Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge

Not Applicable

Recruiting

• Conditions: Colorectal Disorders
• Interventions: Procedure: Right Hemicolectomy

• Registration Number: NCT03862781
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

Detailed Description

The purpose of this trial is to investigate whether minimally invasive right colectomies done with an intra-corporeal anastomosis result in quicker return of bowel function and earlier discharge. The primary endpoint of this study will be return of bowel function as measured by passage of flatus and bowel motions. The secondary endpoints will be inpatient length of stay, incision length, postoperative narcotic use, surgical site infection (superficial, deep and organ-space), perioperative morbidity and operating room charges.

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Eligible patients are those over 18 years of age who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. Right colectomy will be defined as removal of the ascending colon, ligation of the ileocolic artery and vein, +/- removal of the terminal ileum, +/- removal of the proximal transverse colon, and +/- removal of the right branch of the middle colic artery and vein.

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Exclusion Criteria

• Pregnant women
• Additional colon resection is planned (i.e. left colectomy or proctectomy)
• Vulnerable populations such as prisoners or adults unable to give consent
• If the scheduled surgery is planned at Butterworth hospital (as to standardize the nursing care received postoperatively)
• Emergent cases

Patients will be excluded from the study intra-operatively if:

• The procedure is converted to an open resection
• If a loop ileostomy is performed in addition to the right colectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-corporeal	Right Hemicolectomy	Right Hemicolectomy
Extra-corporeal	Right Hemicolectomy	Right Hemicolectomy

Primary Outcome Measures

Name	Time	Method
Return of bowel function	up to 2 weeks	Flatus and bowel motions

Secondary Outcome Measures

Name	Time	Method
Incision length	Surgery date	cm's
Perioperative morbidity	Baseline (Prior to surgery)	Disease state
Inpatient length of stay	up to 2 weeks	Days in the hospital after surgery
Postoperative narcotic use	up to 2 weeks	Average pain scores over first 5 hospital days
Surgical site infection	up to 6 weeks	(superficial, deep and organ-space)
Operating room charges	Surgery date	Fees for operating room

Trial Locations

Locations (1)

Spectrum Health Medical Group; 🇺🇸 Grand Rapids, Michigan, United States