Keyhole versus open colorectal surgery in the emergency setting

Not Applicable

• Conditions: aparoscopic versus open colorectal surgery; Surgery

• Registration Number: ISRCTN38815804
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-09
• Last Update Posted: 19 August 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

1. Aged =18 years
2. Diagnosis of acute colorectal pathology requiring resectional surgery (for example; acute diverticular disease, inflammatory bowel disease, large bowel obstruction and colonic perforation) confirmed radiologically and/or endoscopically. A colorectal resection will be defined as surgery from the caecum to the anus
3. Urgency of operation defined as per National Confidential Enquiry into Patient Outcome and Death (NCEPOD) guidelines as urgent: intervention for acute onset or clinical deterioration of potentially life-threatening conditions, for those conditions that may threaten the survival of limb or organ, for fixation of many fractures and for relief of pain or other distressing symptoms. Normally within hours of the decision to operate, subdivided into NELA categories of 2a (approx. 2-6 hours) or 2b (approx. 6-18 hours).
4. Suitable for laparoscopic and open surgery
5. Informed written consent obtained
6. Able and willing to comply with the terms of the protocol including quality of life questionnaires

Exclusion Criteria

1. Acute non-colorectal pathology (for example; adhesional small bowel obstruction, appendicitis, peptic ulcer disease)
2. Hand-assisted laparoscopic surgery using a hand port
3. Laparoscopy and peritoneal lavage alone for colorectal pathology
4. Insertion of an endoscopic stent followed by laparoscopic resection for obstructing colorectal pathology
5. Patients undergoing emergency surgery for complications of elective colorectal operations
6. Pregnancy
7. Pre-existing cognitive impairment affecting the patient’s capacity to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of 30-day postoperative complications, defined as the number of patients with a complication (of any grade) occurring within 30 days of surgery as a proportion of all randomised patients