal surgery: a randomised controlled trial

Not Applicable

Completed

• Conditions: Rectal adenocarcinoma; Cancer

• Registration Number: ISRCTN59485808
• Lead Sponsor: Yeovil District Hospital NHS Foundation Trust

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30656453 results (added 13/03/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31567928/ Factors predicting operative difficulty (added 10/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Study Completion: 2018-04-30
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Patients diagnosed with adenocarcinoma of the rectum (<15cm from anal verge as measured by staging MRI )
2. Scheduled to undergo elective laparoscopic TME/ partial mesorectal excision surgery with curative intent, with or without neo-adjuvant treatment and with or without defunctioning stoma formation
3. Written informed patient consent

Exclusion Criteria

1. History of inflammatory bowel disease
2. Patients requiring abdomino-perineal excision or surgery without anastomosis
3. Advanced tumours involving adjacent organs (TNM5 T4aNxMx)
4. Surgery performed with palliative intent or under unplanned/emergency settings
5. Previous treatment (radiotherapy/abdominopelvic surgery) for endometrial, ovarian, prostate, bladder (TURBT ok), anal or vaginal cancer
6. Patient or surgeon refusal to enter study or accept randomisation result

Study & Design

• Study Type: Interventional
• Study Design: Not specified