Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer – the GHOST-trial

Not Applicable

Conditions: C20
Malignant neoplasm of rectum

Registration Number: DRKS00013997

Lead Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients undergoing elective low anterior resection for rectal cancer
- Ability of subject to understand character and individual consequences of the clinical trial
- = 18 years of age
- Written informed consent

Exclusion Criteria

Preoperative exclusion criteria:
- BMI >30 kg/m²
- ASA >3
- Chronic renal failure (necessitating dialysis or GFR <30 ml/min)
- Immunosuppression (cortisone = 40 mg/d or equivalent; azathioprine, etc.)
- Significant cardiac disease
- Current therapeutic anticoagulation
- Liver cirrhosis (of any Child-Pugh grade)
- Ultralow rectal cancer (<4 cm ab ano, or necessitating intersphincteric resection or transanal colo-anal anastomosis)
- Participation in another intervention trial with interference of intervention and outcome of this study

Intraoperative exclusion criteria:
- Incomplete stapling rings
- Positive intraoperative air (bubble) test
- Intraoperative findings that make a loop ileostomy inevitable in the individual surgeon’s opinion (e.g. intraoperative diagnosis of liver cirrhosis, acute or chronic Ileus, intraoperative lesion of the rectum, urinary bladder, vagina, etc.)
- Multivisceral resection

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and feasibility of a ghost ileostomy compared to conventional loop ileostomy in patients undergoing elective low anterior resection for rectal cancer<br>

Secondary Outcome Measures

Name	Time	Method
1. Comprehensive Complication Index during 30 days and 6 months after index operation<br>2. Anastomotic leakage (according to the ISREC definition)<br>3. Frequency of transformation of ghost ileostomy into protective loop ileostomy<br>4. 30-day mortality<br>5. reoperations<br>6. rate of terminal ostomy<br>7. Intra-abdominal abscess<br>8. Need for interventional drainage<br>9. Completion of intended chemotherapy<br>10. QoL (EORTC QLQ-C30, CR29)<br>11. Stoma related complications<br>12. Survival<br>13. Complications after ileostomy closure<br>14. Mean length of bearing the stoma (in days)<br>15. Postoperative anorectal function 6 months after initial surgery (Wexner score)<br>16. Patients with stoma (terminal / loop) at 6 months after initial surgery