Day-Case Closure of Loop Ileostomy in Rectal Cancer

NCT ID: NCT02774447

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-03-31

Brief Summary

The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.

Detailed Description

For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.

Conditions

Ileostomy Closure in Rectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Rectal cancer patients with ileostoma

In association with anterior resection of rectal cancer these patients obtain loop-ileostoma in order to avoid complications. These are closed within a few months and according to previous studies the admission time is 3-5 days after operation. This study is a single-arm study. The arm include patients having had rectal cancer operation and who have obtained a loop-ileostoma and that meet the inclusion criteria.

The operation procedure is standardized; shortly described by dissecting the ileostoma from the abdominal wall and everting the stoma ledges, which will be sutured or stapled. The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will be followed up.

ileostoma closure

Intervention Type: PROCEDURE

The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.

Interventions

ileostoma closure

The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults not older than 80 planed for closure of ileostomy
• The patient should not have had the ileostomy for more than 1 year
• Informed written consent should be given
• The patient should have a phone
• Should have an adult supervision at home for the first 24 hours after discharge
• American Society of Anesthesiologists (ASA) classification 1-2

Exclusion Criteria

• ASA classification 3 and above
• The pre-operative investigation have shown anastomosis leakage or stricture
• Dementia or other cognitive dysfunction
• The need of an interpreter
• Patients assessed not being able to manage themselves at home post-operative
• Insulin treated diabetes
• Coagulopathy
• Other organ dysfunction
• Bleeding more than 300 ml
• If converted to laparatomy
• Other intraoperative difficulties leading to suspected increased risk of complication

Discharge criteria:

• Stable vital parameters regarding circulation and respiration
• No sign of bleeding
• Pain relief possible through per oral administration
• Emptied urinary bladder
• Able to maintain per oral nutrition
• Mobilization possible
• Obtained oral and written information about symptoms of sepsis and bowel obstruction
• Obtained telephone number of a contact-nurse
• Obtained time for wound-inspection at the surgical unit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbas Chabok, Phd, MD

Role: STUDY_DIRECTOR

Centrum for Clinical Research Västerås/Uppsala University

Locations

Landstinget Västmanland,Centrum för klinisk forskning

Västerås, , Sweden

Countries

Sweden

References

Afshari K, Nikberg M, Smedh K, Chabok A. Loop-ileostomy reversal in a 23-h stay setting is safe with high patient satisfaction. Scand J Gastroenterol. 2021 Sep;56(9):1126-1130. doi: 10.1080/00365521.2021.1947367. Epub 2021 Jul 5.

Reference Type: DERIVED

PMID: 34224302 (View on PubMed)

Other Identifiers

Dnr 2014/363

Identifier Type: -

Identifier Source: org_study_id