Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections

NCT04573075 | Completed

• 1 other identifier: GI_observational_01_20
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

A Ghost Ileostomy (GI) as an alternative to a diverting protective Loop Ileostomy (LI) after colorectal resection is offered the patients at risk preoperatively. A GI is only applied in cases, who would receive a LI otherwise.

Conditions

Colorectal Surgery

Keywords

ghost ileostomy; loop ileostomy; colorectal resection

Outcome Measures

Primary Outcomes (1)

• number of protective loop ileostomies avoided by the ghost stoma

  The number of ghost ileostomies that did not need to be transformed to a loop ileostomy is counted.

  through study completion, an average of one year

Secondary Outcomes (1)

• Morbidity and Mortality after ghost ileostomy compared to the other groups

  through study completion, an average of one year

Other Outcomes (3)

• health care expenses

  through study completion, an average of one year

• participants' satisfaction with the experimental intervention

  through study completion, an average of one year

• operating time needed in cases of a ghost ileostomy

  through study completion, an average of one year

Study Arms (3)

no outlet

OTHER

no outlet is used after colorectal resection and forming of a primary anastomosis

Procedure: no outlet

loop ileostomy

ACTIVE COMPARATOR

loop ileostomy is applied after colorectal resection and forming of a primary anastomosis

Procedure: loop ileostomy

ghost ileostomy

EXPERIMENTAL

ghost ileostomy or ghost stoma (synonyms) is performed after colorectal resection and forming of a primary anastomosis

Procedure: Ghost ileostomy

Interventions

Ghost ileostomy PROCEDURE

a loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy

Also known as: Ghost stoma

ghost ileostomy

loop ileostomy PROCEDURE

a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis

loop ileostomy

no outlet PROCEDURE

no further intervention is used after colorectal resection and forming of a primary anastomosis

no outlet

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: participants eligibility is based in self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• Evangelisches Klinikum Köln Weyertal gGmbH: lead
• University of Cologne: collaborator

Study Sites (1)

Evangelisches Klinikum Koeln Weyertal

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (4)

• McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.

  PMID: 25703524 BACKGROUND

• Ihnat P, Gunkova P, Peteja M, Vavra P, Pelikan A, Zonca P. Diverting ileostomy in laparoscopic rectal cancer surgery: high price of protection. Surg Endosc. 2016 Nov;30(11):4809-4816. doi: 10.1007/s00464-016-4811-3. Epub 2016 Feb 22.

  PMID: 26902615 BACKGROUND

• Sacchi M, Legge PD, Picozzi P, Papa F, Giovanni CL, Greco L. Virtual ileostomy following TME and primary sphincter-saving reconstruction for rectal cancer. Hepatogastroenterology. 2007 Sep;54(78):1676-8.

  PMID: 18019692 BACKGROUND

• Hernandez AV, Otten J, Christ H, Ulrici C, Piriyev E, Ludwig S, Rudroff C. Ghost Ileostomy: Safe and Cost-effective Alternative to Ileostomy After Rectal Resection for Deep Infiltrating Endometriosis. In Vivo. 2022 May-Jun;36(3):1290-1296. doi: 10.21873/invivo.12829.

  PMID: 35478159 RESULT

Related Links

• Standard operating procedure on the treatment of colorectal cancer in Germany

MeSH Terms

Interventions

Ileostomy

Intervention Hierarchy (Ancestors)

Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Claudia L Rudroff, PhD MD

  EVK Koeln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department for Visceral Surgery and Surgery of the lower Gastrointestinal Tract

Model Details: Ghost ileostomy (short: ghost stoma) as an alternative to protective loop ileostomy or no outlet after colorectal resection

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: October 5, 2020
• Study Start: January 31, 2019
• Primary Completion: March 20, 2022
• Study Completion: March 20, 2022
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)