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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013997

Enrollment

Registered

2018-04-09

Start date

2018-05-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C20

Interventions

Group 1: Ghost ileostomy fashioned at the end of the operation Group 2: Conventional protective loop ileostomy fashioned at the end of the operation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactFelix Hüttner

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

felix.huettner@med.uni-heidelberg.de06221-566986

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026