Keyhole versus open colorectal surgery in the emergency setting

A multicentre, randomised controlled trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting (LaCeS2)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38815804

Enrollment

512

Registered

2022-02-09

Start date

2022-06-13

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic versus open colorectal surgery Surgery

Interventions

LaCeS2 is a phase III, multicentre, randomised controlled superiority trial investigating the effectiveness and cost-effectiveness of keyhole (laparoscopic) colorectal emergency surgery compared to op

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
1. Quality of life measured using the Gastrointestinal Quality of Life Index (GIQLI) and the 12-Item Short Form Survey (SF-12®) at 30 days, 90 days, 6, 9 and 12 months post-operation 2. Severity of 30-day postoperative complications measured using the Clavien-Dindo Classification and the Comprehensive Complication Index (CCI) at 30 days post-operation 3. Incidence of 90-day postoperative complications and incidence of surgery-specific complications over 12 months post-operation, measured at 90 days, 6 and 12 months post-operation. The incidence of 90-day complications is defined as the number of patients with a complication occurring within 90 days post-operatively as a proportion of all randomised patients. The incidence of surgery-specific complications is calculated as the number of patients experiencing a surgery-specific complication within 6 and 12 months as a proportion of all randomised patients. 4. Incidence of intra-operative complications and incidence of conversions from laparoscopic to open surgery measured at operation. The incidence of intra-operative complications is defined as the number of patients with intra-operative complications recorded as a proportion of all randomised patients. The incidence of conversions from laparoscopic to open surgery is calculated as the number of patients experiencing a conversion as a proportion of all patients allocated to receive laparoscopic surgery. An intra-operative conversion from laparoscopic to open surgery is defined as the use of a midline laparotomy wound for any part of the colorectal dissection during the procedure. 5. 30-day postoperative mortality, re-operations and readmissions measured at 30 days post-operation: 5.1. 30-day postoperative mortality: mortality rates are defined as the number of patients that have been recorded as dead within the 30 days following surgery as a proportion of all randomised patients 5.2. 30-day postoperative re-operations: the incidence of re-operations is defined as	—

Measure

Time frame

1. Quality of life measured using the Gastrointestinal Quality of Life Index (GIQLI) and the 12-Item Short Form Survey (SF-12®) at 30 days, 90 days, 6, 9 and 12 months post-operation 2. Severity of 30-day postoperative complications measured using the Clavien-Dindo Classification and the Comprehensive Complication Index (CCI) at 30 days post-operation 3. Incidence of 90-day postoperative complications and incidence of surgery-specific complications over 12 months post-operation, measured at 90 days, 6 and 12 months post-operation. The incidence of 90-day complications is defined as the number of patients with a complication occurring within 90 days post-operatively as a proportion of all randomised patients. The incidence of surgery-specific complications is calculated as the number of patients experiencing a surgery-specific complication within 6 and 12 months as a proportion of all randomised patients. 4. Incidence of intra-operative complications and incidence of conversions from laparoscopic to open surgery measured at operation. The incidence of intra-operative complications is defined as the number of patients with intra-operative complications recorded as a proportion of all randomised patients. The incidence of conversions from laparoscopic to open surgery is calculated as the number of patients experiencing a conversion as a proportion of all patients allocated to receive laparoscopic surgery. An intra-operative conversion from laparoscopic to open surgery is defined as the use of a midline laparotomy wound for any part of the colorectal dissection during the procedure. 5. 30-day postoperative mortality, re-operations and readmissions measured at 30 days post-operation: 5.1. 30-day postoperative mortality: mortality rates are defined as the number of patients that have been recorded as dead within the 30 days following surgery as a proportion of all randomised patients 5.2. 30-day postoperative re-operations: the incidence of re-operations is defined as

—

Countries

England, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026